Page 4: Health Product InfoWatch - January 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.
The risk of colitis and gastrointestinal perforation has been added to the Warnings and Precautions and Adverse Reactions sections of the Canadian product monograph for Mekinist (trametinib).
Key messages for healthcare professionals:Footnote 1
- Colitis and gastrointestinal perforation, including fatal outcome, have been reported in patients taking Mekinist.
- Mekinist monotherapy or in combination with dabrafenib should be used with caution in patients with risk factors for gastrointestinal perforation, including a history of diverticulitis, metastases to the gastrointestinal tract and concomitant use of medications with a recognized risk of gastrointestinal perforation.
- Patients should be advised to seek immediate medical care if they develop symptoms of colitis and gastrointestinal perforation.
Additional information concerning the risk of respiratory depression has been added to the Warnings and Precautions section of the Canadian product monograph (CPM) for Neurontin (gabapentin). The CPM already included information on the risk of respiratory depression when used concomitantly with opioids.
Key messages for healthcare professionals:Footnote 2
- Gabapentin has been associated with central nervous system (CNS) depression including sedation, somnolence, loss of consciousness as well as serious cases of respiratory depression.
- Patients with compromised respiratory function, respiratory or neurological disease, renal impairment and the elderly are at higher risk of experiencing these severe adverse effects.
- Concomitant use of CNS depressants with gabapentin is also a contributing factor.
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