Merck Responds to News Reports about FOSAMAX^® (alendronate sodium) Tablets

ABC News has run stories this week about bisphosphonates including FOSAMAX that miss several key points which we believe viewers and online readers should know.

The FDA's statement on these stories is available here: http://www.fda.gov/
Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

The following is the transcript of the video statement Merck provided on Tuesday to ABC News featuring Dr. Michael Rosenblatt, M.D., Chief Medical Officer of Merck.

"Nothing is more important to Merck than the safety of our medicines. We study the safety and efficacy of our medicines extensively before approval, and for years and years after they are approved.

"FOSAMAX is a good example of this. FOSAMAX was approved in 1995, and we have conducted studies in tens of thousands of patients with osteoporosis that have shown that Fosamax increases bone mineral density and reduces the risk of fractures including those of the hip and spine. The efficacy, and the fact that osteoporosis is so common, are two of the reasons that these medicines are so widely used. FOSAMAX, and the other bisphosphonates, have been used in millions of women in the U.S. and around the world.

"Merck remains absolutely committed to studying the safety of FOSAMAX. When talking about reports of potential side effects, it's important to keep in mind that these events can and do occur in people who have never taken one of these medicines. But we are committed to continuing to study these reports, and to provide updates on what we learn. Based on what we know now, we believe that the benefits of bisphosphonates outweigh potential risks.

"FOSAMAX should not be used in patients with certain disorders of the esophagus that delay emptying, who are unable to stand or sit upright for at least 30 minutes, who have low levels of calcium in their blood, or in patients who are allergic to FOSAMAX. Patients who develop severe bone, joint and/or muscle pain at any time should contact their doctor. Osteonecrosis of the jaw, generally associated with tooth extraction and or/local infection, often with delayed healing, has been reported in patients taking bisphosphonates."

Additional information about FOSAMAX follows.

FOSAMAX is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces the incidence of fracture, including those of the hip and spine. FOSAMAX is also indicated to increase bone mass in men with osteoporosis.

Important Information About FOSAMAX
FOSAMAX, like other bisphosphonate containing products, should be used with caution in people with certain stomach or digestive problems. FOSAMAX should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, FOSAMAX should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to FOSAMAX or in patients who are pregnant or nursing. Patients who have difficulty swallowing liquids should not take FOSAMAX oral solution.

Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal experiences appears to be greater in patients who fail to follow dosing instructions (see prescribing information for more details). Patients who experience new or worsening heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and call their doctor right away. Patients who develop severe bone, joint and/or muscle pain at any time should contact their doctor. FOSAMAX may cause jawbone problems, which may include infection and delayed healing after teeth are pulled.

The standard dosing regimen for FOSAMAX includes swallowing the tablet with six to eight ounces of plain water the first thing upon arising for the day and at least 30 minutes before the first food, beverage or medication of the day. After swallowing FOSAMAX, patients should not lie down for at least 30 minutes and not until after consuming their first food of the day. Patients should not chew or suck on a tablet of FOSAMAX.

For Prescribing Information:
FOSAMAX^® (alendronate sodium) Tablets and Oral Solution, click here
FOSAMAX PLUS D^® (alendronate sodium/cholecalciferol) Tablets, click here

For Medication Guide:
FOSAMAX^® (alendronate sodium) Tablets and Oral Solution, click here
FOSAMAX PLUS D^® (alendronate sodium/cholecalciferol) Tablets, click here

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