No Longer Accepting Cases

May 11, 2012 — The U.S. Food and Drug Administration (FDA) has recently published an article in the New England Journal of Medicine regarding an analysis of the risks of long-term use of bisphosphonate osteoporosis drugs.

In an unusual move for the administration, health experts reviewed the existing long-term safety studies and made suggestions for studies that should be conducted in the future to better understand the risk.

Bisphosphonate osteoporosis drugs include Fosamax, Actonel, Boniva, and Atelvia. These drugs are used by millions of people to slow bone-loss associated with osteoporosis. Unfortunately, the FDA has received numerous reports of severe adverse events. Side effects of bisphosphonate drugs includes esophageal cancer, bone deterioration in the jaw (osteonecrosis), and bone fractures (especially in the femur). Older women seem to have the highest risk of suffering these severe side effects.

All studies have determined that bisphosphonate drugs are effective at treating osteoporosis, with greater benefit than risk for approximately 3-5 years. However, there is very little scientific information regarding their long-term use, especially beyond five years.

In September 2011, an independent FDA committee investigated the issue and voted to update the warnings on all bisphosphonate drugs to warn patients about the potential long-term health risks. However, they voted against regulator action to restrict long-term sales of the drugs, because the scientific evidence is still inconclusive.

Currently, the labels on bisphosphonate drugs carry an “Important Limitation of Use” warning. The statement 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.”

However, there is no clear criteria for this re-evaluation. The FDA concluded their analysis by recommending that scientists create a way to determine whether a patient can safely use a bisphosphonate drug for longer than five years. They suggested that younger patients likely should not use the drugs for long periods of time, but for older patients, the benefits may outweigh the risks.

It is unknown exactly what the risks are, however, or who specifically has the greatest risk. The FDA analysis specifically looked at long-term safety studies, and concluded that bisphosphonate drug use longer than five years is associated with an increased risk of side effects. They cautioned physicians against switching a patient between drugs, and recommended that a study be conducted to determine how long the benefits of bisphosphonate drugs last after the drug is discontinued.

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