Health Canada

Summary Safety Review - Over-the-Counter Products Containing Pseudoephedrine - Assessing the Potential Risk of Inflammation and Injury of the Large Intestine due to Insufficient Blood Supply (ischemic colitis)

Health Canada reviewed the potential risk of impotence (erectile dysfunction) with the use of oral retinoids because of a publication from the Netherlands that linked isotretinoin use with this side effect.Footnote1 Health Canada also reviewed the related evidence regarding all oral retinoids...

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 previous safety review examined the risk of retinal detachment with oral fluoroquinolones and had concluded that limited...

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 the time of the review. The review did not find a need for additional safety measures and recommended to actively...

After becoming aware of international reports about neurological side effects, such as anxiety, panic reaction, visual hallucinations and seizures, possibly associated with melatonin use in children and adolescents ranging from newborn to 18 years old (pediatric population), Health Canada did a...

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 (OTC) drug products containing loratadine. This safety review was triggered by a publication, in the World Health...

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 interaction between the two drugs may lead to higher amount of methotrexate in the blood, which may cause serious side...

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 suggested that digoxin use may be linked with a higher risk of death when compared to patients not using digoxin, especially...

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 Canada assessed the risk of acute kidney injury, which is defined as a sudden loss of kidney function, including kidney...

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, mainly in the fingers and toes, where they episodically do not receive enough blood and oxygen. The resulting lack 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 been actively monitoring reports of IOL glistening since 2012, with additional safety reviews completed in May 2015 and...

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 abnormal changes in the electrical activity of the heart, such as QT interval prolongation.

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. Health Canada’s safety review activities on hydrocodone further studied the risk of serious breathing problems in...

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, including a recent report in Canada.

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 part of this monitoring and when cases of side effects after vaccination with Gardasil were reported in early 2015....

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 accumulate in the brain when GBCAs are given repeatedly. The neurological effects of these build-ups are not known.

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 opioid. While reviewing safety information given by the manufacturer for this change, Health Canada found cases of respiratory...

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 were persistent (lasting 30 days or longer after stopping use of fluoroquinolones) and disabling side effects linked to the...

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 Canada's routine monitoring activities but there was not enough information to draw a conclusion about the potential risk.

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 Propecia and Proscar. The safety review focussed on potential risks of serious muscle-related adverse events such as...