Another day, another blockbuster falls off the cliff, as Merck bids farewell to the Fosamax patent and $3 billion in annual sales.
NEW YORK (CNNMoney.com) -- Merck & Co. bids adieu to its bone disease blockbuster drug on Wednesday, when the patent finally runs out on Fosamax.
Once the patent expires on the osteoporosis drug Fosamax, generic drugmakers Teva Pharmaceuticals (TEVA) and Barr Laboratories (BRL) will roll out their low-cost versions. That's great news for patients, but bad news for Merck (MRK, Fortune 500), because sales will plunge.
Fosamax sales totaled $3 billion in 2007, but Merck projects that 2008 sales will decline by at least half that, followed by further erosion later on.
In all, this will be a difficult year for Big Pharma, and a rich one for generic drugmakers. Some $20 billion worth of drugs are expected to lose patent protection in 2008, according to the market research firm IMS Health.
But the New Jersey-based drugmaker has had decades to prepare for this day and has found ways to plug the impending sales vacuum with a mixture of new products and cost-cutting. Analysts expect this formula to stem the tide, projecting a 2% increase in sales for 2008 and a 5% increase in earnings, according to Thomson First Call.
"[The Fosamax patent expiration] is sort of in the rear view mirror at this point," said Barbara Ryan, analyst for Deutsche Bank North America. "Everybody's known it was coming. It's baked into expectations."
Of course, Merck has had other problems to contend with, such as the 2004 withdrawal of the arthritis painkiller Vioxx, once a $2.5 billion-a-year blockbuster, as well as the ensuing $4.85 billion lawsuit settlement.
But after the Vioxx debacle, Merck launched a $5 billion cost-cutting program, shedding 7,200 jobs so far. More importantly - from a growth standpoint - the company expects sales for its respiratory drug Singulair to exceed $4.5 billion this year. And the company's newly-launched products have done well so far. Sales for the cervical cancer vaccine Gardasil, launched in 2006, grew to $1.5 billion in 2007. Also in 2007, combined sales for diabetes drugs Januvia and Janumet exceeded $700 million.
Also, Merck is awaiting decisions this year from the Food and Drug Administration on two prospective money-makers: Cordaptive, a cholesterol drug that some analysts consider a potential billion-dollar blockbuster, and taranabant, a diet drug with a more uncertain future because of possible safety issues.
"I think people are looking past Fosamax," said Michael Krensavage, analyst for Raymond James & Associates. "I think the company should be able to overcome the loss."
But going forward, the patent issue will continue to dog Big Parma. Merck faces with its next big patent expiration in 2010, when the $3 billion-a-year Cozaar/Hyzaar hypertension franchise loses protection.
Also in 2010, Pfizer's (PFE, Fortune 500) cholesterol drug Lipitor loses patent protection. Lipitor is the top-selling drug of all time, with nearly $13 billion in 2006 sales.
Visit http://fosamaxhealth.blogspot.com for a free legal guide regarding Fosamax Class Action Lawsuit.
Sunday
Trouble Brews Over Merck FOSAMAX Product
Trouble Brews Over Merck Product
Wall Street Journal
1/30/2008 - Merck & Co.'s pending $4.85 billion Vioxx settlement is expected to bring more than three years of litigation to an end. But looming challenges to some top-selling products, including osteoporosis blockbuster Fosamax, threaten to keep the company under a cloud.
The headline headache of late has been Vytorin. For months, critics have assailed how Merck and Schering-Plough Corp. handled disappointing trial results for their anticholesterol drug. A congressional probe has yet to reach full speed, and New York and Connecticut officials have disclosed investigations. Investors will be looking for an update as Merck reports earnings today.
The company's Gardasil cervical-cancer vaccine has drawn scrutiny after a small number of physicians and patients reported serious side effects to federal regulators. While regulators have deemed Gardasil safe, some individual incidents have provided ammunition for those who opposed Merck's push last year for states to mandate the vaccine for schoolgirls. Merck's Gardasil sales totaled $1.4 billion for the first nine months of last year.
But Fosamax presents one of the bigger question marks to Merck's bottom line. A growing number of patients allege the bone-strengthening drug causes a bone-wasting condition called osteonecrosis of the jaw, or ONJ. Meanwhile, researchers and regulators are scrutinizing other potential negative effects, like bone breakdowns elsewhere in the body and severe pain.
Should the legal challenges pass, Fosamax could face others. It loses patent protection in the U.S. next week, which means it soon will bring in a lot less than the roughly $3 billion it rang up in 2006.
Merck has said it stands behind Vytorin's efficacy and safety and dismisses concerns about Gardasil as unfounded. It also defends Fosamax, saying clinical evidence shows no rise in fractures related to the drug and that the label already warns of pain.
Merck has set aside $48 million in Fosamax litigation reserves for about 340 cases filed as of Sept. 30, a significantly lower sum than the billion dollar-plus fund it had set aside for the tens of thousands of Vioxx suits. But the company could face substantial hurdles in court due to the nature of the alleged injuries. Vioxx, a painkiller pulled from the market in 2004, was associated with heart attacks and strokes, which are common and might have been caused by a number of factors. Plaintiffs' lawyers say ONJ is what is known in legal circles as a signature injury, or a type of injury that is easier to link to a drug.
On Monday, a federal judge denied class-action certification for the Fosamax litigation, meaning claims will move forward on an individual basis.
Merck's stock has taken a beating of late. Since releasing the Vytorin study's disappointing results Jan. 14, the shares are down about 20%, and were at $48 yesterday in New York Stock Exchange composite trading.
The Whitehouse Station, N.J., company in December offered a promising earnings forecast for this year of between $3.96 and $4.06 a share, up from an expected $1.45 to $1.51 a share in 2007. Now, says Michael Krensavage, an analyst with Raymond James & Associates, the Vytorin flap "certainly will undermine the company's results in 2008."
