FDA RespondsTo Fosamax Studies

FDA Responds To Research

The Food and Drug Administration posted a response to two reports issued Wednesday that women and men with osteoporosis may actually increase the chance of femur fractures when taking bone-building drugs, such as Fosamax.

After the two studies questioned the long-term use of bisphosphonates, the FDA posted on its Website a notice that it will look into the safety issue.

But the agency added that a 2008 look at the question did not show that the drugs could increase the risk of fracture in the bone below the hip joint.

Bone Quality or Bone Quantity

The two separate recent studies suggest that long-term use of bisphosphonate that slow or stop bone loss occurring during the natural bone remodeling cycle, may alter the properties of bone, making them less structurally sound, more brittle and prone to breaking.

In other words, users may be substituting bone quantity for bone quality after prolonged use.

But in its communication, the FDA says a December 2008 article in Journal of Bone and Mineral Research concluded that the data shows that “patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures.”

In 2008, researchers at the University of Washington found that Fosamax use was linked to a woman’s risk of developing atrial fibrillation, (AF) a chronic irregular heart beat that can cause dizziness and fainting as well as fatigue and in rare cases it can lead to a blood clots and stroke.

More Research Needed

Investigators at Columbia University Medical Center and Hospital for Special Surgery (HSS) both conclude more research is needed.

Until there are further answers, the agency says those on the medications should continue taking them. Bisphosphonates currently on the market include Fosamax (Merck), Actonel (P & G), Reclast (Novartis), and Boniva (Roche, GSK).

The bone-building business is a lucrative one topping $3.5 billion in sales annually. Both Pfizer (Fablyn) and Amgen (Denosumab) have bone-building drugs in the FDA pipeline that have suffered delays in approval as a result of the controversy.

The FDA answers will be telling for the 900 or so product liability lawsuits against Fosamax which claim the drug caused the death of their jaw-bone tissue. The first such case ended in a jury deadlock last September. #