The labeling changes will affect all bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and generics and injectable bisphosphonates such as Reclast and Boniva.
However, labeling changes will not apply to bisphosphonates used for Paget's disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic versions, the agency said.
This warning comes after the agency announced in March that there was an ongoing safety review of bisphosphonates and their association with atypical femur fractures.
Since then, the FDA has reviewed all available information on this connection, including 310 cases of atypical thigh fractures. In that review, 94 percent of the patients had taken bisphosphonates, and most had been on the drugs for five years or more.
However, these fractures are so unusual that they make up less than 1 percent of all hip and thigh fractures.
Based on that review, the agency is changing the Warnings and Precautions label section of all bisphosphonate products for osteoporosis and requiring a medication guide that will caution patients of the possible increased risk of fracture.
The agency also recommends that doctors and other health care professionals be aware of the potential risk in patients taking these drugs and consider re-evaluating the need for continued use of these drugs for patients who have been taking them for more than five years.
The agency also recommends that physicians discontinue bisphosphonates if patients develop a femoral shaft fracture.
For patients currently taking bisphosphonates for osteoporosis, the FDA recommends not discontinuing them without talking to their doctor.
In addition, patients taking bisphosphonates should report any new thigh or groin pain
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