[Pharmacovigilance update]

Rev Med Suisse. 2021 Jan 13;17(720-1):80-84.
[Article in French]

Abstract

The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19: relatively safe but turns out to be less effective than expected. Hydroxychloroquine in COVID-19 : lack of efficacy and risk of arrhythmias. Cytokines storm in COVID-19: may impact pharmacokinetics. VEGF inhibitors: risk of aneurysm and artery dissection. Tofacitinib: dose-dependant risk of venous thromboembolic events. Ondansetron in the first trimester of pregnancy : a highly debated risk of orofacial cleft defects. Fingolimod : contraindicated during pregnancy due to suspected risk of congenital malformations. Ranitidine: global market withdrawal due to contamination with nitrosamines. Ulipristal for uterine fibroids : market withdrawal due to risk of severe liver injury. Ingenol mebutate : market withdrawal due to paradoxical risk of skin cancers.

Les principales actualités de pharmacovigilance 2020 sont passées en revue. Remdésivir et Covid-19 : moins efficace qu’attendu mais assez sûr. Hydroxychloroquine et Covid-19 : absence d’efficacité et risque d’arythmies. Orage cytokinique et Covid-19 : impact possible sur les paramètres pharmacocinétiques. Inhibiteurs du VEGF : risque d’anévrisme artériel et de dissection. Tofacitinib : risque d’événements thromboemboliques. Ondansétron au 1er trimestre de grossesse : risque controversé de fentes palatines. Fingolimod : contre-indiqué dans la grossesse pour possible risque malformatif. Ranitidine : retrait du marché mondial pour contamination par des nitrosamines. Ulipristal et fibromyomes utérins : retrait du marché pour risque d’atteinte hépatique grave. Mébutate d’ingénol : retrait du marché pour risque paradoxal de cancers cutanés.

Publication types

  • Review

MeSH terms

  • Adenosine Monophosphate / analogs & derivatives
  • Adenosine Monophosphate / therapeutic use
  • Alanine / analogs & derivatives
  • Alanine / therapeutic use
  • COVID-19 Drug Treatment
  • Cleft Lip / prevention & control
  • Contraindications, Drug
  • Cytokine Release Syndrome / virology
  • Female
  • Fingolimod Hydrochloride / adverse effects
  • Humans
  • Hydroxychloroquine / adverse effects
  • Leiomyoma / drug therapy
  • Norpregnadienes / therapeutic use
  • Pharmacokinetics
  • Pharmacovigilance*
  • Pregnancy
  • Ranitidine / adverse effects
  • Safety-Based Drug Withdrawals
  • Skin Neoplasms / chemically induced

Substances

  • Norpregnadienes
  • remdesivir
  • Adenosine Monophosphate
  • Hydroxychloroquine
  • ulipristal
  • Ranitidine
  • Fingolimod Hydrochloride
  • Alanine