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New Warnings about Fosamax Side Effects Expected

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Denver, COThe US Food and Drug Administration (FDA) is expected to issue new warnings regarding Fosamax side effects later this month, according to reports. Those new warnings will likely concern the reported link between Fosamax and femur fractures as well as the potential for Fosamax osteonecrosis of the jaw. Despite the new warnings, and the reported link between Fosamax and serious side effects, the maker of Fosamax has so far won the majority of bellwether trials concerning the drug.

According to Fox News Denver (kdvr.com; 11/07/11), lawsuits have been filed in several states, including Colorado, alleging patients were not warned about serious side effects such as osteonecrosis of the jaw. Osteonecrosis of the jaw occurs when the patient's jawbone fails to heal after a minor trauma and the jawbone dies. Some experts say Fosamax and other bone-strengthening drugs can cause these serious side effects.

"(They can cause) osteoporosis of the jaw that has been reported with longer-term use and atypical fractures, which are fractures of the femur, or thigh bone," Sheryl Vondracek, associate professor at the University of Colorado, told Fox News. Meanwhile, cancer patients who have already weakened bones may be at an even more increased risk of atypical fractures.

Despite the opinion of some experts that Fosamax and other such medications are linked to an increased risk of osteonecrosis of the jaw and atypical fractures, Merck, maker of Fosamax, has so far won the majority of bellwether lawsuits to go to trial. Those bellwether cases, however, have focused on osteonecrosis of the jaw and not on allegations regarding femur fractures.

So far, Merck has won four of five trials to go before court, although a lawyer for the plaintiffs says he plans to appeal at least one of the verdicts. According to Reuters (10/31/11), Merck faces more than 1,600 Fosamax lawsuits in the US, with the next bellwether trial set for February 2012.

In September 2011, the FDA announced it was updating warnings on Fosamax at the recommendation of its advisory panels. The panels had met to discuss whether patients should be advised to take a "drug holiday" or stop using the medication after a certain time, but the panels did not agree with such recommendations. Prior to the meetings, the FDA issued a report that stated studies suggest no significant benefit to continuing bisphosphonate medications (a class of drug that includes Fosamax) past five years.

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READER COMMENTS

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I have been taking fossamax for much longer than 5 years with no negative results. It was prescribed because I have borderline Osteoporsis. I read one report that said to take a break from the drug rather than just stop using it.

How long of a break is reccomended, or should I just stop using it altogether. I have never had a broken bone except a toe about 20 years ago. I am 70 years old

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