FDA issues MedWatch alert on pain risks of bisphosphonates

Physicians are urged to consider whether the drugs might be responsible for severe musculoskeletal pain and perhaps to discontinue use among patients with that symptom.

By Susan J. Landers, AMNews staff. Jan. 28, 2008.

Washington -- Physicians were warned by the Food and Drug Administration to be alert for severe and sometimes incapacitating bone, joint and/or muscle pain among patients taking bisphosphonates, the popular osteoporosis treatment.

The agency issued the alarm in a Jan. 7 MedWatch alert.

Warnings for severe musculoskeletal pain already are included in label information for all bisphosphonates, but the association may be overlooked by physicians, the FDA said. Pain may begin days, months or even years after starting the drug. Bisphosphonates, which slow bone loss, have been in use for about a decade.

Some patients reported complete relief of symptoms after discontinuing the medication, while others reported slow or incomplete recovery, said the agency.

This pain warning joins cautions that fever, chills, bone pain, myalgias and arthralgias may affect some patients when they begin taking bisphosphonates either intravenously or orally on a weekly or monthly basis, the FDA said.

Each year, more than 1.5 million fractures are believed to be caused by osteoporosis, according to the National Osteoporosis Foundation, making treatment of the condition a common focus of primary care.

Nevertheless, physicians were urged to consider whether the drugs might be responsible for severe musculoskeletal pain in patients and to perhaps discontinue the drug temporarily or permanently in cases in which the drug is thought to be the cause.