Federal drug regulators are suggesting that consumers consider limiting the use of popular osteoporosis medications, such as Fosamax, Actonel, Boniva and other bisphophonates, to between three and five years, allowing them to reduce the risk of side effects associated with long-term use of the medications while continuing to benefit from the medications after the use is stopped.
In a recently released web guide published by the FDA, the agency provides new guidance for individuals taking osteoporosis drugs, which have been linked to a risk of low-trauma femur fractures when they are used over long periods of time.
The new FDA consumer guide recommends a three to five year period of use should be considered, at least until more definitive data becomes available.
The five-year time limit was first suggested by a September 2011 FDA report, which noted that there appears to be no benefit to taking the drugs longer than five years. That report was issued before an FDA advisory committee was convened to review the risks associated with the long-term use of the medications. The panel ultimately voted to place stronger bone fracture label warnings on the popular medications, but did not go as far as finalizing any length-of-use recommendations.
“These drugs clearly work,” states Dr. Marcea Whitaker, an FDA medical officer and co-author of a recent Fosamax study. “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.”
Whitaker’s study, published last month in the New England Journal of Medicine, determined that there need to be more studies on how the drugs are affecting the bones to help doctors and the FDA make more concrete recommendations.
Fosamax, Actonel, Boniva and the other osteoporosis drugs are part of a class of medications known as bisphosphonates, which are used to reduce the risk of bone fractures associated with osteoporosis. However, concerns have emerged in recent years about side effects of Fosamax and the other drugs weakening the femur, resulting in atypical fractures that often occur with little or no trauma at all.
In October 2010, the FDA required new warnings about the risk of thigh fractures from Fosamax and other bisphosphonate medications. During a review of the potential health risk, the FDA determined that the risk of fractures of the thigh bone may be connected to long-term use of bisphosphonates.
Merck & Co. currently faces hundreds of Fosamax fracture lawsuits that have been filed by individuals who claim the drug maker failed to adequately warn about the potential risk of problems. Complaints allege that side effects of Fosamax may weaken the ability of the femur bone to repair itself from microdamage, increasing the risk of a sudden femur fracture.