Anesthesia Drug Pulled From Market
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Health Headlines

Friday March 30 10:27 AM ET
Anesthesia Drug Pulled From Market

NEW YORK (Reuters Health) - An anesthesia drug is being voluntarily withdrawn from the market by the manufacturer after five deaths were reported in patients given the medication.

The drug, Raplon (rapacuronium bromide) is a muscle relaxant, given to patients by injection. The medication makes it easier for anesthesiologists to insert breathing tubes in patients' throats.

Reports have suggesting that the risk of injury from bronchospasm in patents receiving the drug may be greater than it seemed during clinical trials. Bronchospasm is a constriction of the bronchial tubes in the lungs, which causes difficulty breathing.

The manufacturer, Organon Inc., sent a letter earlier this week to anesthesiologists, hospital pharmacists and others who purchase and use the drug, informing them of the voluntary withdrawal.

According to the letter, the drug's labeling ``lists bronchospasm as an adverse event which occurred in 3.2% of patients in premarketing clinical trials.''

``We have now received reports of several serious adverse bronchospasm events, including a few unexplained fatalities,'' the letter continues. ``In each of these cases, the cause is unknown, as there were multiple drugs administered and other conditions present. From our surveillance of post-marketing spontaneous reporting, it appears that the incidence is within labeling. However, the severity of these events, up to and including mortality, that has been reported postmarketing, was not seen in clinical trials.''

Because the adverse event reporting is conducted through a voluntary system and comes from ``a population of unknown size,'' frequency of the events is difficult to pinpoint, the company noted.

Earlier Stories
Women Less Sensitive to Anesthesia: Study (March 23)