Osteoporosis Drugs To Be Re-Evaluated By FDA Panel Amid Fracture Concerns

An X-ray of a fractured femur. An FDA advisory panel will meet Friday to re-evaluate the use of widely prescribed osteoporosis drugs amid concerns that their use can cause brittle bones and thigh fractures.

Osteoporosis drugs are to be re-evaluated by an FDA advisory panel on Friday amid concerns that their use can cause brittle bones.

The Food and Drug Administration advisory panel plans to make recommendations on whether the drugs' use should be limited to a few years, the WSJ reports.

They will also consider whether some women should temporarily stop treatment, a concept known as “a drug holiday.” The agency declined to comment ahead of the meeting.

Last year, the FDA recommended that doctors periodically re-evaluate the need for continued therapy in patients who have been on the drugs for more than five years, reports the WSJ.

Their recommendation arose from concerns about an unusual type of thigh, or femur, fracture seen in at least 300 women.

The drugs can slow the disintegration of bone caused by osteoporosis by partly blocking the body's natural process involved in removing and rebuilding bone tissue.

However, researchers speculate the products might also make the remaining bone brittle and susceptible to a rare type of thigh fracture and jaw-bone decay, the WSJ reports.

In 1995, Merck & Co.'s Fosamax became the first approved drug in a group of medications called bisphosphonates.

It was believed then that patients diagnosed with osteoporosis could be placed on the drugs indefinitely.

Hence, the drugs were approved and widely prescribed to women at risk of developing osteoporosis, often postmenopausal women in their 50s with low bone density, reports the WSJ. In 2005, Fosamax's sales peaked at $3.2 billion and generic versions of the medication are now available. Other commonly used drugs in the class include Actonel, marketed in the U.S. by Warner Chilcott PLC; Roche Holding AG’s Boniva; and Novartis AG's Reclast. The companies said their medicines were safe and effective for treating osteoporosis and they would continue to work with the FDA to better understand long-term side effects, the WSJ reports. Of the estimated 10 million people in the U.S. with osteoporosis, at least five million patients are on bisphosphonate therapy, according to the FDA. The disease largely affects women.
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