FDA Says Some Osteoporosis Drugs Have Possible Fracture Risks | Shapiro, Washburn & Sharp

The Food and Drug Administration (FDA) issued a warning on Wednesday, Oct. 13, about a possible risk of two rare types of thigh fractures in people who take bisphosphonates, a class of osteoporosis drugs that includes Fosamax and Boniva.

Bisphosphonates work by slowing the loss of bone cells that lead to osteoporosis. Many studies suggest an overall benefit from taking the medication for women who are at risk for osteoporosis. In fact, bisphosphonates can help prevent hip and spine fractures, which for many women may lead to death. However, many doctors have reported an opposite effect for numerous people taking the drug. Fosamax has already been linked to severe musculoskeletal pain, as well as to a serious bone-related jaw disease called osteonecrosis.

According to the FDA, bisphosphonate labels are being updated to describe the risk of the two atypical fractures of the thigh. They are known as subtrochanteric femur fractures, which occur just below the hip joint, and diaphyseal femur fractures, which occur in the long part of the thigh. Since these unusual fractures may be related to long-term bisphosphonate use, the agency will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs. The statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis. In addition, the FDA is requiring that patients be given a Medication Guide that describes the symptoms of atypical fractures and recommends that patients notify their healthcare professional if they develop symptoms.


The changes to labeling and the medication guide will affect only bisphosphonates approved for osteoporosis. Prescription drugs in that class include Merck & Co.’s Fosamax and Roche’s Boniva, as well as Procter & Gamble Co.’s Actonel, Warner Chilcott’s Atelvia and Novartis’ Reclast.


In 2008, the FDA contacted the pharmaceutical company Merck about the reports of femur fractures. After 16 months, Merck managed to add patients’ reports of femur fractures to the list of possible side effects reported by patients included in the drug’s package insert. Merck defended its product Fosamax, which was the first bisphosphonate and is still the most frequently prescribed. A Merck spokesman, Ron Rogers, said the company did not find any increased risk of fractures in clinical studies with more than 28,000 patients.


Genentech, the Roche subsidiary that sells Boniva in the United States, will add a statement to Boniva labels warning of the possible increased fracture risk, according to Terry Hurley, spokesman for Genentech. “Boniva has been studied extensively in clinical trials and more than 20 million patients have been treated worldwide since the monthly medicine was approved in 2005,” Mr. Hurley said Wednesday.


The FDA said it will work closely with outside experts, including members of the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information. A study conducted by the group of more than 300 cases of such fractures found that 94 percent of the patients had taken bisphosphonates, and most had been on the drugs for five years or more. The study also found that more than half of the studied patients experienced groin or thigh pain for a period of weeks or months before their fractures.


The FDA’s Advice for Patients

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


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 bisphosphonate therapy, particularly for patients who have been on bisphosphonates for longer than five years.  Dr. Theresa Kehoe, an F.D.A. osteoporosis expert, said the agency is continuing to evaluate the safety and effectiveness of bisphosphonates when used for long periods.

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