March 7, 2008WASHINGTON (AP) -- Federal health regulators said Friday a Schering-Plough Corp. drug appears effective at helping patients recover from anesthesia, though some safety questions remain.
A Food and Drug Administration panel of experts will meet next Tuesday to review Schering's Bridion, an injectable drug designed to reverse the effects of anesthesia in patients after surgery.
An analysis of the drug was posted to the FDA Web site Friday, along with questions the agency will ask the panel. The agency is not required to follow the recommendation of its panel, though it usually does.
Similar drugs are on the market, but Schering said Bridion is unique because it reverses the effects of mild and serious anesthesia.
FDA reviewers said Bridion appears safe in healthy adults, but that additional studies may be needed to answer questions about allergic reactions and the drug's effects on children's' teeth.
The agency said it is concerned about reports of some adults having hypersensitivity reactions while taking the drug. Schering is studying the reactions, and FDA said the results "could have a significant effect on the overall finding of safety" for the drug.
FDA also said Schering has not addressed Bridion's effects on teeth in young children. Studies of the drug in young rats showed it interfered with growth of tooth enamel.
Studies of the drug in human adults also showed minor changes in bone strength, though they were not considered significant.
Only one study of Bridion in children has been completed, the FDA said.
The agency will ask its advisers Tuesday whether the company should be required to conduct additional studies in children.
Shares of Schering Plough Corp. fell 38 cents, or 1.9 percent, Friday to $19.65 in midday trading.
Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
