Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024:

• Medroxyprogesterone: increased risk of meningioma with high doses and after prolonged use
  
  The PRAC has agreed a direct healthcare professional communication (DHPC) to inform healthcare professionals of the increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥100 mg oral formulations), primarily after prolonged use (several years). 
   
• Medicines for chemotherapy containing 5-fluorouracil (5-FU): in patients with moderate or severe renal impairment, phenotyping for dihydropyrimidine dehydrogenase (DPD) deficiency by measuring blood uracil levels should be interpreted with caution.
  
  The PRAC has agreed a DHPC to inform healthcare professionals about the fact that if blood uracil levels are used to determine the DPD phenotype, the phenotype result must be interpreted with caution in patients with moderate or severe renal impairment, as renal impairment can lead to increased blood uracil levels.

Once adopted, the DHPCs for medroxyprogesterone and 5-fluorouracil will be disseminated to healthcare professionals by the marketing authorisation holders, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.