A recent meeting of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) referred to adverse events associated with COVID-19 vaccines and with nomegestrol or chlormadinone.
There have been reports of meningioma with nomegestrol- or chlromadinone-containing medicines, indicated in women for various uses. New data from two epidemiological studies in France led to a review request by the French medicine agency. The EMA's safety committee will examine the evidence, and make recommendations regarding marketing authorisation amendments.
Review of cases of venous thromboembolism (VTE) in patients who received Janssen's COVID-19 vaccine concluded that there is a possible link. The committee recommended that VTE is listed in the product information as a rare side effect, with warnings to raise awareness in healthcare professionals and patients.
Similarly, the agency conducted a review of cases of immune thrombocytopenia (ITP) with Janssen's COVID-19 vaccine and AstraZeneca's COVID-19 vaccine [Vaxzevria]. The committee recommended that the product information for both vaccines is updated in include ITP as an adverse reaction with unknown frequency, and to highlight that low platelet levels have been reported within the first 4 weeks postvaccination. A direct healthcare professional communication (DHPC) will be issued for each vaccine.
Reference
- European Medicines Agency (EMA). Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021. Internet Document : 1 Oct 2021. Available from: URL: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-27-30-september-2021