Even though it is already marketed as a gel and a cream, an oral form ofAllergan's tazarotene failed to pass muster with a joint panel of two US Food and Drug Administration advisory committees on July 12. The panel voted nine-three, with four abstentions, that the benefits did not outweigh the risks of the drug for treating moderate-to-very-severe psoriasis.
"It works great for some people," said panelist Eric Holmboe of Yale University School of Medicine. But, he added: "it's not very efficient." Dr Holmboe voted against approval.
The panel - a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee - also felt that Allergan had not crafted a detailed risk management plan to minimize pregnancies in those taking the drug. Tazarotene, a retinoid, is known to cause birth defects. There was some indication also that it might accumulate in semen, though the panel said more study was needed to say whether a male patient could pass on the teratogenicity.
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