FDA Cautions Against Long Term Fosamax Use

The U.S. Food and Drug Administration (FDA) announced on Wednesday, May 9, that patients taking the osteoporosis drug, Fosamax, or any of the bone-building class of drugs known as bisphosphonates, should be reevaluated every three to five years to determine if it is safe for them to remain on the drugs.

Bisphosphonates include drugs such as Actonel, Boniva, Fosamax, Reclast, and Zometa. These are among the most commonly prescribed to patients who have been diagnosed with the bone-thinning condition osteoporosis or its precursor, osteopenia.

They work by slowing cells responsible for the natural cycle of bone breakdown called resorption. As a result however, a patient may be left with old bone that would normally breakdown then be reformed as part of the normal lifetime cycle of bone. Messing with the natural cycles through the long-term use of bisphosphonates may actually leave bones weaker causing atypical femur fractures, osteonecrosis or a weakening of the jaw, and esophageal cancer. These are rare but serious adverse events.

The FDA review, “Bisphosphonates for Osteoporosis – Where Do We Go from Here?” published in the New England Journal of Medicine found that Fosamax offered little if any benefits after long-term use of three to five years. And the downside may not be worth the risk. Researchers estimated that up to 70 percent of users could come off the drugs after three to five years, particularly those women who have been diagnosed with the less serious osteopenia.

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The American Society for Bone and Mineral Research (ASBMR) is on record saying the benefits of this class of drugs still outweigh the risks, but it adds that each individual patient should be evaluated on a case-by-case basis.  Stopping the drug might not be the best option either, the group concludes, and more research is critically needed to guide doctors and their patients about what to expect when someone discontinues the long-term treatment.

According to a May article in the Journal of Bone and Mineral Research, when bisphosphonate use is discontinued there is a gradual reduction in bone turnover markers and a slow return to pretreatment levels within three to 60 months.

As it’s been two years since the FDA notified the public about atypical femur fractures associated with this class of drugs, 400 lawsuits have been filed in federal court in New Jersey and about 2,000 individual cases have been filed.

With more than 150 million prescriptions dispensed to treat osteoporosis between 2005 and 2009, one in two women and one in four men over the age of 50 need answers now whether the treatment is worse than the disease.  The answers are long overdue for the 10 million Americans with osteoporosis and another 34 million at risk for it.