Fosamax has been named in a lawsuit filed by a Connecticut woman who claims the osteoporosis drug caused multiple stress fractures and suppressed bone regeneration in her legs. JoAnn Moranski, who took Fosamax for 10 years, is just the latest plaintiff to file suit against Merck as a result of health problems caused by the medication. Another 400 plaintiffs have Fosamax lawsuits pending that allege the bone medication caused a bone-wasting condition known as osteonecrosis of the jaw (ONJ).
Fosamax, a popular osteoporosis drug, has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues. One of the most serious is its association with ONJ. In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition. ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.
Hundreds of patients have sued Merck, claiming that their ONJ was caused by Fosamax. Earlier this month, a federal judge refused to grant class action status to a group of ONJ lawsuit plaintiffs in Pennsylvania, Florida and Louisiana who wanted Merck to establish a Fosamax medical monitoring fund. Because of the judge’s decision in this matter, it is expected that the number of Fosamax Dead Jaw Syndrome lawsuits currently making their way through the courts is likely to explode.
But ONJ isn’t the only problem associated with Fosamax. Just a few weeks ago, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.
Despite its safety problems, Fosamax netted Merck sales of nearly $3 billion in 2007. But the company’s patent protection on Fosamax runs out next month, meaning cheaper generic versions of the drug could soon cut into Merck’s sales.