On Monday, plaintiffs' lawyer Tim O'Brien, who heads the plaintiffs' steering committee in the ONJ cases, filed the first lawsuit related to a non-jaw injury. The suit, filed in a Camden County, N.J., state court, involves a plaintiff who claims her stress fractures were due to Fosamax toxicity, or an accumulation of the drug in the body. Unlike many drugs that have a short shelf life in the body, Fosamax -- which belongs to a category known as bisphosphonates -- stays in the body for 10 years.
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures. Fosamax reduces activity of the cells that cause bone loss and can increase the amount of bone.
Mr. O'Brien's suit filed Monday involves 53-year-old JoAnn Moranski, who claims she took Fosamax for 8? years for osteoporosis. "I was religious about it," she says. "I didn't miss a day." In 2003, she claims to have begun experiencing debilitating pain in her legs and eventually walked with a cane. A physician told her last year that she had suffered a series of stress fractures, which he attributed to her use of Fosamax, she alleges in her lawsuit.
Paul Strain, a partner at the law firm Venable LLP, who represents Merck, called the suit "an isolated claim," and said clinical evidence didn't find any increased risk of fractures with Fosamax. "We would have found it; we looked for it and it wasn't there."
The Food and Drug Administration, in response to physician reports, on Jan. 7 issued an alert flagging "the possibility of severe and sometimes incapacitating bone, joint, and/or muscle [musculoskeletal] pain in patients taking bisphosphonates."
The alert said that although severe musculoskeletal pain is included in the label's prescribing information for all bisphosphonates, the link may be overlooked by health-care professionals. It said the pain may occur within days, months or years of use.
Merck spokesman Ronald Rogers said such musculoskeletal pain has already been recognized for this class of drugs and that such information already is provided to physicians. He said the company has received reports of bone, muscle and joint pain since Fosamax was introduced in 1995 that are in line with the precautions on the label.
In a recent study involving nearly 88,000 people reported in the Journal of Rheumatology, scientists found that those taking oral bisphosphonate medications have nearly three times the risk of developing osteonecrosis, compared with those not taking them. "The risk is increased for nonspecific osteonecrosis," says Mahyar Etminan, a pharmacoepidemiologist at Centre for Clinical Epidemiology and Evaluation and the University of British Columbia.
Mr. Strain, the attorney representing Merck, said, "What I'm confident about is that the overwhelming majority of surgeons would say that if there is ONJ induced by oral bisphosphonates, it happens extremely rarely."
The first Fosamax cases involving ONJ are expected to be tried next year. Thomas Dodson, an associate professor at Massachusetts General Hospital who has done jaw-repair surgery on bisphosphonates users who went on to develop ONJ, says it is difficult to estimate the frequency of ONJ in Fosamax users. Prevalence estimates range from one in 100,000 to one in 300, he says. Nonbisphosphonate ONJ is estimated to occur in one in 3,800 people.
"The reason it's kind of a major concern is that people have been getting prescribed Fosamax at the drop of a hat," he says. "Even if it's rare, there are so many people taking Fosamax, it's going to be a problem." Dr. Dodson isn't connected to the Fosamax litigation.
For more information regarding Fosamax and osteoporosis, visit http://fosamaxhealth.blogspot.com.
Wall Street Journal
1/30/2008 - Merck & Co.'s pending $4.85 billion Vioxx settlement is expected to bring more than three years of litigation to an end. But looming challenges to some top-selling products, including osteoporosis blockbuster Fosamax, threaten to keep the company under a cloud.
The headline headache of late has been Vytorin. For months, critics have assailed how Merck and Schering-Plough Corp. handled disappointing trial results for their anticholesterol drug. A congressional probe has yet to reach full speed, and New York and Connecticut officials have disclosed investigations. Investors will be looking for an update as Merck reports earnings today.
The company's Gardasil cervical-cancer vaccine has drawn scrutiny after a small number of physicians and patients reported serious side effects to federal regulators. While regulators have deemed Gardasil safe, some individual incidents have provided ammunition for those who opposed Merck's push last year for states to mandate the vaccine for schoolgirls. Merck's Gardasil sales totaled $1.4 billion for the first nine months of last year.
But Fosamax presents one of the bigger question marks to Merck's bottom line. A growing number of patients allege the bone-strengthening drug causes a bone-wasting condition called osteonecrosis of the jaw, or ONJ. Meanwhile, researchers and regulators are scrutinizing other potential negative effects, like bone breakdowns elsewhere in the body and severe pain.
Should the legal challenges pass, Fosamax could face others. It loses patent protection in the U.S. next week, which means it soon will bring in a lot less than the roughly $3 billion it rang up in 2006.
Merck has said it stands behind Vytorin's efficacy and safety and dismisses concerns about Gardasil as unfounded. It also defends Fosamax, saying clinical evidence shows no rise in fractures related to the drug and that the label already warns of pain.
Merck has set aside $48 million in Fosamax litigation reserves for about 340 cases filed as of Sept. 30, a significantly lower sum than the billion dollar-plus fund it had set aside for the tens of thousands of Vioxx suits. But the company could face substantial hurdles in court due to the nature of the alleged injuries. Vioxx, a painkiller pulled from the market in 2004, was associated with heart attacks and strokes, which are common and might have been caused by a number of factors. Plaintiffs' lawyers say ONJ is what is known in legal circles as a signature injury, or a type of injury that is easier to link to a drug.
On Monday, a federal judge denied class-action certification for the Fosamax litigation, meaning claims will move forward on an individual basis.
Merck's stock has taken a beating of late. Since releasing the Vytorin study's disappointing results Jan. 14, the shares are down about 20%, and were at $48 yesterday in New York Stock Exchange composite trading.
