Wednesday, March 10, 2010

FDA Formally To Look Into "Fosamax® Fractures": WSJ Online


Per the Wall Street Journal, just now:

. . . .The Food and Drug Administration said Wednesday it's conducting a safety review of certain bone-building drugs like Fosamax® and Boniva to see if they increase the risk of femur fractures.

The review involves a class of drugs known as bisphosphonates, which are commonly prescribed to treat osteoporosis and are designed to build bone mass. Drugs in the class include Actonel, marketed by Sanofi Aventis SA and Procter & Gamble Co.; Boniva, marketed by Roche Holding AG and GlaxoSmithKline PLC; and Merck & Co.'s Fosamax.

The agency said it was looking at reports about whether there's an increased risk of atypical subtrochanteric femur fractures—fractures in the bone just below the hip joint—in some patients who've been on the drugs for several years. . . .

While no cause-effect connection -- between long-term Fosamax® use, and femur fractures --has been definitively established thus far, there are now two separate studies pointing in that general direction. We'll keep an eye on this.

1 comment:

Anonymous said...

Fosamax, A Drug in Litigation, Under FDA Review

The Fosamax (Alendronate) study done for FDA approval failed to show any benefit for the majority of the worried well, which is the osteopenia group defined as T score greater than -2.5. This Osteopenia Group actually had higher fracture rates than placebo. This data was data published by Cummings in JAMA in 1998 Fracture Intervention Trial.

Bisphosphonate drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain.

The spontaneous mid femur fractures are especially troubling, since these are spontaneous fractures without any trauma. Subtrochanteric fractures are pathological fractures, indicating the underlying bone matrix is abnormal. This anormal weakening and brittleness is directly caused by the bisphosphonate drug.

Bottom Line: These are BAD drugs that actually make the bones weaker not stronger, and they should be banned by the FDA . However, knowing the FDA which is in the pocket of the drug companies, no action will be taken until many more women victims suffer from these drugs, and many more cases work their way through drug litigation court..

To read more...http://www.drdach.com/Fosamax.html