Page 2: Health Product InfoWatch – April 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.
Cardizem CD (diltiazem hydrochloride)
The risk of bronchospasm, including asthma aggravation, has been included in the Precautions and Adverse Reactions sections of the Canadian product monograph for Cardizem CD.
Key messages for healthcare professionals:Footnote 1
- Bronchospasm, including asthma aggravation, has been reported with the use of diltiazem, especially in patients with pre-existing bronchial hyper-activity and after dose increase.
- Patients should be monitored for signs and symptoms of respiratory impairment during diltiazem therapy.
- Footnote 1
Cardizem CD (diltiazem hydrochloride) [product monograph]. Laval (QC): Valeant Canada LP; 2018.
Vaccine safety biannual summary
Health Canada and the Public Health Agency of Canada (PHAC) share the responsibility of monitoring the safety of vaccines in Canada.
Market authorization holders are required to report serious adverse events following immunization (AEFIs) to the Canada Vigilance Program in Health Canada. The Canada Vigilance Program also receives voluntary AEFI reports from healthcare professionals and consumers.
Provincial and territorial public health authorities report AEFIs from publicly funded vaccine programs to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) in PHAC to monitor the safety of immunization programs.
Report for January 1, 2017 to June 30, 2017
This biannual vaccine safety summary includes AEFI reports received by the Canada Vigilance Program between January 1, 2017 and June 30, 2017. To access reports published by CAEFISS, please visit the CAEFISS Web site.
- From January 1, 2017 to June 30, 2017, the Canada Vigilance Program received 222 reportsFootnote * of adverse events following immunization for which vaccines were the suspected cause.
Total number of AEFI reports received, by type of originating reporter
Figure 1 - Text Equivalent
The figure shows the total number of AEFI reports received from January 1, 2017 to June 30, 2017, by type of originating reporter.
|Other health professional||20.45|
|Consumer or other non health professional||16.36|
Total number of AEFI reports received, by age group
Figure 2 - Text Equivalent
The figure shows the total number of AEFI reports received from January 1, 2017 to June 30, 2017, by age group and severity:
|Age||Serious||Number of reports|
|Infant (28 days to 23 months)||No||3|
|Infant (28 days to 23 months)||Yes||9|
|Child (2-11 years)||No||7|
|Child (2-11 years)||Yes||25|
|Adolescent (12-18 years)||No||5|
|Adolescent (12-18 years)||Yes||4|
|Adult (19-64 years)||No||35|
|Adult (19-64 years)||Yes||46|
|Elderly (≥ 65 years)||No||27|
|Elderly (≥ 65 years)||Yes||20|
- There were 142 (64%) serious reports. Most of these involved patients with underlying medical conditions and were unlikely related to the vaccination.
- The highest number of reports (serious and non-serious) involved herpes zoster vaccine (22%) and influenza vaccines (21%), followed by pneumococcal vaccines (18%).
- The most frequently reported adverse events (serious and non-serious) included drug ineffectiveness, injection site erythema, pruritus, pyrexia, and injection site swelling. These are common adverse events following vaccination and are captured in the Canadian product monographs.
- In cases that reported drug ineffectiveness, the information provided was not sufficient to adequately assess the causal association with the vaccine because one or more elements of the following information was not reported: vaccination according to the recommended schedule, pre-existing condition at the time of vaccination, concomitant treatment(s), laboratory test to confirm the serotype, and time to onset.
- No new safety signals (potential safety issues) were identified during this period.
- The benefits of vaccines authorized in Canada continue to outweigh the risks.
- Health Canada, in collaboration with the Public Health Agency of Canada, will continue to closely monitor the safety of vaccines authorized in Canada and will take appropriate action if any new health risks are identified.
For additional information, contact the Marketed Health Products Directorate.
Note that because of updated information received by the Canada Vigilance Program, there may be differences in the number of AEFI reports and adverse events retrieved at different dates.
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