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FDA panel fails to agree on Bisphosphonate Drug Restrictions

South Carolina Fosamax Lawsuit

Reproductive Health Drugs and the Drug Safety and Risk Management Advisory board met last week to determine whether the U.S. Food and Drug Administration (FDA) should require drug companies to change the label on bisphosphonate drugs to warn that the drug not be used long term.

Read about one bisphosphonate drug Fosamax and its dangers.

While the advisory panel did agree to increase warnings on the drugs, the conformity ended there. Once faced with next question of whether the labels should “further clarify the duration of use” of the drugs, the advisory meeting ended in a 17-6 vote.

The FDA claimed that the studies show the drugs provide benefits in preventing osteoporosis fractures for the first three years of treatment; but there isn’t any information indicating such benefits associated with taking the medication beyond five years.

Fosamax Lawsuit

In addition, the studies also showed that women who stop taking the medication after five years have similar levels of increased bone density and reduced fracture risk as those who continue taking them.

As a result, the FDA considered whether some patients should take a break or “drug holiday” after using the medication for three to five years.  However, they then agreed that there was not enough information to efficiently make that recommendation.

Biphosphonate drugs, including:

  • Fosamax,
  • Actonel,
  • Boniva, and
  • Reclast,

treat postmenopausal osteoporosis, as well as osteopenia, a pre-osteoporosis condition. These drugs have come under severe scrutiny because of studies that found they have been linked to osteonecrosis of the jaw (jaw death) and femur fractures (broken thigh bone) with long-term use.

In 2010 Merck & Co., the manufacturer of Fosamax, added the warning of the risk of femur fractures.

By:South CarolinaPersonal Injury Lawyer Pete Strom



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