During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.
PRAC April 2021 – Conclusions and additional review on Vaxzevria (AstraZeneca’s COVID-19 vaccine), and new investigations on COVID-19 Vaccine Janssen
During its April 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded on very rare cases of unusual blood clots with low blood platelets reported with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and started reviewing a safety signal of capillary leak syndrome in patients vaccinated Vaxzevria. Furthermore, the PRAC is also investigating thromboembolic events reported following vaccination with COVID-19 Vaccine Janssen.
The FAMHP Medication errors working group has received 112 notifications of proven or potential errors since 2016. Thanks to these notifications, corrective or preventive measures were put in place, in collaboration with the pharmaceutical industry. The Agency encourages healthcare professionals and patients to report any actual or potential medication error.
From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.
PRAC September 2020 – Revocation of marketing authorisation of ulipristal acetate (Esmya) for uterine fibroids
During its meeting of September 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended the revocation of marketing authorisation of ulipristal acetate for uterine fibroids.
Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly to support hospitals facing difficulties with supplies of medicinal products used in the treatment of COVID-19 patients. In addition, given the specific context of use of these medicinal products, the FAMHP has ensured close monitoring of adverse reactions.
Coronavirus: hydroxychloroquine: off-label use strongly discouraged and new benefit-risk assessment for clinical trials
The new COVID-19 treatment recommendations from Sciensano strongly advise against any off-label use of hydroxychloroquine outside of a clinical trial. Applicants for ongoing clinical trials must also update their benefit-risk assessment and demonstrate to the FAMHP that their risk reduction strategies during the trial are sufficiently adequate.
The FAMHP restates the risks linked to the use of chloroquine and hydroxychloroquine to treat COVID-19 following the publication of a retrospective analysis of a patient monitoring register in the medical journal The Lancet on 22 May 2020. The analysis did not highlight any benefits from these drugs in patients with COVID-19 and revealed adverse cardiovascular effects.
PRAC May 2020 – New measures to avoid handling errors with Leuprorelin depot medicines and completion of signal evaluation for ibuprofen, ketoprofen and fixed-dose combinations
During its meeting of May 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines.
In order to help healthcare professionals and support hospitals in their processes, the FAMHP is publishing guidelines on changing consumables (filters, etc.) used in the ventilation of COVID-19 patients.