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Popular osteoporosis drugs known as bisphosphonates – whose brand names include Fosamax, Boniva, Actonel, Zometa and others – are believed to be linked to osteonecrosis, a serious and irreversible disease that causes jawbone decay.
Osteonecrosis of the jaw, also known as ONJ or jawbone tissue death, causes a patient’s jawbone to rot and die, requiring long-term antibiotic therapy or surgery to remove dying bone tissue.
Bisphosphonates such as Fosamax, manufactured by Merck, are taken mostly by post-menopausal women seeking to slow or prevent osteoporosis. The medication, which is generally prescribed in pill form but is also administered intravenously, is also used to treat certain cancers and Paget’s disease.
Symptoms of osteonecrosis include burning, tingling or localized pain or swelling in the jaw, infection (possibly with pus), and irregular sores with exposed bone.
Kline & Specter, P.C., handled cases involving bisphosphonates such as Fosamax and Boniva after professional organizations issued warnings about their use.
The American Association of Endodontists, whose members specialize in root canal procedures, issued a position statement on March 30, 2006 about the use of bisphosphonates. The AAE said reports suggested that problems with jawbone tissue death may be triggered by tooth extractions and other dental surgeries. However, the ailment can also occur "out of the blue," as a June 2006 article in The Philadelphia Inquirer put it. (See articles below.)
In 2004, a connection between bisphosphonates and osteonecrosis was found by doctors at Long Island Jewish Medical Center. The findings, reported in the Journal of Oral and Maxillofacial Surgeons, prompted the U.S. Food and Drug Administration to issue a warning to healthcare professionals.
In July 2005, at the request of the FDA, Merck added a warning notice to the label of Fosamax, which had been approved by the FDA in 1995. However, critics claim the warning was obscured, appearing only on page 13 of a 22-page document provided to pharmacies.
On April 10, 2006, a lawsuit was filed in federal court claiming that Fosamax is a defective product because it can cause osteonecrosis or jawbone tissue death and alleging Merck concealed the drug’s dangerous side effects from patients and doctors. New Jersey-based Merck is already facing thousands of lawsuits over another drug, Vioxx, which was withdrawn from the market in September 2004.
While the bisphosphonate medications support the buildup of bone in areas weakened by disease, one side effect is thought to be the opposite effect – a weakening of the bone – in the upper and lower jawbones.