The Whitehouse Station, N.J., company in December offered a promising earnings forecast for this year of between $3.96 and $4.06 a share, up from an expected $1.45 to $1.51 a share in 2007. Now, says Michael Krensavage, an analyst with Raymond James & Associates, the Vytorin flap "certainly will undermine the company's results in 2008."
On Monday, plaintiffs' lawyer Tim O'Brien, who heads the plaintiffs' steering committee in the ONJ cases, filed the first lawsuit related to a non-jaw injury. The suit, filed in a Camden County, N.J., state court, involves a plaintiff who claims her stress fractures were due to Fosamax toxicity, or an accumulation of the drug in the body. Unlike many drugs that have a short shelf life in the body, Fosamax -- which belongs to a category known as bisphosphonates -- stays in the body for 10 years.
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures. Fosamax reduces activity of the cells that cause bone loss and can increase the amount of bone.
Mr. O'Brien's suit filed Monday involves 53-year-old JoAnn Moranski, who claims she took Fosamax for 8? years for osteoporosis. "I was religious about it," she says. "I didn't miss a day." In 2003, she claims to have begun experiencing debilitating pain in her legs and eventually walked with a cane. A physician told her last year that she had suffered a series of stress fractures, which he attributed to her use of Fosamax, she alleges in her lawsuit.
Paul Strain, a partner at the law firm Venable LLP, who represents Merck, called the suit "an isolated claim," and said clinical evidence didn't find any increased risk of fractures with Fosamax. "We would have found it; we looked for it and it wasn't there."
The Food and Drug Administration, in response to physician reports, on Jan. 7 issued an alert flagging "the possibility of severe and sometimes incapacitating bone, joint, and/or muscle [musculoskeletal] pain in patients taking bisphosphonates."
The alert said that although severe musculoskeletal pain is included in the label's prescribing information for all bisphosphonates, the link may be overlooked by health-care professionals. It said the pain may occur within days, months or years of use.
Merck spokesman Ronald Rogers said such musculoskeletal pain has already been recognized for this class of drugs and that such information already is provided to physicians. He said the company has received reports of bone, muscle and joint pain since Fosamax was introduced in 1995 that are in line with the precautions on the label.
In a recent study involving nearly 88,000 people reported in the Journal of Rheumatology, scientists found that those taking oral bisphosphonate medications have nearly three times the risk of developing osteonecrosis, compared with those not taking them. "The risk is increased for nonspecific osteonecrosis," says Mahyar Etminan, a pharmacoepidemiologist at Centre for Clinical Epidemiology and Evaluation and the University of British Columbia.
Mr. Strain, the attorney representing Merck, said, "What I'm confident about is that the overwhelming majority of surgeons would say that if there is ONJ induced by oral bisphosphonates, it happens extremely rarely."
The first Fosamax cases involving ONJ are expected to be tried next year. Thomas Dodson, an associate professor at Massachusetts General Hospital who has done jaw-repair surgery on bisphosphonates users who went on to develop ONJ, says it is difficult to estimate the frequency of ONJ in Fosamax users. Prevalence estimates range from one in 100,000 to one in 300, he says. Nonbisphosphonate ONJ is estimated to occur in one in 3,800 people.
"The reason it's kind of a major concern is that people have been getting prescribed Fosamax at the drop of a hat," he says. "Even if it's rare, there are so many people taking Fosamax, it's going to be a problem." Dr. Dodson isn't connected to the Fosamax litigation.
For more information regarding Fosamax and osteoporosis, visit http://fosamaxhealth.blogspot.com.
FOSAMAX Lawsuit Update
Fosamax, also known as alendronate, is a medication used for bone loss, but has been implicated in the serious necrosis of the jaw and other bones, a condition known as "osteonecrosis" (ONJ) – also called "bone death."
Recent studies, however, suggest a link between the use of bisphosphonates, such as Fosamax, and osteonecrosis. This condition is associated with the interference of the blood supply to the bone and the consequential damage that occurs. The majority of the reported cases are in cancer patients who are having, or have had, a dental procedure.
Fosamax can also irritate the esophagus, and care must be taken in order to avoid such irritation. Recently, researchers discovered that taking Fosamax in combination with the popular arthritis drug Naproxin may increase the risk of developing stomach ulcers.
The U.S. Food and Drug Administration asked Merck to add a warning to Fosamax's label in August of 2004 and it has yet to comply with that request. In a statement, Merck said that in all of its clinical trials of Fosamax, which have included more than 17,000 patients, it has not had any reports of osteonecrosis of the jaw. Merck said that there have been reports of patients taking Fosamax developing the condition but that doesn't necessarily mean the drug caused it.
Fosamax is taken by nearly 10 million men and women. Fosamax is Merck's second best-selling drug with last year's revenue at $3.2 billion.
Visit http://fosamaxhealth.blogspot.com for a free guide regarding Fosamax Class Action Lawsuit.
Recent studies, however, suggest a link between the use of bisphosphonates, such as Fosamax, and osteonecrosis. This condition is associated with the interference of the blood supply to the bone and the consequential damage that occurs. The majority of the reported cases are in cancer patients who are having, or have had, a dental procedure.
Fosamax can also irritate the esophagus, and care must be taken in order to avoid such irritation. Recently, researchers discovered that taking Fosamax in combination with the popular arthritis drug Naproxin may increase the risk of developing stomach ulcers.
The U.S. Food and Drug Administration asked Merck to add a warning to Fosamax's label in August of 2004 and it has yet to comply with that request. In a statement, Merck said that in all of its clinical trials of Fosamax, which have included more than 17,000 patients, it has not had any reports of osteonecrosis of the jaw. Merck said that there have been reports of patients taking Fosamax developing the condition but that doesn't necessarily mean the drug caused it.
Fosamax is taken by nearly 10 million men and women. Fosamax is Merck's second best-selling drug with last year's revenue at $3.2 billion.
