Schering Anesthesia Data Raise Concerns-US FDA Rep
Tue Mar 11, 2008 3:04pm EDT
SILVER SPRING, Md. (Reuters) - Recently submitted data on allergic reactions related to a Schering-Plow Corp (SGP.N: Quote, Profile, Research) drug aimed at reversing the effects of anesthesia raise concerns, a U.S. regulator said on Tuesday.
A Food and Drug Administration advisory panel is weighing the risks and benefits of the drug Bridion, known generically as sugammadex. The panel will vote later today on whether to recommend approval.
Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology drugs, said data received in the last two weeks by the FDA "raise concerns" about the drug's safety.
The agency had been waiting for a safety update.
A Schering-Plow official told the panel that only one patient suffered from so-called hypersensitivity -- an allergic reaction marked at times by rash, flushing and heart disturbances. That case was mild and resolved itself, said Patrick Boen, a senior medical director at Schering-Plough's anesthesia unit.
FDA staff cited eight cases of hypersensitivity, though an agency reviewer noted that only three cases may be related to the drug itself based on the timing of the reaction.
The "safety review is ongoing," and issues to be resolved include the hypersensitivity reactions and abnormal electrical activity in the heartbeat, FDA staff said in review documents.
None of the hypersensitivity reactions rose to the level of "serious," but the link between the drug and heart-related side effects cannot be ruled out, the FDA said.
The drug Bridion aims to reverse the muscular blocking effects of certain muscle relaxants and help patients recover more quickly from anesthesia after medical procedures.
The FDA typically takes the advice of its advisory panels.
Schering-Plow shares rose 1 cent to $19.66 in late morning trade on the New York Stock Exchange.
(Reporting by Kim Dixon, editing by Gerald E. McCormick and Derek Caney)
Got my guns, you have yours?
