New York, NYThere have been about 1,000 lawsuits filed in the US alleging Fosamax osteonecrosis, which is a condition popularly known as dead jaw. However, there are other issues related to Fosamax. To that end the US Food and Drug Administration (FDA) issued a warning to consumers October 13th with regard to bisphosphonates (Fosamax among them).
The FDA is saying that a drug designed to combat bone thinning and the loss of bone related to osteoporosis can actually lead to certain fractures of the thigh bone.
It is somewhat of a paradox that a drug designed to afford the preservation of bone could be the root cause of bone fracture.
"While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates,'' the FDA said in a statement published October 14th in the Boston Globe.
Sandra Kweder, deputy director of the FDA's office of new drugs in the Center for Drug Evaluation and Research, indicated that the FDA is continuing to evaluate data with regard to long-term treatment of osteoporosis. "In the interim, it's important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.''
The Boston Globe reported that the issue is more common with those patients who have been taking bisphosphonates—including Fosamax—for five years or longer.
Brittle bones are not the only issue with Fosamax, however. As noted above, Fosamax side effects include a paradoxical breakdown of bone in the jaw, a health issue that can cause grievous health issues over the long term. Hence the high number of lawsuits claiming that Fosamax manufacturer Merck brought Fosamax to market in 1995 without warning users of the potential for Fosamax ONJ, or "dead jaw syndrome."
Fosamax lawsuits have been consolidated in Multi District Litigation (MDL) in US District Court Manhattan. Two bellwether cases have resulted in one ruling apiece for the plaintiff (in one case) and the defendant (in the other).
A third bellwether Fosamax dead jaw case is scheduled for opening arguments November 1st. Jury selection is slated for October 28 in US District Court for the Southern District of New York. In that case, Judith Graves of Palm Coast, Florida, alleges that Fosamax caused her to develop Fosamax osteonecrosis of the jaw.
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