Visit http://fosamaxhealth.blogspot.com for a free guide regarding Fosamax Class Action Lawsuit.
What is FOSAMAX?
What is FOSAMAX?
FOSAMAX is a prescription medicine for:
FOSAMAX is a prescription medicine for:
- The treatment or prevention of osteoporosis (thinning of bone) in women after menopause. It reducesthe chance of having a hip or spinal fracture (break).
- Treatment to increase bone mass in men with osteoporosis.
- The treatment of osteoporosis in either men or women who are taking corticosteroid medicines (for example, prednisone).
Improvement in bone density may be observed as early as 3 months after you start taking FOSAMAX even though you won’t see or feel a difference. For FOSAMAX to continue to work, you need to keep taking it.
FOSAMAX is not a hormone.
There is more information about osteoporosis at http://fosamaxhealth.blogspot.com
What is FOSAMAX PLUS D?
What is FOSAMAX PLUS D?
FOSAMAX PLUS D is a prescription medicine that contains alendronate sodium and vitamin D3(cholecalciferol) as the active ingredients. FOSAMAX PLUS D provides a week’s worth of vitamin D3. Some patients may need more vitamin D than is in FOSAMAX PLUS D. Your doctor may recommend an additional vitamin D supplement.
FOSAMAX PLUS D is used for:
- The treatment of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip or spinal fracture (break).
- Treatment to increase bone mass in men with osteoporosis.
Improvement in bone density may be observed as early as 3 months after you start taking FOSAMAX PLUS D even though you won’t see or feel a difference. For FOSAMAX PLUS D to continue to work, you need to keep taking it.
FOSAMAX PLUS D should not be used to treat vitamin D deficiency.
FOSAMAX PLUS D is not a hormone.
FOSAMAX PLUS D is not for use in premenopausal women.
There is more information about osteoporosis and vitamin D at the end of this leaflet.
FOSAMAX and FOSAMAX PLUS D Cautionary Information
Selected Cautionary Information About FOSAMAX and FOSAMAX PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX or FOSAMAX PLUS D. Before use, talk to your doctor if you have or have had stomach or digestive problems or problems with swallowing. You should tell your doctor about all medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements. In addition, for FOSAMAX PLUS D, you should talk to your doctor if you have conditions that may cause an overproduction of vitamin D (eg, sarcoidosis, leukemia, lymphoma).
Stop taking FOSAMAX or FOSAMAX PLUS D and call your doctor right away if you develop new or worsening heartburn, difficult or painful swallowing, or chest pain because these may be signs of serious upper digestive problems, which can include irritation, inflammation, or ulceration of the esophagus. (See the Patient Product Information for more details.) If you develop severe bone, joint, and/or muscle pain at any time, contact your doctor. Digestive side effects in studies were generally mild and included stomach pain, indigestion/heartburn, or nausea.
FOSAMAX Dosage and Administration
FOSAMAX Administration and FOSAMAX Dosage
FOSAMAX must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSAMAX (see PRECAUTIONS, Drug Interactions). Waiting less than 30 minutes, or taking FOSAMAX with food, beverages (other than plain water) or other medications will lessen the effect of FOSAMAX by decreasing
its absorption into the body.
FOSAMAX should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX tablet should be swallowed with a full glass of water (6-8 oz). To facilitate gastric emptying FOSAMAX oral solution should be followed by at least 2 oz (a quarter of a cup) of water. Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences.
Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate.
No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). FOSAMAX is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Treatment of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE)
The recommended dosage is:
- one 70 mg tablet once weekly
or - one bottle of 70 mg oral solution once weekly
or - one 10 mg tablet once daily
Treatment to increase bone mass in men with osteoporosis
The recommended dosage is:
- one 70 mg tablet once weekly
or - one bottle of 70 mg oral solution once weekly
or - one 10 mg tablet once daily
Prevention of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE)
The recommended dosage is:
- one 35 mg tablet once weekly
or - one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with FOSAMAX has been studied for up to 7 years.
FOSAMAX Overdosage
Overdosage of FOSAMAX
Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg
(3256 mg/m2) and 966 mg/kg (2898 mg/m2), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m2).
No specific information is available on the treatment of overdosage with FOSAMAX. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Dialysis would not be beneficial.
Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg
(3256 mg/m2) and 966 mg/kg (2898 mg/m2), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m2).
No specific information is available on the treatment of overdosage with FOSAMAX. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Dialysis would not be beneficial.
FOSAMAX Dosing Instructions
FOSAMAX Dosing Direction and Dosing Instructions
General Physicians should instruct their patients to read the patient package insert before starting therapy with FOSAMAX and to reread it each time the prescription is renewed.
Patients should be instructed to take supplemental calcium and vitamin D, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.
Patients should be instructed that the expected benefits of FOSAMAX may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of FOSAMAX (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Absorption).
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation patients should be instructed to swallow each tablet of FOSAMAX with a full glass of water (6-8 oz). To facilitate gastric emptying patients should drink at least 2 oz (a quarter of a cup) of water after taking FOSAMAX oral solution. Patients should be instructed not to lie down for at least 30 minutes and until after their first food of the day. Patients should not chew or suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take FOSAMAX at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Patients should be instructed that if they develop symptoms of esophageal disease(such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking FOSAMAX and consult their physician.
Patients should be instructed that if they miss a dose of once weekly FOSAMAX, they should take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
General Physicians should instruct their patients to read the patient package insert before starting therapy with FOSAMAX and to reread it each time the prescription is renewed.
Patients should be instructed to take supplemental calcium and vitamin D, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.
Patients should be instructed that the expected benefits of FOSAMAX may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of FOSAMAX (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Absorption).
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation patients should be instructed to swallow each tablet of FOSAMAX with a full glass of water (6-8 oz). To facilitate gastric emptying patients should drink at least 2 oz (a quarter of a cup) of water after taking FOSAMAX oral solution. Patients should be instructed not to lie down for at least 30 minutes and until after their first food of the day. Patients should not chew or suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take FOSAMAX at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Patients should be instructed that if they develop symptoms of esophageal disease(such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking FOSAMAX and consult their physician.
