PRAC New Risks from Drugs - September 2024 Update
Here’s the latest on emerging drug safety signals identified by the Pharmacovigilance Risk Assessment Committee (PRAC):
1️⃣ Medroxyprogesterone Acetate
PRAC identified a new safety risk with high-dose medroxyprogesterone acetate, commonly used for contraceptive and oncological purposes. Long-term use of high doses has been associated with an increased risk of meningioma (a type of brain tumour). PRAC recommends that patients with a history of meningioma should not use this medication unless it's needed for cancer treatment. Healthcare professionals are advised to closely monitor patients on this medication for symptoms such as headaches, vision changes, or seizures(
European Medicines Agency (EMA)
2️⃣ Metamizole and Agranulocytosis
The use of metamizole, a painkiller, has been linked to agranulocytosis, a potentially life-threatening drop in white blood cells. PRAC advises healthcare professionals to ensure patients are aware of early symptoms like fever, sore throat, and mucosal changes. If agranulocytosis is suspected, treatment must be stopped immediately(
European Medicines Agency (EMA)
3️⃣ 5-Fluorouracil (5-FU) and DPD Deficiency
PRAC also flagged the chemotherapy drug 5-fluorouracil (5-FU), which poses a risk of severe toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for this enzyme deficiency is crucial, but PRAC warns that results should be interpreted cautiously in patients with renal impairment(
European Medicines Agency (EMA)
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