Did Merck Know About Fosamax Fracture Risk?

New York, NYMerck may have buried data on Fosamax fracture risk, according to media reports of the second Fosamax (Alendronate) lawsuit currently before the courts. According to a report by Bloomberg.com, Paul Pennock, the attorney representing Bernadette Glynn, Merck knew there was a risk of bone brittleness and an increased fracture risk with the osteoporosis drug five years before it was made available to the public.

Glynn, who used the bisphosphonate Fosamax for seven years, alleges her femur spontaneously fractured when she bent over to pick up something in April 2009. Glynn, now 58, states in her lawsuit that her leg was repaired with surgery and the use of rods. She was 54 when her femur snapped.

Merck is currently facing some 3300 lawsuits alleging the osteoporosis drug caused femur fractures with more than 1000 other cases linking the bone drug to osteonecrosis of the jaw (ONJ).

Merck, for their part, claims doctors and patients were appropriately warned. However, Glynn’s attorney stated "This company should have warned of the problems that they saw coming," (as quoted by Bloomberg). "The company should have warned of the problems they learned actually were happening."

In 2010, data from a study highlighted a potential risk of femur fractures in people taking Fosamax and similar bone-strengthening drugs. Having reviewed the data, the FDA added warnings to the drugs' labels, and cautioned doctors about the long-term use of bisphosphonates. In 2011, an FDA advisory panel also looked at the drugs' risks, which includes leg-fracture data. The expert advisers favored warnings and perhaps restrictions on long-term bisphosphonate use.