FDA Panel to Discuss Bisphosphonate Side Effects in September

A Food & Drug Administration (FDA) advisory panel is set to discuss the safety issues surrounding bone drugs like <"http://www.yourlawyer.com/topics/overview/actos">Actonel, <"http://www.yourlawyer.com/topics/overview/Boniva">Boniva and <"http://www.yourlawyer.com/topics/overview/Boniva">Fosamax on September 9. According to a report from Dow Jones Newswire, the drugs – known as bisphosphonates – are used by about 5 million Americans.

Fosamax and other bisphosphonates have been associated with two very serious side effects – osteonecrosis of the jaw (aka dead jaw syndrome) and atypical fractures of the thigh. Last year, the FDA added information to the “Warnings and Precautions” section of the drugs labels’ describing the risk of atypical thigh fractures. There have been at least 300 reports of atypical thigh fractures in patients taking the drugs, often for longer than five years, Dow Jones said.

In 2005, the FDA ordered that the labels bisphosphonates be updated to include warnings about dead jaw syndrome.

Both issues have spawned a wave of product liability litigation, with alleged victims of Fosamax jaw problems and thigh fractures filing suit against Merck & Co. In May, the U.S. Judicial Panel on Multidistrict Litigation consolidated all pending and future Fosamax thigh fracture lawsuits in a multidistrict litigation an transferred them to the U.S. District Court for the District of New Jersey for pretrial proceedings.

Fosamax lawsuits claiming the drug caused dead jaw syndrome were already consolidated in a multidistrict litigation in New York in 2006.

An FDA advisory panel advisory panel will try to determine if the bisphophonate jaw problems and thigh fracture issues are related to long-term use of the drugs. They may, among other things, recommend guidelines for duration of use. The FDA would not be legally bound to follow the advisor panel’s recommendations, but in most cases it does so.

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