Raplon

Pharmaceutical maker Organon Inc. is withdrawing its anesthetic Raplon from the market after reports that five patients died while being given the drug, U.S. officials said on Thursday.

Organon, a unit of Akzo Nobel NV, notified regulators that it was voluntarily pulling Raplon after reports showed it may be linked with breathing trouble that can lead to permanent injury or death, the Food and Drug Administration (FDA) said.

About 90 cases of that problem were reported, said John Jenkins, head of the FDA office that evaluated Raplon. Jenkins said he did not know how many patients had been given Raplon, and officials at Organon were not immediately available for comment.

The FDA cleared Raplon for sale in the United States in August 1999. Critics have charged the agency with approving drugs too quickly and later having them come off the market for safety reasons. The Raplon review took more than a year, the FDA said.

Raplon was given by injection in hospitals or other surgical facilities. It was used as a muscle relaxant for when doctors placed breathing tubes or for surgery.

Officials knew before they approved Raplon that some patients had an adverse reaction known as bronchospasm, an inability to breath normally that can be mild to severe, Jenkins said.

In clinical trials before its approval, 3.2 percent of patients given Raplon had bronchospasm, compared with 2.1 percent for a comparison drug. That was "not enough to be worrisome," Jenkins said.

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

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

The breathing difficulties were noted in Raplon's prescribing information, he added.

The problem occurred "very rapidly" after the drug was injected, Jenkins said. Patients who received Raplon during previous procedures without serious trouble "probably don't need to worry" about having a complication now, he said.

The FDA is not reviewing the safety of any drugs similar to Raplon, known as neuromuscular blocking agents, Jenkins said.

Organon, based in West Orange, N.J., is sending letters to anesthesiologists, pharmacists and others to notify them it is withdrawing the drug, the FDA said.

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