FDA to Review Safety of Osteoporosis Drugs as Lawsuit Begins in Bellwether Trial
Posted Sep 6, 2011 12:02 PM CDT
By Debra Cassens Weiss
The Food and Drug Administration is expected to review the safety of osteoporosis drugs taken over the long-term amid growing concerns about side effects.
The drugs, known as bisphosphonates, add bone mass by inhibiting a bone renewal process called resorption, the New York Times reports. The fear is that long-term use of the drugs can contribute to brittle bones, leading to fractures of the thigh and bone death in the jaw.
Two FDA panels have drafted questions for scientific advisers. They include whether the drugs are safe and effective for long-term use, and whether users should take “drug holidays.”
The review comes as jury selection begins for a bellwether Fosamax trial on product liability claims by Linda Secrest, who suffers from jaw problems. A federal judge ruled last week that Secrest could pursue a design defect claim but could not seek punitive damages or pursue a claim based on failure to warn, Reuters and the New York Law Journal reported last week.
The defendant, Merck, is facing more than 1,100 lawsuits alleging jaw damage and about 535 suits for thigh bone fractures and other bone injuries, the Times says. So far Merck has won three jaw damage cases and lost one.