FDA warns public about chance of pain from bisphosphonates

WASHINGTON The Food and Drug Administration has issued a warning to health care professionals and patients regarding the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates.

The drugs in this class of drugs include: Actonel, Actonel+Ca, Aredia, Boniva, Fosamax, Fosamax+D, Reclast, Skelid and Zometa. Severe muscle pain is included in the prescribing information for all bisphosphonates, but it may be overlooked by health care professionals leading to the use of analgesics to resolve the problem.

The severe musculoskeletal pain may occur within days, months or years after starting bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution.

The FDA is warning health care professionals to consider whether to temporarily or permanently discontinue prescribing the drugs to their patients.