Organon withdraws muscle relaxant in USA on side-effect concerns

Akzo Nobel subsidiary Organon has decided to withdraw from the marketits non-depolarizing neuromuscular blocking agent, Raplon (rapacuronium bromide), after it was linked to five deaths and around 90 other cases of serious side effects, mainly severe bronchospasm. Raplon is given intravenously, along with general anesthetics, and is used to facilitate the insertion of breathing tubes and during surgery.

Media reports indicate that pediatric anesthesiologists have been exchanging warnings about Raplon via the Internet, while three articles and an editorial about the drug, describing cases in which children nearly died while it was being administered, are scheduled to be published in May in the Journal of Anesthesiology. Although reports of side effects have been received by the US Food and Drug Administration, the agency noted that it had not asked Organon to withdraw the drug, and applauded the company for its swift action.

Bronchospasm was a recognized side effect of Raplon on approval, with mild cases occurring in around 3% of patients in clinical trials, as well as with other drugs in the same class. Indeed, severe bronchospasm has rarely been encountered with any muscle relaxant drug, and this may have had a bearing on the swiftness of Organon's decision to withdraw Raplon from sale.