FDA Says More Studies Needed For Osteoporosis Drug

The FDA says that more research is necessary for bisphosphonates, which are a class of drugs used to treat patients with osteoporosis. Bisphosphonates have been used since 1995 to treat patients with osteoporosis, and it is estimated that as many as 44 million Americans are at risk for the condition. While the drugs have proven effective, regulators are looking into the long term effects of regular usage of the drugs.

Dr. Marcea Whitaker, co-author of the bisphosphonates review and a medical officer at the FDA, says that more information is needed in order to determine the appropriate amount of time patients should be taking the drug. “These drugs clearly work. We just don't know yet the optimum period of time individual patients should be on the drug to both maximize its effectiveness and minimize potential risks,” said Dr. Whitaker.

The FDA’s own review of bisphosphonate looked at the effects of long term usage of the drug. . The FDA’s research was published in 2012 in the New England Journal of Medicine. While the FDA’s review of clinical studies determined that some patients could stop using the drug after 3-5 years of treatment and continue to get the drugs’ benefits it also stated that more research was necessary for bisphosphonate drugs. Brand name bisphosphonates on the market today include Actonel, Atelvia, Boniva, and Fosamax.

Whitaker said that the researchers were still looking into whether patients have significantly lower fracture rates after taking the drug for a prolonged period, and if younger patients could have shorter treatment lengths. There are also potential risks of bisphosphonates use that the FDA is investigating, including significant jaw bone decay and a link between bisphosphonates use and esophageal cancer. Some patients using bisphosphonates have also gotten “unusual” thigh bone fractures. As a result of these potential risks, the FDA is continuing to look at the long term effectiveness of bisphosphonates.