Patients should be instructed that if they miss a dose of once weekly FOSAMAX, they should take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
FOSAMAX General Precautions
General Precautions for FOSAMAX
Causes of osteoporosis other than estrogen deficiency, aging, and glucocorticoid use should be considered.
Hypocalcemia must be corrected before initiating therapy with FOSAMAX (see
CONTRAINDICATIONS). Other disorders affecting mineral metabolism (such as vitamin D deficiency)should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with FOSAMAX.
Presumably due to the effects of FOSAMAX on increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur, especially in patients with Paget’s disease, in whom the pretreatment rate of bone turnover may be greatly elevated and in patients receiving glucocorticoids, in whom calcium absorption may be decreased.
Ensuring adequate calcium and vitamin D intake is especially important in patients with Paget’s disease of bone and in patients receiving glucocorticoids.
For free legal consultation with a qualified Fosamax Lawyer, visit http://fosamaxhealth.blogspot.com.
Causes of osteoporosis other than estrogen deficiency, aging, and glucocorticoid use should be considered.
Hypocalcemia must be corrected before initiating therapy with FOSAMAX (see
CONTRAINDICATIONS). Other disorders affecting mineral metabolism (such as vitamin D deficiency)should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with FOSAMAX.
Presumably due to the effects of FOSAMAX on increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur, especially in patients with Paget’s disease, in whom the pretreatment rate of bone turnover may be greatly elevated and in patients receiving glucocorticoids, in whom calcium absorption may be decreased.
Ensuring adequate calcium and vitamin D intake is especially important in patients with Paget’s disease of bone and in patients receiving glucocorticoids.
For free legal consultation with a qualified Fosamax Lawyer, visit http://fosamaxhealth.blogspot.com.
FOSAMAX Warnings
Fosamax Warnings and Precautions
WARNINGS for FDA-approved FOSAMAX
FOSAMAX, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa.
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with FOSAMAX. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible
esophageal reaction and patients should be instructed to discontinue FOSAMAX and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking FOSAMAX and/or who fail to swallow it with the recommended amount of water, and/or who continue to take FOSAMAX after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION). In patients who cannot comply with dosing instructions due to mental
disability, therapy with FOSAMAX should be used under appropriate supervision.
Because of possible irritant effects of FOSAMAX on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when FOSAMAX is given to patients with active upper gastrointestinal problems (such as dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers).
There have been post-marketing reports of gastric and duodenal ulcers, some severe and with complications, although no increased risk was observed in controlled clinical trials.
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WARNINGS for FDA-approved FOSAMAX
FOSAMAX, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa.
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with FOSAMAX. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible
esophageal reaction and patients should be instructed to discontinue FOSAMAX and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking FOSAMAX and/or who fail to swallow it with the recommended amount of water, and/or who continue to take FOSAMAX after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION). In patients who cannot comply with dosing instructions due to mental
disability, therapy with FOSAMAX should be used under appropriate supervision.
Because of possible irritant effects of FOSAMAX on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when FOSAMAX is given to patients with active upper gastrointestinal problems (such as dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers).
There have been post-marketing reports of gastric and duodenal ulcers, some severe and with complications, although no increased risk was observed in controlled clinical trials.
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FOSAMAX Indications and Usage
FOSAMAX Indications and Usage
FOSAMAX is indicated for:
Treatment and prevention of osteoporosis in postmenopausal women
- For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces the
incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.) - For the prevention of osteoporosis, FOSAMAX may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture. Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors
often associated with the development of postmenopausal osteoporosis include early
menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of FOSAMAX for prevention of osteoporosis.
Treatment to increase bone mass in men with osteoporosis
Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density (see PRECAUTIONS, Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
Treatment of Paget’s disease of bone in men and women- Treatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
FOSAMAX - Prevention of Osteoporosis in Postmenopausal Women
Fosamax Osteoporosis Prevention
FOSAMAX - Prevention of Osteoporosis in Postmenopausal Women
Prevention of bone loss was demonstrated in two double-blind, placebo-controlled studies of postmenopausal women 40-60 years of age. One thousand six hundred nine patients (FOSAMAX 5 mg/day; n=498) who were at least six months postmenopausal were entered into a two-year study without regard to their baseline BMD. In the other study, 447 patients (FOSAMAX 5 mg/day; n=88), who were between six months and three years postmenopause, were treated for up to three years. In the placebo-treated patients BMD losses of approximately 1% per year were seen at the spine, hip (femoral neck and trochanter) and total body. In contrast, FOSAMAX 5 mg/day prevented bone loss in the majority of patients and induced significant increases in mean bone mass at each of these sites (see figures below). In addition, FOSAMAX 5 mg/day reduced the rate of bone loss at the forearm by approximately half relative to placebo. FOSAMAX 5 mg/day was similarly effective in this population regardless of age, time since menopause, race and baseline rate of bone turnover.
FOSAMAX - Prevention of Osteoporosis in Postmenopausal Women
Prevention of bone loss was demonstrated in two double-blind, placebo-controlled studies of postmenopausal women 40-60 years of age. One thousand six hundred nine patients (FOSAMAX 5 mg/day; n=498) who were at least six months postmenopausal were entered into a two-year study without regard to their baseline BMD. In the other study, 447 patients (FOSAMAX 5 mg/day; n=88), who were between six months and three years postmenopause, were treated for up to three years. In the placebo-treated patients BMD losses of approximately 1% per year were seen at the spine, hip (femoral neck and trochanter) and total body. In contrast, FOSAMAX 5 mg/day prevented bone loss in the majority of patients and induced significant increases in mean bone mass at each of these sites (see figures below). In addition, FOSAMAX 5 mg/day reduced the rate of bone loss at the forearm by approximately half relative to placebo. FOSAMAX 5 mg/day was similarly effective in this population regardless of age, time since menopause, race and baseline rate of bone turnover.
