Advisory

October 2004

Health Canada advises consumers to consult with their physicians on the use of Carbolith 150 milligram products

2004-10-29 - Health Canada is advising consumers of a recall of Carbolith 150 milligram (mg) capsules distributed in Canada by Valeant Canada Limited (formerly ICN). Carbolith 150 mg capsules are used in the treatment of manic-depressive illness. The company's recent testing has led to the conclusion that the product may not deliver adequate amounts of the drug to ensure effective treatment.

As a precaution, Health Canada advises individuals taking Carbolith 150 mg capsules to continue to take their medication and to consult their health professional as soon as possible. Further instruction about suitable replacements often requires the performance of blood tests to measure the level of the drug in the blood in order to prescribe alternative medication. Your physician is best placed to advise you of a suitable alternative.

Potential adverse reactions to these products could include a worsening of manic-depressive illness, a serious psychiatric condition. A worsening of this condition could cause symptoms associated with mania, which may include motor hyperactivity, delusions of grandeur, poor judgement and aggressiveness. A severe bout of depression or mania, during which an individual could become a danger to himself/herself or others, can often require inpatient hospitalization.

Additionally, there is a potential risk that a toxic effect might occur in patients who are used to the lower than expected release of drug when exposed to the full drug dosage. Mild toxicity could result in tremours 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.

The Carbolith 150 mg product comes in capsule form. This product has been available to the public, with a prescription from physicians. The name of the product is written on the label of the container.

Health Canada became aware of the situation associated with Carbolith via a letter the company sent to the Health Products and Food Branch Inspectorate on October 28, 2004. Consumers and health care professionals are urged to report adverse reactions to Health Canada by toll-free telephone at (866) 234-2345 or by toll-free fax at (866) 678-6789. For further information, please contact the nearest Health Canada Regional Operational Centre.

Regional Operational Centres:

British Columbia, Alberta, Northwest Territories, Yukon
Operational Manager
3155 Willingdon Green
Burnaby, British Columbia V5G 4P2
Phone (604) 666-3350 or Fax (604) 666-3149

Manitoba, Saskatchewan
Operational Manager
510 Lagimodiere Blvd
Winnipeg, Manitoba R2J 3Y1
Phone (204) 983-5490 or Fax (204) 984-2155

Ontario, Nunavut
Operational Manager
2301 Midland Ave.
Toronto, Ontario M1P 4R7
Phone (416) 973-1600 or Fax (416) 954-4583

Quebec
Operational Manager
1001 Rue St-Laurent Ouest
Longueuil, Quebec J4K 1C7
Phone (450) 646-1353 or Fax (450) 928-4455

Atlantic
Operational Manager
Suite 1625, 16th Floor
1505 Barrington Street
Halifax, Nova Scotia B3J 3Y6
Phone (902) 426-2160 or Fax (902) 426-6676

Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988

Public Inquiries:
(613) 957-2991