PRAC review confirms chloroquine- and hydroxychloroquine-related AEs
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PRAC review confirms chloroquine- and hydroxychloroquine-related AEs In meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23–26 November 2020, the European Medicines Agency (EMA)’s PRAC has recommended updating product information for chloroquine and hydroxychloroquine with the risk of psychiatric disorders and suicidal behaviour after completing a review of chloroquine- and hydroxychloroquine-related adverse events (AEs). The review was initiated in May 2020 after the Spanish Medicines Agency informed the EMA of six cases of psychiatric disorders in patients with COVID-19 who received higher than authorised doses of hydroxychloroquine. Due to off-label use of these drugs in patients with COVID-19, the EMA reminded healthcare professionals during the pandemic that chloroquine and hydroxychloroquine have been reported to cause psychiatric disorders when used at approved dosages in authorised indications, and that psychotic disorders and suicidal behaviour are listed in product information as rare AEs, or AEs of unknown frequency, in patients with authorised indications. The review confirmed that psychiatric disorders have been reported in chloroquine- and hydroxychloroquinetreated patients with and without prior mental health disorders and were serious in some patients. AEs were reported within one month after initiating hydroxychloroquine. Immediate medical attention should be sought if patients receiving treatment with either chloroquine or hydroxychloroquine experience AEs such as irrational thoughts, hallucinations, confusion, anxiety, depression, suicidal ideation or thoughts of self-injury. EMA. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020 Internet Document : 27 Nov 2020. Available from: URL: 803520524 https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-23-26-november-2020
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Reactions 12 Dec 2020 No. 1834
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