Page 2: Health Product InfoWatch – January 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.
Additional information concerning the risk of gastrointestinal perforation has been added to the Warnings and Precautions section of the Canadian product monograph for Ofev (nintedanib).
Key messages for healthcare professionals:Footnote 1
- Cases of gastrointestinal perforations have been reported during the post-marketing period. Many of them were serious and some have resulted in fatal outcomes, although a definitive causal relationship to Ofev has not been established.
- Particular caution should be exercised when treating patients with previous abdominal surgery, a recent history of hollow organ perforation, previous history of peptic ulceration, diverticular disease, or receiving concomitant corticosteroids or non-steroidal anti-inflammatory drugs. Ofev should only be initiated at least 4 weeks after abdominal surgery.
- Only use Ofev in patients with a known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk. Therapy with Ofev should be permanently discontinued in patients who develop gastrointestinal perforation.
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