Fosamax, one of the bisphosphonates 「雙磷酸鹽」manufactured by Merck & Co., was recently shown, in a study conducted by the U.S. Food and Drug Administration (FDA), to carry with it a higher incidence of osteonecrosis of the jaw or ONJ than other bisphosphonates. There is also evidence to suggest that Merck may have failed to promptly update its Fosamax label to report the danger, thereby causing millions of users to be at an unnecessary risk of developing the condition.
The concern with these medications and Fosamax in particular lies in the huge number of women taking these medications. Over 36 million women are taking them to prevent or slow osteoporosis. The number of women who use bisphosphonates has increased dramatically in recent years.
In the past, women relied on hormone replacement therapy to keep their bones healthy after menopause. But since recent studies linked estrogen with increased risk of heart disease and breast cancer, more women are taking Fosamax and other bisphosphonates at a younger age. Since these women use the medications for much longer time spans, they are at an increased risk of osteonecrosis of the jaw or ONJ.
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First Fosamax lawsuit Starts Aug 11,2009
The first of Fosamax jaw damage lawsuit is scheduled to go to trial on Aug 11,2009 in a Manhattan federal courtroom. According to Bloomberg.com, the Fosamax lawsuit is the first of three so-called bellwether cases, the outcomes of which may determine if there will be out-of-court settlements in other cases.
The first Fosamax lawsuit slated for trial involves a 71-year-old Florida woman who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006, Reuters said. According to the Reuters report, two other Fosamax lawsuits are scheduled to go to trial later this year, one in federal court and another in a state court in Alabama.
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See more information about Fosamax:
Generic Name:
Alendronate, Alendronate Sodium
Brand Names:
Fosamax, Fosamax+D
Manufacturer: Merck & Co., Inc.
FDA Approved:
September 29, 1995
Recall/Black Box Warning Information:
In 2004, the FDA ordered Fosamax to include a warning to alert patients of the risk of osteonecrosis (ONJ) of the jaw that is irreversible, as studies have shown a possible link between using Fosamax and developing ONJ. ONJ is a destruction of bone tissue and can lead to infection, jawbone breakdown, ulcerations in the mouth, or osteomyelitis (inflammation of bone marrow).
On January 7, 2008, the FDA released an alert to inform consumers of the possibility of severe or incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates, including Fosamax and Fosamax+D. The pain may occur within days, months, or years of taking the drugs.
According to studies in April of 2008, Fosamax may be linked to an increased risk of serious atrial fibrillation (irregular heartbeat) in women.
