TAP ordered to cease distribution of Uprima press release
The US Food and Drug Administration has ordered TAPPharmaceuticals to stop distributing an April 10 press release concerning the approval recommendation from an FDA advisory committee for its impotence drug Uprima (apomorphine sublingual; Marketletter April 17). The release fails to say that side effects could include low blood pressure and fainting, and does not mention that the panel recommended the drug carry a warning of interactions with nitrates and alcohol. The omissions violate rules on drug promotion by not presenting a balanced risk:benefit profile, the FDA said in its letter to TAP.
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