The United States Food and Drug Administration is advising consumers about a Canadian recall of Carbolith (Lithium Carbonate) 150 mg capsules distributed in Canada by Valeant Canada Limited. Although Carbolith is not an FDA-approved product, FDA is investigating several Internet websites advertising Carbolith for sale to U.S. consumers. Carbolith 150 mg capsules are used in the treatment of manic-depressive illness. The company's recent testing led to the conclusion that the product may not deliver adequate amounts of the drug to ensure effective treatment.

The FDA advises that consumers who have purchased this drug through the Internet and taken it for the treatment of bi-polar disease (manic-depressive illness) could experience adverse events associated with lowered blood lithium levels. These events could include a worsening of manic-depressive illness, a serious psychiatric condition. A worsening of this condition could result in symptoms associated with mania (such as motor hyperactivity, delusions of grandeur, poor judgment and aggressiveness) and depression or suicidal thoughts which may require hospitalization.

Additionally, consumers who may have taken the Carbolith product for several weeks or more may experience toxic effects when they switch to a lithium carbonate product that delivers adequate amounts of the drug. Mild toxicity could result in tremors of the hands, thirst and more frequent urination, drowsiness, ringing in the ears and blurred vision. More severe toxicity could result in confusion, muscle twitching, vomiting, diarrhea, seizures, coma and death.

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