This overview is intended primarily for healthcare professionals. It provides a brief summary of key medicinal product safety information published in November 2022 by the Ministry of Health of Canada (Health Canada). The published information is not exhaustive.
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, as well as what is known about the use of medicinal products both in Canada and abroad.
Health Canada has published information on amendments to the package inserts of medicinal products containing valacyclovir
Corresponding changes were made to the sections “Special warnings and precautions for use” and “Adverse reactions” (adverse reactions reported during post-registration surveillance) for medicinal products containing valacyclovir, taking into account the risk of drug-induced eosinophilia with systemic symptoms (DRESS syndrome).
Key messages for healthcare professionals:
- DRESS syndrome has been reported in connection with treatment with valacyclovir. DRESS syndrome is a severe skin reaction that can affect one or more organs and can be life-threatening or lead to a fatal outcome.
- Patients should be closely monitored for skin reactions and informed about the signs and symptoms of DRESS syndrome, including fever, rash, skin peeling, facial swelling, lymphadenopathy, flu-like symptoms, jaundice, shortness of breath, dry cough, chest pain or discomfort, dehydration and eosinophilia.
- If signs and symptoms suggestive of DRESS syndrome appear, valacyclovir should be discontinued immediately and alternative treatment should be considered.
- If a patient develops DRESS syndrome while taking valacyclovir, treatment with valacyclovir must not be resumed under any circumstances.
The original text of this publication can be found at the link:
