Health Canada is advising of a potential risk related to Pre-Pen, a penicillin allergy test

Jun 20 2004

Health Canada is advising health professionals and consumers of a potential risk related to Pre-Pen, a product used to test an individual's allergy to penicillin. Pre-Pen is distributed in Canada by Omega Laboratories Ltd.

Recent information provided to Health Canada shows that lot number 91121 of this product, which has been available since November 2003, is subpotent. This means that test results may be inaccurate and that some people might be falsely diagnosed as not having a penicillin allergy.

As a precaution, Health Canada is advising patients tested for penicillin allergy since November 2003 to avoid the use of penicillin products and consult their physician for further advice on testing for allergies.

Health Canada is working with the distributor to inform physicians, hospital administrators and pharmacists of this potential risk and to recall the product.

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of serious and/or unexpected adverse reactions in patients using Omega Laboratories' Pre-Pen should be reported to Health Canada.