Fosamax, other osteoporosis drugs to be discussed by FDA panel

According to a Wall Street Journal report this week, osteoporosis drug Fosamax and similar products are going to be discussed by an FDA panel this summer. The panel will meet in September to go over the long term safety of the drugs.

The class of medications is known as bisphosphonates and has been tied to multiple thigh fractures and jaw problems when used for long periods of time. Aside from Fosamax, the report states that other drugs under review will include Actonel, Boniva, and Reclast.

The article states that bisphosphonates are currently being used by nearly 5 million Americans. In the past these drugs have been praised for their ability to build up bone mass, while cutting down the development of osteoporosis, but recent reports have tarnished the drug’s reputation. According to the WSJ report, there have been over 300 previous cases of femur fractures with patients who are taking Fosamax. In most cases, these patients have taken the drug for over five years.

The article claims that the FDA is not making a firm statement on the drug at this time. It says the FDA is claiming that it’s not clear whether the drugs were the cause of long term susceptibility, bone damage and fractures.

Although the FDA is staying mum currently, they did issue some news on Fosamax in 2010. They released warnings which mentioned the risk of fractures related to long term use of Fosamax. Since the FDA issued this original release, Fosamax and its manufacturer have been the focus of a growing number of lawsuits.

According to multiple other news reports this week, a Hawaii woman with osteoporosis sued the drug maker after breaking a thigh bone. The suit called out Fosamax distributor Merck & Co. in claiming that the drug has the opposite effects of what it’s intended to do. The woman claimed the osteoporosis drug made bones more brittle over time, rather than strengthening them.

In June, numerous Fosamax lawsuits were consolidated in the District Court of New Jersey. The decision included 37 separate cases that were pending throughout district courts all over the nation. There are also nearly a 1000 lawsuits involving Fosamax in New York alone involving jaw problems, as the source of another multi district lawsuit.

References:

Consillio, Kristen. (June 30, 2011). “Isle woman sues drugmaker after breaking thigh bone.” Retrieved on July 11, 2011 from the Honolulu Star

Corbett, Jennifer. (July 8, 2011). “FDA Panel to Discuss Safety Of Osteoporosis Drugs.” Retrieved on July 11, 2011 from the Wall Street Journal