FDA panel votes in favor of Pfizer’s Fablyn

NEW YORK The benefits of Pfizer’s osteoporosis drug Fablyn outweigh its risks, a Food and Drug Administration panel said, recommending the drug for postmenopausal women in a 9-3 vote Monday.

The advisers on the panel said they could not determine whether deaths among patients using the drug were a statistically significant increase over deaths among those receiving a placebo.

But, they said, the decision was neither a clear rejection of the drug nor a clear endorsement.

Pfizer had maintained that numbers showing an increase in deaths among patients using the drug, known generically as lasofoxifene tartrate, were not statistically significant.