Background and importance The European list of medicines under additional monitoring (MUAM), identified with a black inverted triangle, includes new active substances, biological medicines, medicines that require a post-authorisation safety study, medicines approved conditionally or authorised under exceptional circumstances, and medicines authorised with specific obligations on the recording or monitoring of suspected adverse drug reactions (ADR). This list is reviewed monthly by the Pharmacovigilance Risk Assessment Committee (PRAC). A drug remains under additional monitoring for 5 years or until the PRAC decides to remove it from the list.
Aim and objectives To describe the ADR produced by MUAM.
Material and methods This was a descriptive, retrospective study in a second level hospital, from 2013 to 2018. The pharmacy service recorded and notified ADR due to MUAM to the pharmacovigilance centre (FC) after their detection spontaneously or from the complex analysis information system (CAIS). Once patients with ADR by MUAM were selected, the electronic medical history was reviewed: age, sex, medicines involved, type of ADR, detection method, admissions due to ADR, description in the data sheet and communication to the FC.
Results Forty-five ADR (from 26 medicines) were detected in 40 patients (57% men), who had a mean age of 65.8 years (26–84). Causative agents were: antineoplastics (80%); antianginals (4.4%); agents acting on the renin–angiotensin system (4.4%); and other (11.2%). The main ADR were febrile neutropenia (lenalidomide (n=2), palbociclib (n=2), ramucirumab (n=2), imatinib (n=1), brentuximab (n=2), nintedanib (n=1)); bradycardia (ivabradine (n=2), fingolimod (n=1)); hepatocarcinoma (ledipasvir/sofosbuvir (n=2)); thrombocytopenia (panitumumab (n=2), ibrutinib (n=1)); oliguric acute kidney injury (sacubitril/valsartan (n=2)); and vomiting (cabozantinib (n=2), alectinib (n=1)). Drugs with a higher incidence of ADR were: cabozantinib (vomiting (n=2), asthenia (n=1), osteonecrosis (n=1)); nivolumab (myocardial infarction (n=1), cerebral haemorrhage (n=1), pulmonary thromboembolism (n=1)) and regorafenib (hypertension (n=1), skin rash (n=1), hyponatraemia (n=2)). ADR detected by spontaneous notification: 77.8%. ADR caused hospital admission in 62.2% of cases (febrile neutropenia (28.6%)). ADR caused death in 3 patients (oliguric acute kidney injury due to sacubitril/valsartan (n=2) and myocardial infarction due to nivolumab (n=1)). ADR not described in the data sheet: 13.3%. ADR reported to the FC: 93.3%.
Conclusion and relevance Antineoplastic agents were the therapeutic group with the highest incidence of ADR. MUAM caused hospital admission in a high percentage of cases and were the cause of death in three patients. We found that 13.3% of ADR were considered new, so it is essential to continue reporting suspected ADR to gather new information to help define the safety profile of all medicines, especially MUAM.
References and/or acknowledgements No conflict of interest.
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