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Fosamax and Men - Risks and Warnings
With the recent bombshell that Fosamax, Merck & Co.'s second best-selling drug, causes bone death (also known as osteonecrosis [ONJ] or dead jaw syndrome) of the jaw in some patients, the osteoporosis and cancer treatments of a large group of women have been called into question. But a smaller group of Fosamax users is also at risk - the thousands of men who use Fosamax and Fosamax D to increase bone mass due to a number of medical conditions.
Male Indications for Fosamax
Fosamax, a bisphosphonate that increases bone mass in weak-boned patients, is primarily prescribed to post-menopausal women suffering from osteoporosis or bone loss attributed to cancer. However, the drug, which is available in tablet or liquid form, is also indicated to male patients suffering from a variety of ailments such as prostate cancer and male osteoporosis. The anti-androgen treatment common to prostate cancer can cause decreased bone density and a higher risk of fractures. Some men have osteoporosis caused by repeated exposure to steroid medications such as prednisone; Fosamax has been approved for use in male patients.
Male Patients May Be At Risk for Adverse Fosamax Side Effects
Fosamax has been marketed by Merck as a miracle drug that can increase bone mass and prevent bone loss. However, recent events have uncovered that in some patients, the drug actually decreases bone health by causing osteonecrosis, or bone death, in the jaw. ONJ is an irreversible condition that causes the bone to rot in the jaw. It may require extensive oral surgery, long-term antibiotic treatment, and causes painful swelling and loose teeth. ONJ is more likely in cancer patients who are taking the powerful liquid form of Fosamax; however, it has been noted in patients taking the tablet form, as well.
While Merck has denied that its testing ever revealed a single case of ONJ, doctors and oral surgeons around the country are speaking out against the painful side effects of Fosamax. Particular complaints have been raised by the Journal of Oral and Maxillofacial Surgeons, which published a study linking Fosamax to ONJ and bone death in 2004, and The American Association of Endodontists, which recently published a position paper stating that all Fosamax patients may be at risk for ONJ. Pressure from these organizations and other doctors forced the Food and Drug Administration to require Merck to place warning labels on bottles of Fosamax as early as 2004, but a recent lawsuit alleges that Merck has not followed that recommendation and has insufficiently labeled Fosamax bottles.
Class Action Lawsuit - Is Merck Guilty of Criminal Negligence With Fosamax?
Public outcry by physicians and professional associations was just the start of Merck's Fosamax troubles. In 2006, the FDA reported that actual deaths had occurred from osteonecrosis related to Fosamax use. And in spring 2006, a class action lawsuit was filed in Fort Meyers, Florida. The Fosamax class action suit (and the inevitable lawsuits that will follow) alleges that Merck used deceptive labeling practices and was criminally negligent in its marketing of an unsafe drug with adverse side effects. If you are taking Fosamax or Fosamax D or did in the past, consult your doctor about whether to continue, and look into legal representation. An experienced products liability lawyer or class action attorney can help evaluate your case and tell you whether you qualify for monetary damages for your Fosamax use.
