Summary Safety Review - EFFIENT (prasugrel) - Assessing the Potential Risk of Severe Skin Side Effects
August 28, 2017
Potential Safety Issue
Severe skin side effects (severe cutaneous adverse reactions, SCAR) which include: Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis.
- Effient (prasugrel) is a prescription drug that is authorized for sale in Canada and used with low-dose acetylsalicylic acid, such as aspirin, to decrease 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 cases of this risk were reported by the manufacturer.
- Health Canada’s review concluded that there was not enough information available to establish a link between the risk of SCAR and the use of Effient. Health Canada will continue to monitor this risk.
Health Canada reviewed the potential risk of SCAR with the use of Effient because cases were reported by the manufacturer. The product safety information for Effient does not mention the risk of SCAR but includes less severe skin reactions such as rashes.
Use in Canada
- Effient is a prescription drug that is authorized for sale in Canada and used with low-dose acetylsalicylic acid, such as aspirin, to reduce the risk of having a stroke, having another heart attack or dying from a disease related to the heart or blood vessels.
- Effient was first marketed in Canada in 2010 and is available as a tablet.
- In 2016, approximately 28,000 prescriptions were filled in Canada.
Safety Review Findings
- At the time of the review, Health Canada had not received any Canadian reports of SCAR linked to the use of Effient.
- The safety review looked at 11 international reports of SCAR in patients treated with Effient. In 7 of the 11 reports, the link between SCAR and the use of Effient was considered to be possible; however other factors such as the advanced age of the patients and the use of other medications at the same time may have played a role. For the remaining 4 reports, the condition was considered unlikely linked to Effient use or there was not enough information to assess the link.
- In the literature reviewed, there was no evidence of increased risk of SCAR with the use of Effient.
Conclusions and Actions
- Health Canada’s review concluded that there was not enough information available to establish a link between the risk of SCAR and the use of Effient.
- 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 Effient, 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.
The analysis that contributed to this safety review included scientific and medical literature, 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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