Osteoporosis Drug Labels Should Show Long-Term Risks

September 2011

The Food and Drug Administration (FDA) is questioning the safety of the osteoporosis drugs Fosamax, Boniva, Actonel, and Reclast, and has suggested the labels be updated to reflect the potential health risk of taking the medications long-term.

The four drugs are called bisphosphonates and are used to treat women who suffer from bone loss due to menopause. More than 5 million prescriptions of bisphosphonates were filled in 2009.

In October 2010, the FDA updated the label for Fosamax to warn users about the risk of abnormal fractures of the thigh. Many patients who had taken the drug for a long time suffered from femur fractures while doing normal activities, such as getting out of bed. More health risks include osteonecrosis of the jaw, esophageal cancer, and most recently kidney failure (in an alert released on September 1, 2011).

Several bisphosphonates were affected by the notice, including Fosamax+D, Actonel, Actonal+Ca, Boniva, Atelvia, and Reclast.

Now, the FDA is saying the drug labels should tell users how long to use each medication. Dr. Elizabeth Shane, a former president of the American Society for Bone and Mineral Research, suggests that the drugs should only be prescribed to those at very high risk for fractures due to osteoporosis.

Patients should not stop taking any prescription medication without consulting a healthcare professional first. Doing so can cause serious medical complications.

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