FDA Issues Warning About Canadian Drug Recall

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FDA Issues Warning About Canadian Drug Recall

 

http://www.consumeraffairs.com/news04/fda_canada_recall.html

 

The U.S. 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.

 

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. This product has been

available to the Canadian public with a prescription from physicians.

 

The FDA says 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.

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, the agency 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. 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 should 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 www.fda.gov/medwatch/report.htm, fax (800-332-0178) or 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.

 

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