Pfizer's Fablyn gets nod from FDA panel

14 September 2008

Global drug giant Pfizer has received a positive recommendation for its controversial drug Fablyn (lasofoxifene tartrate) from a US Food and Drug Administration panel.

The panel voted nine to three that the benefits of Fablyn in the treatment of post-menopausal women with osteoporosis outweigh the drug's risks. Known side effects include blood clots and vaginal bleeding.

Fablyn has also been linked to an increase in mortality during recent trials, but Pfizer maintain the deaths were non-significant and the FDA panelists said they did not have enough information to identify any cause for the increased occurence.

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