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Raplon® Lawsuit | Raplon Lawyer | Raplon FDA Recall | Raplon Side Effects

Manufacturer: Organon Uses: Used to complement general anesthesia in order to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgical procedures.

raplon Raplon is an anesthetic manufactured by Organon, Inc. and approved by the Food and Drug Administration in August of 1999. On March 30, 2001 Organon announced that it was withdrawing Raplon from the market after several reports of severe adverse reactions in patients taking Raplon. Such side effects include, but may not be limited to, bronchospasm and death. Organon informed doctors to remove all packages of Raplon from their shelves immediately.

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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, said John Jenkins, head of the FDA office that evaluated Raplon.

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.

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