FDA says Osteoporosis Drug Labels Must Warn Patients of Risk of Leg Fractures

October 13, 2010

The U.S. Food and Drug Administration (FDA) announced today that the agency is requiring the labels of bisphosphonate osteoporosis drugs Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia and Reclast (and their generic products) to include a warning about increased risk of fracture of the thigh bone.

Doctors prescribe these bisphosphonates for the prevention or slowing of bone loss, or osteoporosis, in postmenopausal women. Prescriptions for bisphosphonates in the U.S. number more than 5 million yearly.

Patients taking bisphosphonates have reported leg fractures including atypical subtrochanteric femur fractures, fractures in the bone just below the hip joint, and diaphyseal femur fractures in the long part of the thigh bone. Patients who suffered fractures also reported hip or thigh pain in the months preceding the fracture. The FDA says that it is unclear whether bisphosphonates are the cause. However, patients taking the osteoporosis drugs are the predominant the victims of unusual femur fractures. These atypical fractures may be related to long-term term bisphosphonate use.

In March, the FDA issued a notice that it was investigating the potential risk of atypical bone fractures and working with the American Society of Bone and Mineral Research.

In addition to the new labeling requirements, the drug manufacturer must give patients taking bisphosphonates a medication guide that warns of the risks of leg fractures, describes the symptoms of atypical femur fracture and recommends that patients notify their healthcare professional if they develop symptoms.

The FDA recommends that if you currently take a bisphosphonate, you should:

• Continue to take your medication unless you are told to stop by your healthcare professional.
• Talk to your healthcare 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 FDA’s MedWatch program

This notice does not affect bisphosphonate drugs that only are used to treat Paget’s disease or high blood calcium levels due to cancer (i.e., Didronel, Zometa, Skelid, and their generic products).

A study released in September 2010 found that people who take bisphosphonates such as Actonel, Boniva and Fosamax for more than five years might have double the risk of developing cancer of the esophagus.