FDA warns of recall of unapproved Canadian drug sold to Americans over the Internet

Wednesday, December 8th 2004, 11:05 am

By: News On 6

WASHINGTON (AP) _ The Food and Drug Administration issued a warning Wednesday regarding the use of Carbolith capsules, a treatment for manic-depressive illness that is distributed by a Canadian company.

The drug is not approved by the FDA, but Americans could purchase it on the Internet.

Valeant Canada Limited issued a recall of Carbolith 150mg capsules because the company said the product may not deliver adequate amounts of the drug to ensure effective treatment, the warning said.

The FDA said that it is investigating Internet web sites that advertise Carbolith for sale to U.S. customers, because the drug is not approved by the FDA.

Consumers should consult with a health care professional as soon as possible, and should not discontinue use until they do so. The use of this drug should be closely monitored and switching drugs could lead to toxic effects, the FDA said in the warning.

Lesser effects include tremors of the hands, drowsiness, blurred vision, ringing in the ears and more severe reactions could include seizures, coma and death.