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.
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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.