The popular osteoporosis drug Fosamax (Alendronate) has been shown by medical studies to increase the risk of leg bone fractures (particularly in the femur), osteonecrosis bone decay in the jaw, and esophageal cancer. More than 1,000 Fosamax patients have filed lawsuits against Merck, the drug’s manufacturer, alleging the company negligently tested the drug and failed to warn patients of the real risks of taking Fosamax, particularly if taken for more than five years.
Fosamax is a bisphoshonate, a class of medicines that includes Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa, that was meant to prevent the loss of bone mass. In 1995, the FDA approved Fosamax to treat post-menopausal osteoporosis and Paget’s bone disease. Since 1995, more than 10 million patients have taken Fosamax or its generic equivalent, Alendronate. Unfortunately, to obtain FDA approval, Merck performed current clinical trials that lasted less than five years long. Widespread use of bisphosphonates, however, began to reveal serious problems, particularly among patients who used Fosamax for five years or more. The three most common serious side effects are femur fractures, osteonecrosis of the jaw, and esophageal cancer.
The FDA continues to investigate the safety and efficacy of Fosamax, and has already issued several warnings and revisions to the prescription drug’s label. In October 2010, the FDA issued a safety announcement regarding “the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis,” warning patients to be alert of an “dull or aching pain” in their hip or thigh and advising healthcare professionals to be alert to the increased risk of uncommon femoral shaft fractures.
An FDA staff report (PDF) noted that bisphosphonate drugs have no significant benefits beyond five years of use — the same period at which their risks increase dramatically — but the FDA advisory panels reviewing Fosamax have only recommended stronger warning labels, and have not recommended limiting Fosamax use to the first few years of treatment. Thus, Fosamax continues to be prescribed to patients who may actually be hurt, rather than helped, by the drug.
If you developed a non-traumatic fracture of the femur or bone decay in your jaw after taking Fosamax for several years, contact an attorney for a free, confidential consultation by using the form on the right or by calling my office at (215) 931-2634. You can also read more about our dangerous drug lawyers.