FDA Panel Backs Pfizer Osteoporosis Drug for Spinal Fractures, Now Awaits Approval

September 10, 2008
by: Sylvia Marten

Fablyn, an osteoporosis drug for post-menopausal women made by Pfizer, has been backed by an FDA expert advisory panel. It must now go through a few more steps before being approved for nationwide use.

The FDA panel, by a 9-3 vote, voted that Fablyn helped decrease the risk of vertebral fractures due to osteoporosis in post-menopausal women when compared to a placebo. According to Dr. Sandra Carson, the chairwoman of the panel and Director of Reproductive Medicine at the Women and Infants Hospital of Rhode Island, "the panel felt, overall, women would benefit from having this drug available." The drug could prove to be an alternative therapy for women looking to avoid the hazards of other medications.

One of the issues still facing the drug is mortality rate. According to the Guardian, "Most panel members said they could not tell if a higher rate of deaths among Fablyn patients represented a true increase."

The FDA is now weighing the advice of the panel while it decides whether or not Fablyn is safe to be sold. A decision by the FDA is expected in October.

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