Rapacuronium Withdrawn from Market
Organon Inc. has withdrawn rapacuronium bromide from the U.S. market because the neuromuscular blocking agent has been linked to several cases of bronchospasm, including a few deaths.
The company, in a notice (PDF) dated March 27, requested the immediate return of all Raplon vials to the firm's West Orange, N.J., facility.
During the clinical studies conducted before the Food and Drug Administration approved the drug for marketing in August 1999, bronchospasm occurred in 3.2 percent of the patients who received rapacuronium bromide, compared with 2.1 percent of those who received succinylcholine chloride. None of the patients died. Less than 1 percent of patients who received rocuronium bromide, vecuronium bromide, or mivacurium chloride, or another neuromuscular blocking agent during the studies had an episode of bronchospasm.
Because the recent reports of bronchospasm were submitted voluntarily after the drug became widely available, the company could not calculate the exact frequency of the adverse event. In the March 27 notice, the firm estimated the postmarketing occurrence of the adverse event at about the same rate as stated in the product labeling, 3.2 percent.
Rapacuronium bromide was indicated for use in conjunction with general anesthesia to facilitate intubation or relax skeletal muscles during surgical procedures. Supplies of Raplon had recently been hard to obtain, according to the drug shortage bulletin prepared by the University of Utah Drug Information Service and posted elsewhere at the ASHP Web site.