Fosamax Fracture Problems Will Be Subject at FDA Panel Meeting

By Harvey Kirk
Posted September 7, 2011

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A panel of outside advisors to the FDA will meet this week to review the risks associated with long-term use of Fosamax and other bisphosphonate medications. One of the big concerns that will be addressed is the risk of Fosamax femur fractures and what regulatory steps should be taken to reduce the risk of these painful and debilitating broken bones from Fosamax.

>>MORE INFO: Fosamax Fracture Lawsuits

For the past three years, Saiontz & Kirk, P.A. has been investigating potential product liability lawsuits for users of the popular osteoporosis drug who have experienced a sudden femur fracture on Fosamax, which typically occur with little or no trauma. Complaints that are being pursued throughout the United States allege that Merck & Co. failed to adequately warn about the risk of Fosamax fracture problems, and has not taken sufficient steps to minimize the risk for users of the medication.

Fosamax (alendronate sodium) has been prescribed to millions of people in the United States since it was approved in 1995. It is the most popular seller in the family of bone-strengthening drugs known as bisphosphonates, which are the subject of the FDA advisory panel meetings set to begin on Friday.

Merck has promoted and encouraged the long-term use of Fosamax for treatment of osteoporosis and Pagets disease of the bone. However, Fosamax has an extremely long half-life, which means that it remains in the system for years and there can be a dose accumulation effect the longer it is taken.

Side effects of Fosamax long-term use have been linked to a number of serious, painful and potentially disabling problems. In addition to an association with low-trauma femur fractures, it has also been associated with decay or deterioration of the jaw bone, known as Fosamax jaw necrosis.

The FDA advisory panel will make recommendations to the FDA about regulatory options that could be enforced to minimize the risk of Fosamax problems. The panel will likely discuss potential limits on the number of years that women should take Fosamax and whether doctors should be told to have their patients take temporary breaks from using Fosamax, known as a “drug holiday” to reduce the risk of jaw decay and femur fracture problems with Fosamax.

FOSAMAX LAWSUIT FOR FAILURE TO REDUCE RISK

Although information has been available to Merck for some time about the risks associated with their blockbuster medication, they failed to take steps that could have been taken to reduce the risk of femur fractures or jaw necrosis from Fosamax. In fact, while providing inadequate warnings, Merck has encouraged the long-term use of the medication, rather than recommending limits on use or drug holidays, which would have negatively impacted sales of the blockbuster medication.

Individuals who have experienced problems may be entitled to financial compensation through a Fosamax lawsuit. To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.