Halted Fosamax Trial Re-Scheduled

We recently wrote that drug maker, Merck & Company, was scheduled to face its second round of Fosamax (alendronate) lawsuits in New Jersey over allegations that the bone drug causes femur fractures. The trial is scheduled to start next week and includes claims that the drug maker hid Fosamax risks.

The first trial ended in a mistrial last month in state court in Atlantic City, New Jersey, after the plaintiff suffered a “serious health complication” that was not related to her Fosamax use, Merck announced in a March 18 statement on its website, said Bloomberg News. The new trial is scheduled to begin in Trenton, New Jersey and is one of more than 3,300 brought against Merck over Fosamax. Another 1,230 cases, wrote Bloomberg News, allege users sustained jaw-related injuries, according to Merck. Patients have made two types of Fosamax injury claims: Femur fracture and jaw-related injuries.

Merck won approval for Fosamax in 1995 for treatment of bone loss due to osteoporosis and osteopenia. As we’ve explained, some bisphosphonates, like Fosamax, are approved to treat bone-weakening diseases like osteoporosis and Paget’s disease. Also, cancer patients often undergo therapy with bisphosphonate drugs to prevent fractures from bone metastases.

A recent study revealed that risks for developing osteonecrosis of the jaw (ONJ) following dental extractions raises significantly in patients taking bisphosphonate medications, when compared with patients not taking these medications. The study appeared in the International Journal of Oral and Maxillofacial Surgery.

In 2005, the U.S. Food & Drug Administration (FDA) ordered that warnings about ONJ be added to labels for Fosamax and other bisphosphonates. It is believed that osteonecrosis may develop when bisphosphonates prevent the body from repairing microscopic damage to the jawbone, such as what is seen during routine dental procedures.

Merck has been facing increased criticism since 2009 over Fosamax and allegations that taking the drug can cause a person to develop jawbone decay and, possibly, osteonecrosis of the jawbone. Bisphosphonates, as a class, are commonly prescribed to women experiencing menopause and are designed to prevent bone loss, one of the hallmark symptoms of menopause that could lead to bone fractures and other serious injuries.

While bisphosphonates have proven to be moderately successful at reducing bone loss in menopausal women, there are several dangerous drawbacks to the drugs, ironically each involves decay of bone or weakening of bones. Hundreds of women who claim they have taken Fosamax for long periods of time or at high doses have suffered from a weakening of their femur bone that has resulted in atypical fractures. While Fosamax was being taken to prevent bone loss, it was actually increasing the risk of a fracture of the bone considered one of the strongest in the body. An atypical femur fracture—which manifests as a subtrochanteric or diaphyseal fracture—may occur during normal everyday activities with little or no trauma.

The Archives of Internal Medicine recently published a study comparing patients with atypical versus “classic” femur fractures, reporting that 82 percent of patients in the atypical fracture category had taken bisphosphonates. The FDA has also recently published research about the risks and benefits of bisphosphonate therapy. According to its review of over 2,300 postmenopausal women, the agency stated that there was little reason to use Fosamax and its sister drugs for more than five years. The data was published in the New England Journal of Medicine last May.