In 2013, Merck & Co Inc agreed to pay $27.7 million to settle Fosamax cases. While these cases have been resolved, it is important to understand what caused the lawsuits to be filed.
Fosamax (alendronate) is a medication used to both prevent and treat osteoporosis in women and men. The purported benefits of the drug are the prevention of the loss of bone mass, to increase bone mass and to treat Paget’s disease of the bone.
Fosamax Side Effects
Some of the side effects that have been linked to Fosamax include:
- Osteonecrosis of the jaw or “dead jaw.” One of the more serious side effects—one not mentioned on the original drug warnings—is osteonecrosis of the jaw (ONJ). ONJ is a rare but debilitating jaw disorder that causes the jawbone to decay. Though the drug’s maker, Merck, has dismissed the link between Fosamax and ONJ, the FDA has acknowledged that in studies the drug does seem to increase the user’s risk of “dead jaw.” Those most at risk for this disorder include patients taking a bisphosphate, people with active dental disease, and those undergoing dental procedures. Though ONJ is not well understood, it is known that the disorder can cause lifelong pain and disfigurement.
- Femur fractures. A link has been made between Fosamax usage and fractures of the femur. These fractures occur during normal activities with no trauma.
- Irritation of the esophagus. The drug can cause the esophagus, or throat, to become damaged. Heartburn, pain when swallowing, pain in the center of the chest or trouble swallowing are all signs of damage and should be reported to your physician.
Other reported complications include muscle pain, joint pain, bone pain, and allergic reactions.
How Long Should Fosamax Be Used?
A study published in a May 2012 issue of the New England Journal of Medicine cautioned patients and their doctors to carefully consider long-term use of bisphosphonate drugs such as Fosamax. The study found little, if any, benefit to using these types of drugs for longer than three to five years. At the same time, the study found that the risk continues for rare but serious side effects.
While the Food and Drug Administration (FDA) stopped short of recommending that all patients discontinue Fosamax drugs after a certain amount of time, the FDA did encourage caution and individual risk assessments before continuing the drug for more than three to five years.
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