Researchers indicate that they have found a causal link between nonhealing femur fractures and Fosamax side effects, providing further support for lawsuits filed by hundreds of former users of the osteoporosis medication who have experienced devastating injuries following an atypical femur fracture.
In a study funded in part by the National Institutes of Health, researchers looked at the FDA adverse event reporting database and determined that rare and nonhealing femur fractures are not just associated with taking Fosamax and similar drugs, but directly caused by them. The findings were published last month in the Journal of Bone & Joint Surgery.
The investigators looked at the FDA Adverse Event Reporting System (FAERS) database and found a proportional reporting ration of 4.51 between the use of Fosamax and similar drugs and nonhealing femoral fractures. In most of those cases, the person took Fosamax.
Fosamax (alendronate sodium) was introduced by Merck in 1995, for treatment and prevention of osteoporosis. Before it became available as a generic in 2008, the medication generated over $3 billion in annual sales and was used by millions of Americans. It is one of a family of bone drugs known as bisphosphonates.
While Fosamax is designed to strengthen bones and reduce the risk of fractures associated with osteoporosis, long-term use of the medication has been linked to an increased risk of low-trauma bone fractures, where the femur may completely break after little or no trauma at all.
In October 2010, following an investigation by the FDA, Merck was required to add new warnings about the risk of bone fractures from Fosamax. These warnings provided new information for consumers and the medical community about the importance of identifying symptoms of new hip or groin pain, which could occur before an atypical fracture of the femur.
Merck now faces about 3,000 Fosamax femur fracture lawsuits in state and federal courts throughout the country, alleging that the drug maker failed to provide adequate warnings about the risks associated with long-term use of the medications.
The first Fosamax trial involving a femur fracture is currently underway in New Jersey state court, involving a lawsuit brought by Christina Su, a New Jersey woman who fractured both femurs after taking the osteoporosis drug for nearly six years.