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FDA Investigates Risk of Long-Term Use of Osteoporosis Drugs

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May 11, 2012 — The U.S. Food and Drug Administration (FDA) has recently taken an unusual step to publish a study in the New England Journal of Medicine regarding the dangerous of long-term use of bisphosphonates. These popular osteoporosis drugs include Actonel, Atelvia, Boniva, and Fosamax. In short, the study warned that after five years, the risks of using these medications may outweigh their risks.

Evidence that been growing that the long-term use of these drugs is associated with an increased risk of osteonecrosis (bone death in the jaw), unusual bone fractures in the femur, and esophageal cancer. Women who have taken the drugs for several years have the highest risk of suffering this severe side effect.

In September 2011, an independent FDA advisory panel voted to recommend that the labels on all bisphosphonate drugs be updated to include additional warnings about the risks of long-term use. Even so, the committee agreed that there is no conclusive scientific data to support a regulatory restriction on the duration of using the drugs.

In the New England Journal of Medicine study, the FDA warned that additional studies are “crucial.” The label currently has an “Important Limitation of Use” statement, which reads: “The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.”

Although studies have shown that bisphosphonate drugs are beneficial for treating osteoporosis for approximately three years, there is little information for longer than three years. Therefore, the FDA decided to do its own investigation of side effects in existing long-term safety studies that were conducted for at least three years.

The FDA recommends that studies need to be conducted to determine how long the anti-osteoporosis effects of bisphosphonate drugs last after the drug is discontinued. The FDA also recommends that scientists need to create criteria to test long-term users of bisphosphonate drugs to determine whether they are at risk of bone fractures or other severe side effects.

The FDA concluded their analysis by recommending that younger patients are good candidates for discontinuing bisphosphonate drugs after 3-5 years, but older patients should probably be kept on the drugs. Furthermore, physicians should exercise caution when switching a patient between different bisphosphonate drugs.

 

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