Federal agency warns of possible fracture risk with osteoporosis drugs

Consumers, mostly women, who take bisphosphonates to treat osteoporosis are at possible risk of a rare type of thighbone fracture.

The Food and Drug Administration is warning patients and health care professionals of the risk, because the rare type of fracture has been mainly reported in patients taking these prescription medications.

The possible risk of thigh fracture will be added to the label for bisphosphonate medications and a medication guide that will be given to patients when they pick up their prescription, the FDA says.

Bisphosphonates are a class of drugs that slow or inhibit the loss of bone mass. They’ve been used since 1995 to prevent and treat osteoporosis and similar diseases.

It’s not clear whether bisphosphonates are the cause of the unusual bone breaks, which occur just below the hip joint or on the long part of the thigh, according to the FDA.

Medication guide and labeling change

The changes will occur for the following drugs:

• Oral bisphosphonates such as Actonel, Actonel with Calcium, Atelvia, Boniva, Fosamax, Fosamax Plus D, and their generic products.

• Injectable bisphosphonates such as Boniva and Reclast and their generic products.

The FDA says the optimal duration of bisphosphonates treatment for osteoporosis is unknown – an uncertainty the agency is highlighting because these fractures may be related to use of bisphosphonates for longer than five years.

The agency continues to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment, FDA medical officer Theresa Kehoe, M.D., says.

Advice for consumers

If you’re currently taking bisphosphonates for osteoporosis, the FDA advises that you:

• Keep taking your medication unless you are told to stop by your health care professional.

• Read the medication guide. It will describe the symptoms of thighbone fractures. The guide also advises you to notify your health care professional if you develop symptoms.

• Tell your health care professional if you develop new hip or thigh pain (commonly described as dull or aching pain), or have any concerns with your medications.

• Report any side effects with your bisphosphonate medication to the FDA's MedWatch program: online, by mail using postage-paid, pre-addressed FDA form 35004, by Fax at 800-FDA-0178, or by phone at 800-FDA-1088.

The FDA also recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued medication, especially for patients who have been on it for longer than five years.