Long-Term Fosamax Side Effects to be Reviewed by FDA Panel This Week

An FDA advisory panel is scheduled to meet this week to review the potential risks associated with long-term use of Fosamax and other bisphosphonate medications, which have been linked to a potential risk of spontaneous femur fractures and a rare jaw bone condition, known as osteonecrosis of the jaw (ONJ). 

At meetings set to begin on Friday, a panel of outside experts will review whether the FDA should adjust the length of time Fosamax and other similar drugs are used or whether users should be required to take a “drug holiday” to reduce the risk of the serious and potentially debilitating problems associated with long-term use.

Although Fosamax is designed to strengthen the bones and reduce the risk of fractures associated with osteoporosis, long-term Fosamax side effects have been linked to decay of the jaw bone and reports of rare femur fractures.

Osteonecrosis of the jaw, which is also known as ONJ or jaw necrosis, can be caused when side effects of Fosamax and other bisphosphonates interrupt the flow of blood to the jaw. This can lead to the deterioration or death of the jaw bone, which may result in the need for surgery to remove portions of the jaw. As the drug is used over long periods of time, it can build up within the body, increasing the risk of the painful and disfiguring jaw problems developing.

In recent years, long term use of bisphosphonate medications has also been linked to an increased risk of bone fractures, as a growing number of people have reported suffering spontaneous and unexplained femur fractures on Fosamax, which often occur with little or no trauma at all. Side effects of Fosamax 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 thigh fractures from Fosamax and other bisphosphonate medications. During a review of the potential Fosamax side effects, the FDA determined that the risk of fractures of the thigh bone may be connected to long-term use of bisphosphonates.

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

Although the recommendations of the advisory panel will not be binding on the FDA, the agency is usually influenced significantly by the outside experts that are convened to review safety concerns.