Drug & Patient Safety News |
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Two short safety news reports are included here for your information.
● The Problematic “Walnut” That Singapore Has Been Trying to Crack….
In Issue 32 of our eBulletin, we reported US FDA’s caution about the safety concerns of the drug. Now, Health Canada also reported that in the first eight months after Pfizer began marketing its smoking cessation drug, they received 107 reports of adverse drug reactions suspected of being associated with varenicline. Of these, 46 involved psychiatric reactions including aggression, depression and suicidal ideation. Others involved amnesia, abnormal dreams, anxiety, insomnia, and abnormal thinking. The drug's prescribing information was recently updated to reflect post-market reports of mood and behaviour changes, including suicide. Health Canada would review the drug’s safety profile and take appropriate action if necessary. Unlike the US FDA, a public advisory has not been issued to Canadian public yet as the reports were not strong enough as scientific evidence to implicate a causal relationship between the drug to the psychiatric responses. Adapted from: http://www.canada.com/ottawacitizen/news/story.html?id=bd881df2-60c1-4ace-a2fb-0aeedfe55916
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