Page 2: Health Product InfoWatch – February 2018

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Product Monograph Updates

The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected for your awareness. A complete list of safety labelling updates for brand name pharmaceutical drugs is available on Health Canada's Web site.

Alcaine (proparacaine hydrochloride)

The risk of abuse or misuse has been included in the Warnings, Adverse Reactions, and Consumer Information sections of the Canadian prescribing information for Alcaine.

Key messages for healthcare professionals:Reference 1

  • Repeated use or abuse of this product may lead to corneal epithelial toxicity and defects, which may progress to permanent corneal damage, such as corneal opacification with accompanying loss of vision.
  • Alcaine should only be put into patients' eyes by a healthcare professional and should not be dispensed for patients' own use.
Reference 1

Alcaine (proparacaine hydrochloride) [prescribing information]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2018.

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Concerta (methylphenidate hydrochloride)

The risk of cerebrovascular disorders has been included in the Warnings and Precautions, Adverse Reactions (Post-Market Adverse Drug Reactions) and Consumer Information sections of the Canadian product monograph for Concerta.

Key messages for healthcare professionals:Reference 2

  • Cerebrovascular disorders (including cerebral vasculitis and cerebral hemorrhage) have been reported with the use of Concerta.
  • Consider cerebrovascular disorders as a possible diagnosis in any patient who develops new neurological symptoms that are consistent with cerebral ischemia during Concerta therapy. These symptoms could include severe headache, unilateral weakness or paralysis, and impairment of coordination, vision, speech, language, or memory.
  • If a cerebrovascular disorder is suspected during treatment, discontinue Concerta immediately.
  • In patients with pre-existing cerebrovascular disorders (e.g., aneurysm, vascular malformations/anomalies), treatment with Concerta is not recommended.
Reference 2

Concerta (methylphenidate hydrochloride) [product monograph]. Toronto (ON): Janssen Inc.; 2017.

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Zoloft (sertraline hydrochloride)

New information regarding the risk of prolongation of the QTc interval has been added to the Precautions and Adverse Reactions sections of the Canadian product monograph for Zoloft (sertraline hydrochloride).

Key messages for healthcare professionals:Reference 3

  • Sertraline has been demonstrated to cause a concentration-dependent prolongation of the QTc interval.
  • Caution should be exercised when sertraline is prescribed in patients with an increased risk of QT prolongation including but not limited to those who are suspected to be at an increased risk of experiencing torsade de pointes during treatment with a QTc-prolonging drug.
Reference 3

Zoloft (sertraline hydrochloride) [product monograph]. Kirkland (QC): Pfizer Canada Inc.; 2018.

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