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In the Media

article imageLong Term Fosamax Use May Cause Brittle Bones in Some Women

article:288892:6::0
Bill
By Bill Lindner
Mar 10, 2010 in Health
By Bill Lindner.
Mounting evidence is suggesting that using Fosamax, a popular drug prescribed to women suffering from osteoporosis, for more than five years may be causing brittle bones that are more susceptible to fractures in some women
Mounting evidence is showing that using Merck & Co's Fosamax -- one in a class of drugs called bisphosphonates often prescribed to women diagnosed with osteoporosis because it's supposed to make bones stronger -- or its generic alendronate for more than five years may actually cause brittle bones that are more susceptible to spontaneous bone fractures in some women.
Sandy Potter, a 59-year-old Queens, New York woman, was diagnosed with osteoporosis when she was 48. Potter had reportedly been taking Fosamax for eight years before her femur literally snapped in two while she was jumping rope with neighborhood children.
Sue Heller, a 60-year-old Castle Rock, CO woman, had been taking Fosamax for almost ten years when she broke both of her femur bones.
Dr. Kenneth Egol, Professor of Orthopedic surgery at NYU Langone Medical Center, told ABC News they are seeing this more frequently over the last 18 months. "We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise. Very unusual, the femur is one of the strongest bones in the body."
Fosamax Already Linked to Osteonecrosis and Severe Musculoskeletal Pain
Dr. Egol said some of his patients x-rays look more like an injury from a car accident than a minimal fall.
Fosamax sales rose when doctors started prescribing it to women who were osteopenic, in addition to women diagnosed with osteoporosis. Now some doctors are worried that staying on the drug for more than five years can cause some women's bones to become more brittle.
Over 37 million prescriptions were written for the osteoporosis medications in 2008 and bisphosphonate sales exceeded $3.5 billion according to data from IMS health.
As noted by ABC, this is not the first time many doctors have reported an opposite effect for many people taking the drug and Fosamax has already been linked to osteonecrosis, a serious bone-related jaw disease and to severe musculoskeletal pain. In early 2007 Merck & Co. was bracing for a flood of Fosamax lawsuits.
In a written response, Merck responded "In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare reports consistent with osteonecrosis of the jaw have been received. Many of these reports lack sufficient clinical details to make definitive assessments and/or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown. Rare cases of ONJ have also been reported in patients who do not have osteoporosis and who have not taken any bisphosphonate medicines" to the suggested link.
Research Does Not Indicate How Long Women Should Use Fosamax
It took Merck 16 months to add reports of femur fractures from patients to the list of possible side effects in Fosamax's package insert after the Food and Drug Administration (FDA) reached out to them about the reports in 2008.
Dr. Richard Besser, ABC News Senior Health and Medical Editor, noted that in addition to Merck taking an entire year to respond, the FDA has also never made an effort to inform the public or doctors across the country that are prescribing bisphosphonates about the possible side effect.
The FDA and Merck declined to be interviewed by ABC News but the FDA said reports of fractures are being looked into. The FDA's record on keeping Americans safe from dangerous drugs is less than stellar. A written statement by Merck to ABC News said that a casual relationship between Fosamanx and the fractures has not been established.
There are many studies suggesting that there is an overall benefit to women at risk for osteoporosis from taking the medication, and bisphosphonates can help prevent hip and spine fractures, which may lead to death for many women.
Bisphosphonates are generally recommended for postmenopausal women, but research does not indicate how long women should remain on it. Many doctors are now recommending a five-year limit.
article:288892:6::0
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