Fda Investigation Of Fosamax And Femur Fractures

Fosamax femur fracture information

Fosamax, a respected osteoporosis drug made by the pharmaceutical giant Merck, is in the spotlight this week, as its relationship to dangerous Fosamax femur fractures comes under federal review. Studies have tied Fosamax, which is administered to women at risk for osteoporosis, to a deterioration of bones which can lead to abnormal fractures of the thigh, even in the absence of a fall.

These research results are part ofa body of increasingly persuasive data linking Fosamax and femur fractures. The studies suggest that exposure to Fosamax for more than 3 to 5 years can cause health hazards, leading to fragileness that can weaken normally durable femur bones and cause fluky femur fractures.

FDA investigation of Fosamax and femur fractures

In early September, the FDA convened a committee of experts to analyze years of safety studies and finally determine just what dangers the drug actually poses. Fosamaxs original clinical trials didnt collect data for users taking the drug for longer than 5 years. Recent studies have shown that these long-term users face the worst risks for weak bones leading to Fosamax femur fractures.

These results have compelled the FDA to analyze the drug and gauge its dangers. The FDA may choose to impose drug holidays - essentially, periods of downtime off the drug to temper the risks of continued exposure - or even to issue a recall.

Fosamax litigation on the rise

As the FDA considers the future of Fosamax, victims of Fosamax femur fractures are assessing their Fosamax litigation prospects and Merck is preparing for potential litigation. Hundreds of lawsuits have already been filed against Merck, alleging that the company didnt properly advertize the dangers of Fosamax femur fractures.

The amount of Fosamax lawsuits is partially attributable to the popularity of the drug. There are an estimated 4 million users of Fosamax, mostly older women. The drug was one of the first available treatments for osteoporosis.

It works by restricting a type of bone renewal process known as resorption. Restricting resorption can help prevent injury to womens hips and other bones, but has now been to increase bone mass onto womens femurs while actually sapping their durability. This process is thought to be at the root of strange cases where Fosamax users have suffered clean breaks of the biggest bone in their body while walking on flat surfaces or climbing stairs.

The immediate future of Fosamax and femur fractures

Recently, the FDA announced that they will make Merck to add new labels to products that can cause these femur fractures. The warnings must include information about the risks of long-term Fosamax use and recommend an appropriate window of use. With completion of the FDAs review finished, the fate of Fosamax is uncertain.

Patients on the drug could need to prepare for the drugs withdrawal or for FDA-imposed drug holidays. Victims of Fosamax femur fractures also stand to gain new data pertinent to treatment and Fosamax litigation.