The FDA's failure to implement heightened standards for prescription use of Fosamax has blossomed into a growing concern for doctors, who say thousands of osteoporosis patients continue to be exposed to risks
NEW YORK, Feb. 23, 2012 — Doctors and other healthcare professionals have grown increasingly concerned about the regulation paradigm the Food & Drug Administration is taking with regard to Fosamax – a widely used osteoporosis drug, as evidence of its link to abnormal bone fractures.
The FDA has so far resisted adding labeling requirements to Fosamax's packaging that would warn against prolonged use. Such labels are necessary in light of the dangers long-term use of the drug poses to patients with already weak bones, according to leading medical experts.
Multiple clinical studies have linked Fosamax and femur fractures. The drug, which is supposed to strengthen bones by inhibiting a process called resorption, may actually lead to the severe, irregular fractures some patients have reported.
Dozens of women have reported experiencing these Fosamax femur fractures in accidents where they experienced very minimal impacts, the jolt of walking down steps or a bumpy car ride in some cases being enough to cause severe transverse femur fractures.
An FDA panel convened in September to discuss heightening regulations on the drug, but no action has been taken since.
According to Merck, the drug's manufacturer, Fosamax underwent the customary clinical trials that demonstrate a product's safety for use. These trials lasted for only three to five years, however, while many patients who suffered these unique Fosamax bone fractures had taken the drug for six years or more.
The lawyers of thousands of patients who suffered Fosamax femur fractures say that the lack of labeling regarding this five-year window is central to their clients' Fosamax lawsuits. According to legal experts, drug companies like Merck have a duty to warn patients about the risks their products pose.
Standard Fosamax labeling does not contraindicate use of the drug beyond any particular number of years.
One option that some healthcare professionals have recommended to the FDA is requiring "drug holidays," periods of time away from a drug to lower the risk of side effects.
However, the FDA has not implemented any such precautions. No upcoming action regarding Fosamax labeling has been announced by the agency.
Meanwhile thousands of patients already harmed by the drug continue to file Fosamax lawsuits against Merck.
Contact:
Weitz & Luxenberg P.C.
Bert Phillips, 1-212-558-5840
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