Wednesday, October 13, 2010

FDA Warns Of Thigh Fracture Risks | The Ongoing Fosamax® Files

We've been pointing to this for over a year, now; now FDA is joining the EMEA in warning about femur fractures in patients on long term, uninterrupted alendronate regimens (per Reuters). Alendronate is sold by Merck as Fosamax® (among other manufacturers, including generic companies):

. . . .Widely used osteoporosis drugs may raise the risk of an unusual type of thigh fracture, U.S. health officials warned on Wednesday.

All medicines in the class known as bisphosphonates will carry a new warning about the fractures, the Food and Drug Administration said in a statement.

The drugs, used by millions over the past decade, include Merck & Co's Fosamax, Roche Holding AG's Boniva, Novartis AG's Reclast and Warner Chilcott Plc's Actonel.

Fosamax also is sold generically under the name alendronate. . . .

We will, as ever, keep you posted -- as this develops at FDA.


Anonymous said...

I'm sure you're aware but....if not~checkout Pharmalot. Ed's reporting the delay to the arbitration for Remicade.

condor said...

Yep -- was in client meetings this morning, but I now have a pair of pieces on it. Thanks, and. . .