Muncie, INIt seems somewhat paradoxical that a drug designed to protect bone may be causing bone fractures, writes Jill U. Adams in the 3/22/10 edition of the Los Angeles Times. The incidence rate of Fosamax osteonecrosis (bone death of the jaw) is low, but two reports presented this month during a gathering of orthopedic surgeons have indicated that risks of the drug may outweigh the benefits.
Fosamax was the first drug in the bisphosphonate family to receive approval from the US Food and Drug Administration in 1995. Designed for patients suffering the effects of osteoporosis, bisphosphonates are intended to protect bone.
While the FDA has said as recently as last month that available evidence shows no clear link between bisphosphonates like Fosamax and atypical femur fractures, there are additional concerns over rare side effects such as osteonecrosis of the jaw, or dead jaw, thought to be triggered by dental work.
One case alleging Fosamax dead jaw is set to go to trial April 19. Merck, the manufacturer of Fosamax, did not wish to see the case go to trial and attempted to have the Louise Maley's lawsuit dismissed prior to her trial date.
Maley's is one of three bellwether cases set for trial in the federal court MDL (multi-district litigation), Drug Injury Watch reported in February. According to a November regulatory filing by Merck, the manufacturer faced 953 Fosamax lawsuits as of September 30. Some of those involved multiple patients.
Maley, of Muncie, Indiana, filed her complaint in May 2006 after developing osteonecrosis of the jaw (ONJ). She claims that Merck failed to warn about the dangers of Fosamax.
The LA Times reported in March that incidence rates for OJN hovered between one in 10,000 and one in 100,000. However, Dr. Daniel Solomon, a professor of medicine at Harvard Medical School, indicated that in his view the stated incidence rates might be significantly higher.
That said, there are those in the medical community who feel that the benefits of bisphosphonates such as Fosamax continue to outweigh the risks. Dr. Joseph Lane, who led a research team at New York's Hospital for Special Surgery that studied the effects of bisphosphonates on osteoporosis patients, told the LA Times that "these are wonderful drugs."
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