Page 2: Health Product InfoWatch - November 2017

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.

Clobex shampoo (clobetasol propionate solution 0.05% w/w)

Clobex shampoo is now contraindicated in children under 2 years of age. This information has been included in the Indications and Clinical Use, Contraindications and Warnings and Precautions sections of the Canadian product monograph for Clobex shampoo.

Key messages for healthcare professionals:Footnote 1

  • Clobex shampoo must not be used in children under 2 years of age.
  • Use in patients between 2 and 18 years of age is not recommended.
  • Hypothalamic pituitary adrenal axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Reference
Footnote 1

Clobex shampoo (clobetasol propionate solution 0.05% w/w) [product monograph]. Thornhill (ON): Galderma Canada Inc.; 2017.

Return to footnote 1 referrer

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