New Thalomid Label Warns of Seizure Risk
NEW YORK (Reuters Health) Sept 11 - Ongoing evaluation of Celgene Corp.'s Thalomid (thalidomide) under the US Food and Drug Administration's STEPS program has yielded changes to the drug's label, most notably the warning that Thalomid may induce seizures.
The System for Thalidomide Education and Prescribing Safety (STEPS) is designed for the safe and effective dispensing of thalidomide. It aims to prevent the birth defects caused several decades ago when thalidomide was prescribed to pregnant women as a remedy for morning sickness.
Operated by Celgene, the FDA, other government agencies and advocacy groups, STEPS has been in place since Thalomid was first approved in the US in 1998 for a leprosy treatment indication. The drug is also now used experimentally to treat some patients with advanced cancer.
In addition to demanding patient and physician compliance, the STEPS program constantly monitors Thalomid for safety, FDA spokesperson Laura Bradbard told Reuters Health on Monday. As part of that effort, any adverse reactions to the drug must be reported to the FDA and acted on by the agency.
Following recent reports of seizures, including grand mal seizures, in patients taking the drug, the FDA has added labeling text that advises close monitoring of Thalomid patients with a history of seizures or with other risk factors for their development.
However, the subsection notes that most Thalomid patients who suffered seizures "had disorders that may have predisposed them to seizure activity, and it is not currently known whether thalidomide has any epileptogenic influence." The new warning does not advocate that physicians refrain from prescribing the drug to such patients.
Reuters Health News for the Professional
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