Summary Safety Review - BRILINTA (ticagrelor) - Assessing the Potential Risk of Severe Skin Side Effects

June 26, 2017

Product

Brilinta (ticagrelor)

Potential Safety Issue

Severe skin side effects (Severe cutaneous adverse reactions, SCAR) which include: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis.

Key Messages

  • Brilinta is a prescription drug that is authorized for sale in Canada and used with low-dose aspirin (acetylsalicylic acid) to reduce the risk of having a stroke, having another heart attack or dying from a disease related to the heart or blood vessels.
  • Health Canada reviewed the risk of severe skin side effects (SCAR) after an increase in the number of SCAR reports was seen in the safety information provided by the manufacturer.
  • Health Canada's review concluded that there was not enough information available to confirm a link between the risk of SCAR and the use of Brilinta. Health Canada will continue to monitor this risk.

Overview

Health Canada reviewed the potential risk of SCAR associated with the use of Brilinta because there was an increase in the number of reports severe skin reactions, which require hospitalization and can be sometimes be fatal.

Use in Canada

  • Brilinta is a prescription drug that is authorized for sale in Canada and used with low-dose aspirin (acetylsalicylic acid) to reduce the risk of having a stroke, having another heart attack or dying from a disease related to the heart or blood vessels.
  • Brilinta is available as a tablet.
  • Although not commonly prescribed, Brilinta use has steadily increased since it became available on the Canadian market in June 2011.

Safety Review Findings

  • At the time of the review, Health Canada had received 2 Canadian reports of SCAR associated with the use of Brilinta. Of these 2 reports, 1 was found to show a possible link between SCAR and the use of Brilinta, which means that the drug was 1 reason among others that could explain why SCAR happened. The second report was left out because it did not present symptoms of SCAR.
  • The safety review also looked at 40 international reports of SCAR associated with the use of BRILINTA. In 4 of the 40 reports, there was considered to be a possible link between SCAR and the use of Brilinta.
  • In the literature reviewed, there was no evidence of increased risk of SCAR with the use of Brilinta.
  • The product label for Brilinta does not mention a risk of SCAR. However, less severe skin reactions such as rashes are included in the product label.

Conclusions and Actions

  • Health Canada's review concluded that there was not enough information available to confirm that there is a link between the risk of SCAR and the use of Brilinta.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this health product.
  • Health Canada will continue to monitor side effects involving Brilinta, as it does for all health products on the Canadian market, to identify and assess potential harms.  Health Canada will take appropriate and timely action if and when new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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