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