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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, and Actonel, made by Procter and Gamble, are taken by more than 36 million people, mostly post-menopausal women seeking to slow or prevent osteoporosis. Other brand names of the drug are Bonefos, Ostac, Didronel, Aredia and Skelid. 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.
If you or someone you know suffered serious jawbone injury because of the possible use of a bisphosphonate medication, you may want to contact a Fosamax attorney, Boniva attorney, Actonel attorney or Zometa attorney for a free evaluation of your case.
Professional organizations have issued warnings about the use of the oral versions of the drug -- namely Fosamax, Boniva and Actonel -- and the intravenous forms such as Zometa and the generic pamidronate. Some 191 prescription of the drugs have been written since 1995.
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.
Fosamax is Merck’s second best-selling drug, with 2005 revenues reaching a reported $3.2 billion. Fosamax and Actonel are the most commonly prescribed oral versions of the bisphosphonates, while Aredia and Zometa, made by Novartis, are used most in chemotherapy treatments. Novartis by June 2006 had reportedly said it had received reports of 2,500 cases of jawbone damage.
A recent study quoted by United Press International cited 2,400 patients who, since 2001, had suffered bone damage after taking the injected form of bisphosphonate, while 120 patients taking an oral form of the drug had been stricken with incapacitating bone, joint or muscle pain which in some cases left them bedridden or using walkers, crutches or wheelchairs.
While the medication supports 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.
Kline & Specter P.C., a firm based in Philadelphia with some 30 attorneys, several of whom are also highly skilled doctors, has had success litigating product liability and prescription drug lawsuits in Pennsylvania, New Jersey, Delaware and nationwide. Contact a Fosamax lawyer, Boniva lawyer, Actonel lawyer or Zometa lawyer today.
Note: Fosamax is commonly misspelled Fosomax.
Information Sources:
The Philadelpha Inquirer
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