As unexpected decisions from the FDA go, the refusal to grant approval for Schering-Plough’s sugammadex, which reverses the paralysing effects of anaesthetics, must rank as one of the most surprising.
Safety was the reason given for knocking back the drug, which was unanimously backed by an FDA advisory committee and given a green light in Europe this week, specifically concerns related to hypersensitivity and allergic reactions. Considering the drug is viewed as safer than drugs currently used in the setting, the decision has been put down to the FDA taking an ultra cautious approach at a time when it is under huge pressure from Congress as a result of previous high profile safety scares.
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