Page 4: Health Product InfoWatch - February 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.

Tramadol-containing products (Durela, Ralivia, Tramacet, Tridural, Ultram, and Zytram XL)

Additional information concerning the risk of respiratory depression in CYP2D6 ultra-rapid metabolizers has been added to the Warnings and Precautions and Action and Clinical Pharmacology sections of the Canadian product monographs for tramadol-containing products: Durela, Ralivia, Tramacet, Tridural, Ultram, and Zytram XL.

Key messages for healthcare professionals:Footnote 1,Footnote 2,Footnote 3,Footnote 4,Footnote 5,Footnote 6

  • Some individuals may be CYP2D6 ultra-rapid metabolizers. These individuals convert tramadol more rapidly than other people into its more potent opioid metabolite O-desmethyltramadol (M1). This rapid conversion could result in higher than expected opioid-like side effects including life-threatening respiratory depression.
  • The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese, Japanese and Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups.

Votrient (pazopanib)

The risk of male-mediated teratogenesis has been included in the Warnings and Precautions section of the Canadian product monograph for Votrient (pazopanib).

Key messages for healthcare professionals:Footnote 7

  • Male patients (including those who have had vasectomies) with sexual partners who are pregnant, possibly pregnant, or who could become pregnant should use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose of drug.

Zyprexa (olanzapine)

The risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been included in the Warnings and Precautions and Adverse Reactions sections of the Canadian product monograph for Zyprexa (olanzapine).

Key messages for healthcare professionals:Footnote 8

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure.
  • DRESS consists of a combination of 3 or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis.
  • Zyprexa should be discontinued if DRESS is suspected.
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