RaplonŽ

[MSClarkEMS@aol.com]

Thought I would share this in case anyone missed it...

SafetyAlerts
March 30, 2001
RaplonŽ Voluntarily Withdrawn
West Orange, NJ (SafetyAlerts) - The injectable anesthesia drug RaplonŽ 
(rapacuronium bromide) is being voluntarily withdrawn from the market after 
its manufacturer received reports indicating that the drug may be associated 
with bronchospasm - a mild to severe inability to breathe normally that can 
lead to permanent injury or death. Five deaths, reported to the manufacturer, 
occurred during the administration of Raplon.

The drug's sponsor, Organon Inc., of West Orange, N.J., contacted FDA and 
sent a letter beginning March 27, 2001, to all anesthesiologists, hospital 
pharmacists, and other consignees of the drug, notifying them of the 
voluntary withdrawal of the drug and providing information on how to return 
unused inventory back to the company. RAPLON was administered in hospital and 
other surgical settings as a muscle relaxant for breathing tube placement and 
surgery. Other drugs on the market may be prescribed for the same purpose, 
and this withdrawal does not affect the overall availability of 
anesthesiology drugs.

FDA approved RAPLON for this indication in August 1999 after more than a year 
long review of Organon's new drug application. Although the drug's approved 
labeling did note the occurrence of bronchospasm in a small percentage of 
clinical trial patients receiving the drug, post-marketing reports indicate 
that the risk of injury from bronchospasm may be greater than was suggested 
in clinical trials.

More information is available in the company's market withdrawal letter.

http://www.safetyalerts.com/recall/f/01/raplon.htm

Fly Safe - Matt Clark, EMT-P

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