FOSAMAX - Effect on Fracture Incidence
Fosamax Effect on Fractures
FOSAMAX - Effect on Fracture Incidence
Data on the effects of FOSAMAX on fracture incidence are derived from three clinical studies: 1) U.S. and Multinational combined: a study of patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture, 2) Three-Year Study of the Fracture Intervention Trial (FIT): a study of patients with at least one baseline vertebral fracture, and 3) Four-Year Study of FIT: a study of patients with low bone mass but without a baseline vertebral fracture.
To assess the effects of FOSAMAX on the incidence of vertebral fractures (detected by digitized radiography; approximately one third of these were clinically symptomatic), the U.S. and Multinational studies were combined in an analysis that compared placebo to the pooled dosage groups of FOSAMAX (5 or 10 mg for three years or 20 mg for two years followed by 5 mg for one year). There was a statistically significant reduction in the proportion of patients treated with FOSAMAX experiencing one or more new vertebral fractures relative to those treated with placebo (3.2% vs. 6.2%; a 48% relative risk reduction). A reduction in the total number of new vertebral fractures (4.2 vs. 11.3 per 100 patients) was also observed.
In the pooled analysis, patients who received FOSAMAX had a loss in stature that was statistically significantly less than was observed in those who received placebo (-3.0 mm vs. -4.6 mm).
The Fracture Intervention Trial (FIT) consisted of two studies in postmenopausal women: the Three-Year Study of patients who had at least one baseline radiographic vertebral fracture and the Four-Year Study of patients with low bone mass but without a baseline vertebral fracture. In both studies of FIT, 96% of randomized patients completed the studies (i.e., had a closeout visit at the scheduled end of the study); approximately 80% of patients were still taking study medication upon completion.
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FOSAMAX - Effect on Fracture Incidence
Data on the effects of FOSAMAX on fracture incidence are derived from three clinical studies: 1) U.S. and Multinational combined: a study of patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture, 2) Three-Year Study of the Fracture Intervention Trial (FIT): a study of patients with at least one baseline vertebral fracture, and 3) Four-Year Study of FIT: a study of patients with low bone mass but without a baseline vertebral fracture.
To assess the effects of FOSAMAX on the incidence of vertebral fractures (detected by digitized radiography; approximately one third of these were clinically symptomatic), the U.S. and Multinational studies were combined in an analysis that compared placebo to the pooled dosage groups of FOSAMAX (5 or 10 mg for three years or 20 mg for two years followed by 5 mg for one year). There was a statistically significant reduction in the proportion of patients treated with FOSAMAX experiencing one or more new vertebral fractures relative to those treated with placebo (3.2% vs. 6.2%; a 48% relative risk reduction). A reduction in the total number of new vertebral fractures (4.2 vs. 11.3 per 100 patients) was also observed.
In the pooled analysis, patients who received FOSAMAX had a loss in stature that was statistically significantly less than was observed in those who received placebo (-3.0 mm vs. -4.6 mm).
The Fracture Intervention Trial (FIT) consisted of two studies in postmenopausal women: the Three-Year Study of patients who had at least one baseline radiographic vertebral fracture and the Four-Year Study of patients with low bone mass but without a baseline vertebral fracture. In both studies of FIT, 96% of randomized patients completed the studies (i.e., had a closeout visit at the scheduled end of the study); approximately 80% of patients were still taking study medication upon completion.
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Osteoporosis in Men - FOSOMAX
FOSOMAX - Treatment of Osteoporosis in Men
Treatment of men with osteoporosis with FOSAMAX 10 mg/day for two years reduced urinary excretion of cross-linked N-telopeptides of type I collagen by approximately 60% and bone-specific alkaline phosphatase by approximately 40%. Similar reductions were observed in a one-year study in men with osteoporosis receiving once weekly FOSAMAX 70 mg.
Treatment of men with osteoporosis with FOSAMAX 10 mg/day for two years reduced urinary excretion of cross-linked N-telopeptides of type I collagen by approximately 60% and bone-specific alkaline phosphatase by approximately 40%. Similar reductions were observed in a one-year study in men with osteoporosis receiving once weekly FOSAMAX 70 mg.
Osteoporosis in Postmenopausal Women - FOSAMAX
FOSAMAX - Treating Osteoporosis in Postmenopausal Women
Osteoporosis is characterized by low bone mass that leads to an increased risk of fracture. The diagnosis can be confirmed by the finding of low bone mass, evidence of fracture on x-ray, a history of osteoporotic fracture, or height loss or kyphosis, indicative of vertebral (spinal) fracture. Osteoporosis occurs in both males and females but is most common among women following the menopause, when bone turnover increases and the rate of bone resorption exceeds that of bone formation. These changes result in progressive bone loss and lead to osteoporosis in a significant proportion of women over age 50. Fractures, usually of the spine, hip, and wrist, are the common consequences. From age 50 to age 90, the risk of hip fracture in white women increases 50-fold and the risk of vertebral fracture 15- to 30-fold. It is estimated that approximately 40% of 50-year-old women will sustain one or more osteoporosis-related fractures of the spine, hip, or wrist during their remaining lifetimes. Hip fractures, in particular, are associated with substantial morbidity, disability, and mortality.
Daily oral doses of alendronate (5, 20, and 40 mg for six weeks) in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including decreases in urinary calcium and urinary markers of bone collagen degradation (such as deoxypyridinoline and crosslinked N-telopeptides of type I collagen). These biochemical changes tended to return toward baseline values as early as 3 weeks following the discontinuation of therapy with alendronate and did not differ from placebo after 7 months.
