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Catalogue Entry: Summary Safety Review - ABILIFY and ABILIFY MAINTENA (aripiprazole) -...
A safety review was conducted to evaluate the potential link between Abilify and Abilify Maintena (aripiprazole) and certain behaviours where individuals cannot control their...-
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Catalogue Entry: Summary Safety Review - EYLEA (aflibercept) - Assessing the Risk of Side...
A safety review was carried out by Health Canada to evaluate the risk of harmful side effects in areas of the body other than the eye (systemic toxicity) associated with Eylea....-
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Catalogue Entry: Summary Safety Review - Finasteride - Assessing the Potential Risk of...
Health Canada reviewed the risk of potential serious muscle-related side effects with finasteride use because of reports in which these events were seen in patients treated with...-
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Catalogue Entry: Summary Safety Review - Finasteride - Assessing the Potential Risk of...
This safety review was carried out as a follow-up assessment on the potential risk of suicidality with the use of finasteride. The issue was first identified through Health...-
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Catalogue Entry: Summary Safety Review - Fluoroquinolones - Assessing the potential risk of...
Health Canada started a safety review following a review done by the FDA on systemic (taken by mouth or by injection) fluoroquinolone drugs. The FDA review showed that there...-
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Catalogue Entry: Summary Safety Review - Gabapentin - Assessing the Potential Risk of Serious...
In 2014, the product information for gabapentin products was updated to warn about the risk of serious breathing problems (respiratory depression) when it is used with an...-
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Catalogue Entry: Summary Safety Review - Gadolinium based contrast agents - Assessing the...
In 2016, Health Canada reviewed the risk of gadolinium build-up in the brain and potential neurological side effects in light of published studies showing that gadolinium may...-
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Catalogue Entry: Summary Safety Review - GARDASIL (Quadrivalent Human Papillomavirus [Types...
The safety of all vaccines, including Gardasil, is under continuous monitoring by Health Canada and the Public Health Agency of Canada. The safety of Gardasil was reassessed as...-
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Catalogue Entry: Summary Safety Review - Green tea extract-containing natural health products...
Health Canada reviewed the potential risk of liver injury with green tea extract-containing natural health products because of ongoing reports of serious liver injury worldwide,...-
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Catalogue Entry: Summary Safety Review - Hydrocodone-containing products - Assessing the Risk...
It is known that hydrocodone can slow breathing when too much is taken. The labelling for these drugs already warns of this risk and it applies to all ages, including children....-
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Catalogue Entry: Summary Safety Review - Hydroxyzine (ATARAX and generics) - Assessing the...
A safety review was undertaken soon after the European Medicines Agency notified Health Canada of the possibility that the use of hydroxyzine products could be associated with...-
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Catalogue Entry: Summary Safety Review - Intraocular lenses - Assessing the potential risk of...
As part of Health Canada's ongoing monitoring of glistening development in IOLs, Health Canada reviewed the available safety information related to this issue. Health Canada has...-
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Catalogue Entry: Summary Safety Review - INTUNIV XR (guanfacine hydrochloride) - Assessing...
A safety review was carried out to evaluate the potential risk of Raynaud's phenomenon in patients taking Intuniv XR. Raynaud's phenomenon is a disorder of the blood vessels,...-
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Catalogue Entry: Summary Safety Review - KEPPRA (levetiracetam) - Assessing the Potential...
Health Canada reviewed the potential risk of acute kidney injury with the use of levetiracetam, because of an article that was published by the WHO suggesting this risk. Health...-
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Catalogue Entry: Summary Safety Review - Lanoxin, Toloxin, Apo-digoxin, PMS-digoxin,...
Health Canada completed a safety review to evaluate if using digoxin was linked to a higher risk of death compared to patients not using digoxin. Results of the studies...-
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Catalogue Entry: Summary Safety Review - Levetiracetam and Methotrexate - Assessing the...
Health Canada carried out a safety review after learning that the European Medicines Agency was looking into a potential interaction between levetiracetam and methotrexate. The...-
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Catalogue Entry: Summary Safety Review - Loratadine - Abnormal heart rhythm (QT interval prolongation)
Health Canada carried out a safety review to investigate the potential risk of developing an abnormal heart rhythm (QT interval prolongation) with the use of over-the-counter...-
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Catalogue Entry: Summary Safety Review - MELATONIN (N-acetyl-5-methoxytryptamine) - Review of...
After becoming aware of international reports about neurological side effects, such as anxiety, panic reaction, visual hallucinations and seizures, possibly associated with...-
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Catalogue Entry: Summary Safety Review - Omnipod Insulin Management System - Assessing the...
In 2014, Health Canada completed a first safety review for the Omnipod because a high number of complaints, reporting high level of blood sugar (hyperglycemia), were received at...-
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Catalogue Entry: Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk...
A Health Canada safety review was carried out as a follow-up assessment on the potential risk of retinal detachment with the use of oral fluoroquinolones. Health Canada's...-
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