Current information on the safety of medicinal products

Important information on the risks of using medicinal products containing retinoids by women of childbearing potential and pregnant women

Important information on the risks of using VALPROATES in women of childbearing potential and pregnant women

Health Canada has published information on a new safety issue: dopamine agonist withdrawal syndrome

This information is published for the purpose of awareness and to encourage reporting of similar adverse reactions. Key messages Withdrawal syndrome of agonists…

Health Canada and the US Food and Drug Administration (FDA) have published new safety information on COVID-19 vaccines: the risk of myocarditis and pericarditis

Key messages Cases of myocarditis and pericarditis after immunization with COVID-19 vaccines have been registered in Canada and other countries. These messages…

The Ministry of Health of Canada (Health Canada) has published new information on the AstraZeneca COVID-19 Vaccine and COVISHIELD: risk of capillary leak syndrome

This safety issue has already been highlighted by the European Medicines Agency (EMA); in particular, a communication to healthcare professionals has been published (https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vaxzevria-previously-covid-19-vaccine-astrazeneca_en-1.pdf)…

The U.S. Food and Drug Administration (FDA) reports that studies have revealed an increased risk of heart rhythm problems in patients with heart disease taking the medicinal product lamotrigine (Lamictal)

A review of study results conducted by the FDA showed a potentially increased risk of heart rhythm problems (arrhythmias) in patients with heart disease,…

Risk of blood clots associated with thrombocytopenia after vaccination with AstraZeneca COVID-19 vaccine in the EU. Comments of the State Expert Center of the Ministry of Health of Ukraine.

According to global regulatory agencies, AstraZeneca COVID-19 Vaccine and CHADOX1 NCOV-19 CORONA VIRUS VACCINE (RECOMBINANT), COVISHIELD / CHADOX1 NCOV-19 CORONA…

Overview of recommendations on signals considered by the PRAC at its meeting on 8-11 February 2021

The PRAC concluded that the use of Veklury (remdesivir) is not associated with kidney problems. The PRAC has completed its review…

Analysis of reports from applicants on cases of adverse reactions associated with the use of medicinal products in the treatment of COVID19 that were received by the Center during December 2020

During December 2020, the Center received information on 13 cases of adverse reactions during the use of medicinal products (hereinafter –…

Medicinal products containing bacitracin in the form of solution for injection (50000 IU per vial) and the risk of nephrotoxicity and anaphylactic reactions – recommendations of Health Canada

Key messages Serious cases of nephrotoxicity and hypersensitivity, including allergic contact dermatitis and/or anaphylaxis, have been reported in patients receiving medicinal…