Long-term treatment of osteoporosis with FOSAMAX 10 mg/day (for up to five years) reduced urinary excretion of markers of bone resorption, deoxypyridinoline and cross-linked N-telopeptides of type l collagen, by approximately 50% and 70%, respectively, to reach levels similar to those seen in healthy premenopausal women. Similar decreases were seen in patients in osteoporosis prevention studies who received FOSAMAX 5 mg/day. The decrease in the rate of bone resorption indicated by these markers was evident as early as one month and at three to six months reached a plateau that was maintained for the entire duration of treatment with FOSAMAX. In osteoporosis treatment studies FOSAMAX 10 mg/day decreased the markers of bone formation, osteocalcin and bone specific alkaline phosphatase by approximately 50%, and total serum alkaline phosphatase, by approximately 25 to 30% to reach a plateau after 6 to 12 months. In osteoporosis prevention studies FOSAMAX 5 mg/day decreased osteocalcin and total serum alkaline phosphatase by approximately 40% and 15%, respectively. Similar reductions in the rate of bone turnover were observed in postmenopausal women during one-year studies with once weekly FOSAMAX 70 mg for the treatment of osteoporosis and once weekly FOSAMAX 35 mg for the prevention of osteoporosis. These data indicate that the rate of bone turnover reached a new steady-state, despite the progressive increase in the total amount of alendronate deposited within bone.
As a result of inhibition of bone resorption, asymptomatic reductions in serum calcium and phosphate concentrations were also observed following treatment with FOSAMAX. In the long-term studies, reductions from baseline in serum calcium (approximately 2%) and phosphate (approximately 4 to 6%) were evident the first month after the initiation of FOSAMAX 10 mg. No further decreases in serum calcium were observed for the five-year duration of treatment; however, serum phosphate returned toward prestudy levels during years three through five. Similar reductions were observed with FOSAMAX 5 mg/day. In one-year studies with once weekly FOSAMAX 35 and 70 mg, similar reductions were observed at 6 and 12 months. The reduction in serum phosphate may reflect not only the positive bone mineral balance due to FOSAMAX but also a decrease in renal phosphate reabsorption.
Osteoporosis is characterized by low bone mass that leads to an increased risk of fracture. The diagnosis can be confirmed by the finding of low bone mass, evidence of fracture on x-ray, a history of osteoporotic fracture, or height loss or kyphosis, indicative of vertebral (spinal) fracture. Osteoporosis occurs in both males and females but is most common among women following the menopause, when bone turnover increases and the rate of bone resorption exceeds that of bone formation. These changes result in progressive bone loss and lead to osteoporosis in a significant proportion of women over age 50. Fractures, usually of the spine, hip, and wrist, are the common consequences. From age 50 to age 90, the risk of hip fracture in white women increases 50-fold and the risk of vertebral fracture 15- to 30-fold. It is estimated that approximately 40% of 50-year-old women will sustain one or more osteoporosis-related fractures of the spine, hip, or wrist during their remaining lifetimes. Hip fractures, in particular, are associated with substantial morbidity, disability, and mortality.
Daily oral doses of alendronate (5, 20, and 40 mg for six weeks) in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including decreases in urinary calcium and urinary markers of bone collagen degradation (such as deoxypyridinoline and crosslinked N-telopeptides of type I collagen). These biochemical changes tended to return toward baseline values as early as 3 weeks following the discontinuation of therapy with alendronate and did not differ from placebo after 7 months.
Long-term treatment of osteoporosis with FOSAMAX 10 mg/day (for up to five years) reduced urinary excretion of markers of bone resorption, deoxypyridinoline and cross-linked N-telopeptides of type l collagen, by approximately 50% and 70%, respectively, to reach levels similar to those seen in healthy premenopausal women. Similar decreases were seen in patients in osteoporosis prevention studies who received FOSAMAX 5 mg/day. The decrease in the rate of bone resorption indicated by these markers was evident as early as one month and at three to six months reached a plateau that was maintained for the entire duration of treatment with FOSAMAX. In osteoporosis treatment studies FOSAMAX 10 mg/day decreased the markers of bone formation, osteocalcin and bone specific alkaline phosphatase by approximately 50%, and total serum alkaline phosphatase, by approximately 25 to 30% to reach a plateau after 6 to 12 months. In osteoporosis prevention studies FOSAMAX 5 mg/day decreased osteocalcin and total serum alkaline phosphatase by approximately 40% and 15%, respectively. Similar reductions in the rate of bone turnover were observed in postmenopausal women during one-year studies with once weekly FOSAMAX 70 mg for the treatment of osteoporosis and once weekly FOSAMAX 35 mg for the prevention of osteoporosis. These data indicate that the rate of bone turnover reached a new steady-state, despite the progressive increase in the total amount of alendronate deposited within bone.
As a result of inhibition of bone resorption, asymptomatic reductions in serum calcium and phosphate concentrations were also observed following treatment with FOSAMAX. In the long-term studies, reductions from baseline in serum calcium (approximately 2%) and phosphate (approximately 4 to 6%) were evident the first month after the initiation of FOSAMAX 10 mg. No further decreases in serum calcium were observed for the five-year duration of treatment; however, serum phosphate returned toward prestudy levels during years three through five. Similar reductions were observed with FOSAMAX 5 mg/day. In one-year studies with once weekly FOSAMAX 35 and 70 mg, similar reductions were observed at 6 and 12 months. The reduction in serum phosphate may reflect not only the positive bone mineral balance due to FOSAMAX but also a decrease in renal phosphate reabsorption.
Distribution of Fosamax
Fosamax Distribution
Preclinical studies (in male rats) show that alendronate transiently distributes to soft tissues following 1 mg/kg IV administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 L in humans. Concentrations of drug in plasma following therapeutic oral doses are too low (less than 5 ng/mL) for analytical detection. Protein binding in human plasma is approximately 78%.
