http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v17n3_e.html#1 Home > Drugs & Health Products > MedEffect > Canadian Adverse Reaction Newsletter (CARN) Contact MHPD-DPSC This document is also available in PDF format [carn-bcei_v17n3_e.pdf] Pages: 4, Size: 571 K, Date: 2007-07-03 Canadian Adverse Reaction Newsletter Volume 17 . Issue 3 . July 2007 Health Products and Food Branch Marketed Health Products Directorate In this Issue: Benadryl Total: medication incident and stroke Rosiglitazone and parotid gland enlargement: update Adverse reaction reporting: education modules Case presentation: Norethindrone and decreased breast milk production Summary of advisories Scope This quarterly publication alerts health professionals to potential signals detected through the review of case reports submitted to Health Canada. It is a useful mechanism to disseminate information on suspected adverse reactions to health products occurring in humans before comprehensive risk-benefit evaluations and regulatory decisions are undertaken. The continuous evaluation of health product safety profiles depends on the quality of your reports. Reporting Adverse Reactions Contact Health Canada or a Regional AR Monitoring Office free of charge Phone: 866-234-2345 Fax: 866-678-6789 Click here for the Adverse Reaction Reporting Form Caveat: Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown. Benadryl Total: medication incident and stroke In October 2006, Health Canada received a report of a suspected adverse reaction involving a medication incident related to product labelling and packaging. A 64-year-old woman consulted her family physician after experiencing an allergic reaction. She was given epinephrine (0.3mg subcutaneously) and was advised to take Benadryl (diphenhydramine) 3 times daily for 3 days. Inadvertently, the patient bought Benadryl Total (diphenhydramine, pseudoephedrine and acetaminophen). She was unaware that this product contained pseudoephedrine and acetaminophen. After the second day of use, the patient experienced a stroke that affected her vision and speech. No other risk factors for stroke were reported other than age and use of pseudoephedrine. Health products with sound-alike names and look-alike packaging and labelling can cause confusion for both consumers and health professionals and contribute to inappropriate product selection (Fig.1). Such errors may result in serious patient harm.1,2 Health professionals are reminded that product line extensions can sometimes lead to confusion for their patients in choosing the intended product. Patients are encouraged to always read the product's label carefully and to consult their pharmacist whenever they select self-care products. Michel Trottier, BScPhm, RPEBC, RPh, Health Canada ----------------------- To change your mail settings or leave the C-PALSY list, go here: http://listserv.icors.org/SCRIPTS/WA-ICORS.EXE?SUBED1=c-palsy