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.
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.
Coronavirus: reminder of risk of serious adverse effects associated with chloroquine and hydroxychloroquine
The European Medicines Agency (EMA) recommends that healthcare professionals monitor cardiac adverse effects and consider pre-existing heart conditions in COVID-19 patients treated with hydroxychloroquine or chloroquine. It should also be borne in mind that there may be an increased risk of cardiac adverse effects when these treatments are administered in high doses or in combination with certain medicinal products, such as azithromycin.
Flash VIG-news: risk of haemolysis associated with the use of hydroxychloroquine (PLAQUENIL) in the treatment of COVID-19
Physicians should be alert to the signs and symptoms of haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency treated with hydroxychloroquine for the treatment of COVID-19.
Flash VIG-news: pay attention to the elimination half-life of hydroxychloroquine and chloroquine and to the risks of drug interactions
As mentioned in the AFMPS news of 24.03.2020, hydroxychloroquine (Plaquenil) and chloroquine are used in certain circumstances to treat patients with COVID-19. The FAMHP reminds everyone of the risks of drug interactions posed by these treatments.
Coronavirus: hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) are subject to controlled distribution in Belgium to enhance monitoring of treatments
Hydroxychloroquine, chloroquine and Kaletra (lopinavir & ritonavir) are used to treat patients with COVID-19. The FAMHP has quarantined available stocks of these medicines to control their distribution, improve monitoring of their use and limit the risks to patients. Do not take any of these medicines without medical supervision.