Health Canada recalls drug to control metal toxicity in dialysis patients

Health Canada recalls drug to control metal toxicity in dialysis patients

Mon Feb 23, 4:33 PM

By The Canadian Press

TORONTO - Health Canada is recalling some lots of a medication used to treat iron and aluminum toxicity in kidney dialysis patients because of the potential for tiny particles to form after the drug is prepared for intravenous administration.

The federal agency is working with manufacturer Hospira Healthcare Corp. to recall certain lots of Desferrioxamine Mesilate for Injection.

The following are being recalled: Lot U072231AA in a 500-milligram format and Lot U102237AA in a two-gram format. The lot number is found on the label of the carton and on the vial.

Hospira Healthcare acquired the product from another company, so the medication will bear the name Mayne Pharma Canada Inc. on the label and carton.

Health Canada said the lots may produce some cloudiness after preparation, the result of small particles that form. These particles may block small blood vessels after injection, so the drug solution should not be used if it becomes cloudy.

Desferrioxamine Mesilate is prescribed for the treatment of acute or chronic iron toxicity and chronic aluminum overload in dialysis patients with end-stage kidney failure.

Patients should not stop using the drug without consulting their health-care practitioner, Health Canada said.

Any affected lot should be returned to the pharmacy for replacement. Patients should check for the DIN and lot number on the product packaging or consult with their pharmacist to determine whether they have product from the affected lots.

Patients should report any adverse reactions to their health-care provider or pharmacist. No adverse reactions have been reported to Health Canada.

For more information, contact Health Canada's public inquiries line at 613-957-2991 or toll-free at 1-866-225-0709.

http://ca.news.yahoo.com/s/capress/090223/health/health_drug_recall_1