Anesthesia Drug Withdrawn from Market

The U.S. Food and Drug Administration (FDA) has announced that an anesthesia drug, rapacuronium bromide (Raplon), has been voluntarily withdrawn from the market by the manufacturer, following reports that five patients had experienced severe bronchospasm and died while receiving the drug. Two of the patients who died were children.

The injectable drug was administered in hospital and other surgical settings as a muscle relaxant for breathing tube placement and surgery. There have been a number of other reports of severe broncospasm in patients administered the drug, mainly in children. Although the drug's approved labeling did note the occurrence of bronchospasm in a small percentage of clinical trial patients receiving the drug, these postmarketing reports indicate that the risk of injury from bronchospasm may be greater than was suggested in clinical trials.

Three articles about the drug are to be published in the Journal of Anesthesiology in May. The manufacturer of the drug is Organon, Inc. (West Orange, NJ, USA). Healthcare providers with questions about the product can contact the U.S. Food and Drug Administration (FDA) at www.fda.gov/medwatch.




Related Links:
FDA
Organon