Company warns of side effects with zonisamide. (Pediatric Patients).
The Food and Drug Administration in March 2000 approved zonisamide, marketed as Zonegran by Elan Pharmaceuticals, as adjunctive therapy in people aged 16 years and older with partial seizures. The drug has been marketed in Japan for more than 10 years, where most of the 40 pediatric cases of zonisamide-related hyperthermia and oligohidrosis were reported.
Many of the cases were reported after exposure to high temperatures; some people developed heat stroke and were hospitalized. No fatalities were reported, however. "Patients, especially pediatric patients, treated with Zonegran should be monitored closely for evidence of decreased sweating and increased body temperature, especially in warm or hot weather," Elan Pharmaceuticals said in a letter issued to health care professionals this summer.
The company has added a warning in boldface type to the drug's label. The warning advises caution when zonisamide is used with other drugs that predispose patients to heat-related disorders, such as carbonic anhydrase inhibitors and drugs that have anticholinergic activity.
As of Dec. 31, 2001, 40 cases of oligohidrosis (decreased sweating) and an elevation in body temperature had been reported among individuals using zonisamide.
For more information, contact Elan at 888-638-7605.
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|Title Annotation:||Elan Pharmaceuticals|
|Publication:||Clinical Psychiatry News|
|Article Type:||Brief Article|
|Date:||Sep 1, 2002|
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