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Fosamax, also known by the generic name Alendronat, is a prescription drug manufactured by Merck & Co. It received Food and Drug Administration (FDA) approval in 1995 and became a blockbuster drug with 2005 sales in excess of $3 Billion Dollars generated by more than 22 million recorded prescriptions. Fosomax is a type of drug known as a bisphosphonate, which is prescribed to increase bone mass and reduce the likelihood of bone fractures. It is primarily used for the treatment of osteoporosis, a condition resulting in the loss of bone density, and Paget’s Disease, where a break down in bone tissue occurs with resulting abnormal bone reformation. It can be administered either orally or intravenously.
Despite the lenght of time on the market, an article published in the Journal of Oral and Maxillofacial Surgeons in March of 2004 revealed that Fosomax side effects include Osteonecrosis or ONJ, an irreversible and painful condition where the jawbone fails to heal and dies. The article confirmed reports dating back to 2001 from oral surgeons and dentists that bisphosphonates were a contributing cause of jaw bone decay. As a result of these findings the FDA, in September 2004, required all bisphosphonates to include warnings concerning osteonecrosis. While others promptly complied, Merck failed to do so on its Fosamax label. This is particularly disturbing because while numerous companies make bisphosphonates, an FDA review indicated a much higher incidence of ONJ with Fosomax.
Symptoms of ONJ include:
These symptoms can develop at the site of minor traumas, prior tooth extractions and even in otherwise undisturbed jawbone structures. Treatment frequently involves long-term antibiotic therapy, surgery to remove bone tissue and in extreme cases, reconstruction of the jaw. Inasmuch as bisphosphonates are used to treat osteoporosis in post-menopausal women and patients with metastasized cancer in their bone tissue, millions of users have been exposed to the possibility of developing ONJ. Furthermore, bisphophonates are not metabolized and can remain in the body in high concentrations for many months after use is stopped. Because of this fact, those taking Fosamax should avoid all tooth extractions, or any other major dental work, until well after discontinuing use of the drug.
Have you or a loved one suffered Fosamax side effects?
At Oshman & Mirisola our experienced Fosomax attoneys will provide you with aggressive representation in the handling of your case. If you or a loved one suffered a serious injury that may have been caused by this drug, including related Fosamax ONJ or related Fosamax osteonecrosis, call or contact us to represent your interests in a Fosomax lawsuit. We offer a FREE, no-obligation consultation with a Fosomax lawyer so that you can learn more about your legal rights and options.