FDA On Merck’s Fosamax Suggest No Problems

By: Bill Waters
03/12/2010 11:28 AM ET

The Food and Drug Administration posted a notice on its website regarding the FDA on Fosamax. It is currently reviewing two reports that suggest women and men with osteoporosis may actually increase the chance of femur fractures when taking bone-building drugs. One of the drugs is Fosamax.

There are many questions about the drug and its possible safety issues. However, the agency added that a previous look from a 2008 study did not show that the drugs could increase the risk of fracture in the bone below the hip joint. The study conducted in 2008 showed patients with similar results when taking bisphosphonates than those not taking the drug.

Fosamax might also be linked to a woman’s risk of developing atrial fibrillation and a chronic irregular heart beat that can cause dizziness. The 2008 study was conducted by the University of Washington. In addition, the drug had other risks such as fainting, fatigue and in rare cases it can lead to blood clots and stroke.

Investigators at Columbia University Medical Center and Hospital for Special Surgery (HSS) both conclude more research is needed. Until there are more answers, the FDA insists that those that already use the medications should continue to take them. Bisphosphonates currently on the market includes Fosamax (Merck), Actonel (P & G), Reclast (Novartis), and Boniva (Roche, GSK).

Bone-Building Business Is Lucrative

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 pursuant to 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.

Counterfeit Surgical Mesh Recall

The U.S. Food and Drug Administration warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States. The product is using the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

The warning is of particular significance to health care professionals and their patients with surgical mesh implants. They are also used in hospitals and surgical centers. Moreover, operating room medical professionals and staff also use them.

The federal agency recommends that health care professionals continue to monitor patients for adverse events. Especially the patients with an authentic polypropylene surgical mesh implant. Patients should contact their surgeon if they experience problems that they think may be related to surgical mesh.

The FDA continues to gather information and data on the counterfeit mesh to better understand its potential public health impact. The agency also is working to determine who may be responsible and how the counterfeiting and distribution occurred. The FDA assessment and investigation is ongoing.

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