FDA warns of bisphosphonates fracture risk
pharmafile | October 20, 2010 | News story | Sales and Marketing | Boniva, Fosamax, Reclast, actonel, bisphosphonates, osteoporosis
The FDA has ordered a label change for a number of osteoporosis drugs after concerns their long-term use raises the risk of atypical thigh bone fracture.
Currently the optimal duration of bisphosphonate use for osteoporosis is unknown, and the US regulator says it is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.
The bisphosphonates affected by this notice are only those approved to treat osteoporosis, among them Merck’s Fosamax, Warner Chilcott’s Actonel, GlaxoSmithKline’s Boniva and Novartis’ Reclast.
This notice does not affect bisphosphonate drugs that only are used to treat Paget’s disease or high blood calcium levels due to cancer, such as Warner Chilcott’s Didronel, Novartis’ Zometa, Sanofi-Aventis’ Skelid.
Sandra Kweder, deputy director of the office of new drugs in the FDA’s Center for Drug Evaluation and Research, said: “The FDA is continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment.
“In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”
Bisphosphonates inhibit the loss of bone mass in people with osteoporosis and have been shown to reduce the rate of osteoporotic fractures – fractures that can result in pain, hospitalisation, and surgery – in people with osteoporosis.
While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates.
Under the FDA’s changes companies will also be required to produce a Medication Guide for patients when they pick up their bisphosphonate prescription.
This will describe the symptoms of atypical femur fracture and recommend patients notify their healthcare professional if they develop symptoms.
The warning follows from the FDA’s Drug Safety Communication announced in March concerning the US regulator’s ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures.
The FDA has since reviewed all available data on bisphosphonate use, including data summarised in the American Society for Bone Mineral Research Task Force report.
The report recommended additional product labelling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures.
Ben Adams
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