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FDA announces investigation into Fosamax side effects risk |
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Tuesday, 02 October 2007 |
The Food and Drug Administration has announced that it will conduct a one year safety review of Fosamax and other similar drugs to investigate their risk of causing an irregular heartbeat. Fosamax is part of a class of drugs known as bisphosphonates, which are designed to treat osteoporosis, Paget’s disease and bone problems caused by advanced cancer.
The agency’s investigation into the risk of Fosamax side effects was prompted by an article published in the New England Journal of Medicine earlier this year, which found that women taking Fosamax were at an increased risk of developing an irregular heartbeat. After reviewing a 1997 study of women on Fosamax, researchers concluded that patients taking the drug were 50% more likely to develop an irregular heartbeat than those not taking it.
In a second study published in the same issue, researchers also found that women taking another bisphosphonate drug were more than twice as likely to develop an irregular heartbeat than other patients.
Although a potential link between Fosamax and irregular heartbeats was only discovered within the past year, concerns about the risk of Fosamax side effects existed well before the NEJM study. Fosamax has also been linked with a painful condition known as osteonecrosis of the jaw, or jaw necrosis. This condition can cause the death of jawbone tissue, leading to extreme pain and, in some cases, the need to remove the jaw.
A number of patients who developed osteonecrosis of the jaw after taking the drug have filed Fosamax lawsuits against the drug’s manufacturer, alleging that they were not fully warned about the risk of Fosamax side effects before they began taking it. |