WASHINGTON, DC (December, 14, 2004) –The Food and Drug Administration (FDA) is advising consumers about a Canadian recall of Carbolith (Lithium Carbonate) 150 mg capsules distributed in Canada by Valeant Canada Ltd.
Although Carbolith is not an FDA-approved product, the agency is investigating several Internet websites that are advertising Carbolith for sale to consumers in the United States.
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.
As a precaution, Health Canada recently advised individuals taking Carbolith 150 mg capsules to continue taking their medication and to consult their health care professional as soon as possible.
The product has been available to the Canadian public with a prescription from physicians. U.S. consumers who have purchased this drug through the Internet and taken it for the treatment of manic-depressive illness “could experience adverse events associated with lowered blood lithium levels,” according to the FDA.
The agency said the “adverse 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, the FDA said.
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, the agency warned.
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.
Because lithium carbonate requires careful, closely monitored dosing and periodic blood tests to measure the level of the drug in the blood, U.S. consumers who have taken Carbolith 150 mg capsules are advised by the FDA to continue to take the product and consult their health care provider as soon as possible so that an alternative medication can be prescribed.
The FDA urged consumers and health care professionals to report adverse reactions associated with Carbolith 150 mg capsules to FDA’s MedWatch program online at www.fda.gov/medwatch/report.htm, by fax (800-332-0178) or by phone (800-332-1088) and to Health Canada by toll-free telephone at (866) 234-2345 or by toll-free fax at (866) 678-6789.