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Label Changes Needed To Reduce Risk of Problems from Fosamax: FDA Panel

A panel of drug experts convened by the FDA has stopped short of calling for a specific time limit on the use of Fosamax and other bone-strengthening drugs, instead recommending that additional label information be added about potential problems associated with long-term use, which could include an increased risk of osteonecrosis of the jaw (ONJ) and sudden femur fractures

The recommendations came from an FDA advisory panel that met last week. The Panel voted 17 to 6 to recommend that the FDA require drug makers to provide more information about the risks and benefits associated with bisphosphonate medications, which are commonly used for treatment of osteoporosis. Fosamax is the most widely used drug in the class, which also includes Actonel, Boniva and others.

The panel left how those warnings should be worded up to the FDA. While the federal drug regulatory agency is not required to follow the advice of their advisory panels, it is usually heavily influenced by the recommendations.

New label information would likely warn users about the reduced benefits from Fosamax and other bisphophonates after they have been taken for several years, and the potential risk of serious and debilitating injuries that could result as the medications build up in the body over a number of years.

According to documents released in advance of the panel meeting, some FDA staffers strongly believe that a five year time limit should be placed on taking the drugs, indicating that women get the most benefit in treating osteoporosis during the first three years on the medications.

Although bisphosphonates are designed to strengthen the bones and reduce the risk of fractures associated with osteoporosis, side effects of long-term Fosamax use have been linked to a possible risk of spontaneous femur fractures, which often occur with little or no trauma at all, and a rare jaw bone condition that causes the deterioration and decay of the jaw.

For several years, there have been concerns about the risk of osteonecrosis of the jaw from Fosamax or other similar drugs. Also known as ONJ or jaw necrosis, this rare jaw condition can be caused when bisphosphonate medications interrupt the flow of blood to the jaw, which can lead to the deterioration or death of the jaw bone. In many cases, individuals who develop ONJ require surgery to remove portions of the jaw.

More recently, concerns surrounding long term use of bisphosphonate medications have also been linked to an increased risk of spontaneous femur fractures, as a growing number of people have reported suffering unexplained fractures on Fosamax. Side effects of bisphosphonate medications may weaken the ability of the femur bone to repair itself from microdamage, increasing the risk of a sudden femur fracture.

In October 2010, the FDA required new warnings about the risk of femur fractures from Fosamax and other bisphosphonate medications. The agency indicated at that time that the risk of fractures appeared to be connected to long-term use of bisphosphonates.

Merck & Co. currently faces hundreds of Fosamax jaw decay lawsuits and Fosamax femur fracture lawsuits that have been filed by individuals who claim the drug maker failed to adequately warn about the potential side effects.

Many critics have argued that Merck and other drug makers could have taken additional steps to make sure consumers and the medical community were aware about the risk of problems associated with long-term bisphosphonate use. According to some complaints filed against Merck, the drug maker has encouraged long-term use of the medication and minimized the risk of problems from Fosamax, rather than recommending limits on the length of time the medication should be used, which may have negatively impacted sales of the blockbuster medication.

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