March 27, 2001 - U.S. Say Organon Pulling Anesthesic From Market

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Raplon, cleared for sale in the United States in August 1999 by the Food and Drug Administration, is going to be withdrawn from the market by its manufacturer Organon, after it was reported that five patients died while being given the drug and that it may be linked with breathing trouble that can lead to permanent injury.

Hospitals and other surgical facilities use Raplon as a muscle relaxator.

However, even before FDA approved the drug it had some knowledge that some patients had an adverse reaction to the anesthetic. The reaction, known as bronchospasm, causes an inability to breath normally and could be mild or severe.

But the numbers seen after the drug became widely available "indicate that the risk of injury .... may be greater than was suggested," commented John Jenkins, an FDA official.

According to Jenkins, all drugs similar to Raplon have been linked with the same problem, "but this drug (Raplon) seems to be causing more severe bronchospasm."

The FDA is not, however, going to withdraw or review the safety of other neuromuscular blocking drugs similar to Raplon, known as neuromuscular blocking agents, concluded Jenkins.

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