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Patients, Doctors Must Be Warned About Risk of Spinal Fractures Soon After Stopping Osteoporosis Medication

Prolia’s Effects Are Short-Lived; Fractures Can Occur as Soon as a Month After Drug Wears Off

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must immediately require that stronger warnings be provided to doctors and patients about the increased risk of spinal fractures when patients stop taking the commonly used osteoporosis drug Prolia, Public Citizen said today in a petition to the agency.

Prolia, which is administered by injection every six months, was first approved by the FDA in 2010 to treat postmenopausal women with osteoporosis at high risk for fracture, but its use has since been expanded to include men. Its effects last six months. Public Citizen’s petition highlights a growing body of evidence showing that patients who stop using the drug have an increased risk of multiple vertebral fractures in the spine as soon as seven months after their last dose. Such fractures can cause severe, disabling pain.

Unlike other osteoporosis treatments, Prolia’s positive effects on bone are short-lived and readily reversible if the drug is discontinued. One study cited in the petition described 24 patients who collectively had experienced 112 new spinal fractures, which represents an average of nearly five fractures per patient.

The petition asks the FDA to upgrade the warning about this risk, which is buried deep in the label, by replacing it with a more prominent black box warning at the top of the product labeling, the strongest warning that the agency can require. The petition also asks the FDA to require Amgen, the maker of Prolia, to send letters to doctors and develop updated patient brochures that warn about the increased risk of spinal fractures if the medication is stopped or a scheduled dose is missed.

“It is critical that the FDA require a black box warning to ensure that doctors are fully aware of the risks involved with stopping Prolia,” said Meena Aladdin, health researcher at Public Citizen’s Health Research Group. “Patients should be given a patient brochure every time they receive a dose of Prolia that explicitly warns them about the risk of spinal fractures if they stop taking the medication and don’t receive alternative osteoporosis therapy to mitigate this risk.”

Read the petition.