Health Canada

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...

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. The review was triggered by 3 scientific studies which observed that following injection into the eye, Eylea is removed...

A safety review was conducted to evaluate the potential link between Abilify and Abilify Maintena (aripiprazole) and certain behaviours where individuals cannot control their urges (impulse control behaviours): uncontrollable gambling (pathological gambling) and sexual behaviours (hypersexuality).

This safety review was carried out by Health Canada after the publication of case reports of IAS (insulin autoimmune syndrome) causing hypoglycemic episodes linked with the use of oral alpha lipoic acid products in individuals with a genetic variation which causes the body's own defence system to...

Health Canada carried out this safety review when it became aware that the FDA was investigating the risk of angle-closure glaucoma linked to antidepressant use. Angle-closure glaucoma is a serious eye disorder where eye fluid drainage is blocked, leading to a sudden increase in the pressure in...

Health Canada reviewed the potential risk of DRESS with the use of atypical antipsychotics, following the manufacturers’ voluntary update of the product safety information for Zyprexa (olanzapine) and Zeldox (ziprasidone) to include the risk of DRESS (Drug Reaction with Eosinophilia and Systemic...

Health Canada carried out a safety review to look into the risk of sleep apnoea with the use of atypical antipsychotics. Sleep apnoea is a disorder that causes breaks in breathing or shallow breaths during sleep. This review was triggered by the submission of new safety information from the...

Health Canada reviewed the potential risk of SW and SRED with the use of atypical antipsychotics, following the publication of a case report describing these events in a patient treated with ziprasidone. Sleep walking is a sleep disorder that causes people to get up and walk or do other complex...

Health Canada carried out a safety review to look into the use of atypical antipsychotics and the potential risk of having difficulty urinating or not being able to fully empty the bladder (urinary retention). This can be an emergency that requires medical attention. This review was triggered by...

Health Canada reviewed the potential risk of colitis with Aubagio use after finding reports (since being marketed) of colitis as part of routine review of information received from the manufacturer. Also, the product safety information of a closely-related drug, Arava (leflunomide) was updated to...

The Canadian product safety information for lorazepam and midazolam warn that they should not be used during pregnancy. The Canadian product safety information for phenobarbital warns that during pregnancy the drug’s benefit should be weighed against its risk. Also, restrictions for use in...

Health Canada reviewed the potential risk of severe bone damage (osteonecrosis) with bisphosphonate use because of product information updates in Europe that warn about the risk of severe bone damage in the outer part of the ear canal. Previously, Health Canada completed a safety review of the...

Health Canada has completed a safety review on the potential risk of BIA-ALCL, following an increase in the number of cases reported internationally. The review analysed the available information on the Canadian rate of BIA-ACL (the number of confirmed cases of BIA-ALCL reported in relation to...

Health Canada carried out a safety review of all the available evidence to evaluate the risk of side effects related to heart and stroke linked with celecoxib, in comparison to other NSAIDs (diclofenac, ibuprofen, naproxen).

Clozapine is a prescription drug authorized for sale in Canada to manage symptoms of schizophrenia when other drugs have not helped. Clozapine was developed in the 1960s. In 1975, clozapine was removed from the Canadian market because of reports of life-threatening infections and deaths linked...

Codeine is converted to morphine in the liver. Some people have genetic variations of liver enzymes which cause codeine to be converted to morphine faster and more completely than in other people. These people with genetic differences (ultra-rapid metabolizers) are more likely to have higher than...

In 2013 and 2015, Health Canada carried out safety reviews on codeine-containing products as they relate to the risk of potentially life-threatening breathing problems. At the time, it was recommended that codeine-containing products no longer be used in children under 12 years of age. New safety...