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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

 
 

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