Preclinical studies (in male rats) show that alendronate transiently distributes to soft tissues following 1 mg/kg IV administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 L in humans. Concentrations of drug in plasma following therapeutic oral doses are too low (less than 5 ng/mL) for analytical detection. Protein binding in human plasma is approximately 78%.
FOSAMAX Absorption
Fosamax Absorption
Fosamax Absorption
Relative to an intravenous (IV) reference dose, the mean oral bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardized breakfast. Oral bioavailability of the 10 mg tablet in men (0.59%) was similar to that in women when administered after an overnight fast and 2 hours before breakfast.
FOSAMAX 70 mg oral solution and FOSAMAX 70 mg tablet are equally bioavailable.
A study examining the effect of timing of a meal on the bioavailability of alendronate was performed in 49 postmenopausal women. Bioavailability was decreased (by approximately 40%) when 10 mg alendronate was administered either 0.5 or 1 hour before a standardized breakfast, when compared to dosing 2 hours before eating. In studies of treatment and prevention of osteoporosis, alendronate was effective when administered at least 30 minutes before breakfast.
Bioavailability was negligible whether alendronate was administered with or up to two hours after a standardized breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
Fosamax Absorption
Relative to an intravenous (IV) reference dose, the mean oral bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardized breakfast. Oral bioavailability of the 10 mg tablet in men (0.59%) was similar to that in women when administered after an overnight fast and 2 hours before breakfast.
FOSAMAX 70 mg oral solution and FOSAMAX 70 mg tablet are equally bioavailable.
A study examining the effect of timing of a meal on the bioavailability of alendronate was performed in 49 postmenopausal women. Bioavailability was decreased (by approximately 40%) when 10 mg alendronate was administered either 0.5 or 1 hour before a standardized breakfast, when compared to dosing 2 hours before eating. In studies of treatment and prevention of osteoporosis, alendronate was effective when administered at least 30 minutes before breakfast.
Bioavailability was negligible whether alendronate was administered with or up to two hours after a standardized breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
FOSAMAX and FOSAMAX PLUS D - FDA Approved
Fosamax and Fosamax Plus D
FOSAMAX and FOSAMAX PLUS D are FDA approved to reduce the risk of both hip and spine osteoporosis fractures in postmenopausal women.
FOSAMAX PLUS D treats postmenopausal osteoporosis. It actually helps reverse bone loss. Not just stop it, or slow it.
FOSAMAX PLUS D treats postmenopausal osteoporosis. It's the only treatment with vitamin D, which helps absorb calcium and build strong, healthy bones.
FOSAMAX PLUS D treats postmenopausal osteoporosis. It helps prevent fractures of both the hip and spine
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FOSAMAX® Description
FOSAMAX® DESCRIPTION:
FOSAMAX® (ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION
FOSAMAX® (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclastmediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.
The empirical formula of alendronate sodium is C4H12NNaO7P2•3H2O and its formula weight is 325.12. The structural formula is:
Fosamax Drug Description
Fosamax Drug Description
Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.
Tablets FOSAMAX for oral administration contain 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate. Tablets FOSAMAX 10 mg also contain carnauba wax.
Each bottle of the oral solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of free acid. Each bottle also contains the following inactive ingredients: sodium citrate dihydrate and citric acid anhydrous as buffering agents, sodium saccharin, artificial raspberry flavor, and purified water. Added as preservatives are sodium propylparaben 0.0225% and sodium butylparaben 0.0075%.
http://fosamaxhealth.blogspot.com/ provides comprehensive information regarding Fosamax.
FOSAMAX® (ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION
FOSAMAX® (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclastmediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.
The empirical formula of alendronate sodium is C4H12NNaO7P2•3H2O and its formula weight is 325.12. The structural formula is:
Fosamax Drug Description
Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.
Tablets FOSAMAX for oral administration contain 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate. Tablets FOSAMAX 10 mg also contain carnauba wax.
Each bottle of the oral solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of free acid. Each bottle also contains the following inactive ingredients: sodium citrate dihydrate and citric acid anhydrous as buffering agents, sodium saccharin, artificial raspberry flavor, and purified water. Added as preservatives are sodium propylparaben 0.0225% and sodium butylparaben 0.0075%.
http://fosamaxhealth.blogspot.com/ provides comprehensive information regarding Fosamax.
Generic Fosamax Approved
The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of a person's bones.
Teva Pharmaceuticals USA, North Wales, Pa., was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and two once-weekly dosing strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., Montvale, N.J., was approved to manufacture a 70 milligrams once-weekly dose of the drug.
"The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."
Fosamax is among the top 100 most frequently dispensed drugs in the United States, according to the trade magazine Drug Topics.
Generic drug manufacturers must demonstrate that a generic drug has the same active ingredient, dosage form, strength, route of administration, quality and performance characteristics, among other things, as the approved brand-name drug.
The labeling of the generic alendronate sodium tablets may differ from that of Fosamax because some portions of the labeling are protected by patents and exclusivity.
For more information visit FDA's Office of Generic Drugs http://fosamaxhealth.blogspot.com
Teva Pharmaceuticals USA, North Wales, Pa., was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and two once-weekly dosing strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., Montvale, N.J., was approved to manufacture a 70 milligrams once-weekly dose of the drug.
"The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."
Fosamax is among the top 100 most frequently dispensed drugs in the United States, according to the trade magazine Drug Topics.
Generic drug manufacturers must demonstrate that a generic drug has the same active ingredient, dosage form, strength, route of administration, quality and performance characteristics, among other things, as the approved brand-name drug.
The labeling of the generic alendronate sodium tablets may differ from that of Fosamax because some portions of the labeling are protected by patents and exclusivity.
For more information visit FDA's Office of Generic Drugs http://fosamaxhealth.blogspot.com