Friday, September 24, 2010

Euro-Zone Safety Review: Merck's Fosamax®, And Stress Fractures

The EU's drug regulator, the EMEA, has begun conducting a safety review of Fosamax® (and similar drugs in this class), per Reuters, just now:

. . . .European drugs regulators said they had started a safety review of a class of osteoporosis bone drugs called bisphosphonates after studies suggested a possible link to stress fractures.

The review by the European Medicines Agency follows a statement from the U.S. Food and Drug Administration earlier this month, which said it may require bisphosphonates to carry new information related to unusual femur fractures.

The bisphosphonate class includes Fosamax, made by Merck. . . .

As ever, we'll keep you up to date. In about a month, the next Fosamax ONJ bellwether trial gets underway in Manhattan's federal courthouse.

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