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FDA Reviewing Possible New Fosamax Side Effects

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Washington, DCThe US Food and Drug Administration is currently examining oral bone medicines based on new evidence of Fosamax side effects such as esophageal cancer, according to Bloomberg.

The news source reports that the FDA announced recently that it plans to hold a meeting with agency advisers on September 9 to discuss the safety of osteoporosis drugs such as Merck's Fosamax. The agency is reportedly in the process of reviewing studies in the UK that demonstrated conflicting results as to whether or not the drugs increase the risk of throat cancer.

The meeting of the advisers will likely prove crucial, as more than 40 million people in the US either suffer from osteoporosis or have an increased risk of the disease due to low bone mass, the National Institutes of Health reported, according to the news source.

According to the Institutes, osteoporosis makes bones weak and more likely to break. The condition is more common in older women, with risk factors including aging, family history, small stature and taking certain medications.

While the FDA is reviewing studies about the potential risks of such medications, the agency noted that at this point, the "benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks," according to the news source.

Such bisphosphonate drugs include Roche's Boniva and Merck's Fosamax, which have been the subject of a number of lawsuits in recent years due to serious side effects that include rare fractures.

In one of the most recent lawsuits involving Fosamax, a woman from Hawaii sued Merck after she allegedly suffered a thigh bone fracture that she claims occurred because she took the drug for eight years. The retired high school teacher claimed she suffered the fracture when she simply took a step backwards, according to the Honolulu Star-Advertiser.

According to the National Center for Biotechnology Information, Fosamax comes as either a tablet or solution that is taken orally. In addition to reports of increased fracture risks associated with the drug, the NCBI says some more common side effects of Fosamax can include stomach pain, nausea, changes in the ability to taste food, difficulty swallowing or poor healing of the jaw.


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