OBJECTIVES :

To analyse the adverse reactions that occurred with the two main drugs used in the context of the COVID-19 disease - Hydroxychloroquine (1^st pandemic wave) and Remdesivir (2^nd pandemic wave) - based on notifications of adverse reactions from Portugal.

METHODS :

We conducted a retrospective, observational study on the Portuguese Pharmacovigilance System database, between 03/2020 and 12/2020. We selected Adverse Drug Reactions (ADR) reports that contained Hydroxychloroquine and Remdesivir as suspected drugs and excluded reports that contained more than one drug as suspected of causing ADR. The analyses performed for each drug under study were as follows: (1) seriousness, (2) type of ADR – Preferred Term hierarchy level coding, according to the MedDRA, (3) description of ADR in the SmPC and (4) characteristics of the patient (age and sex).

RESULTS :

Of the 147 ADR reports, 61 (41.5%) are to Hydroxychloroquine, and 87 (58.5%) are to Remdesivir. Regarding the seriousness criteria, there was a percentage of seriousness reports above 80% in both groups. For Hydroxychloroquine, the five most frequent ADRs were: cholestasis (23.2%), hepatocellular injury (14.7%), condition aggravated (8.4%), pancytopenia (4.2%) and QT prolonged electrocardiogram (4 .2%). 90% of these ADRs are described in the SmPC. Looking at Remdesivir, the five most frequent ADRs were: increased transaminases (21.7%), renal impairment (9.6%), alanine aminotransferase increased (7.0%), blood creatinine increased (4.35%) and bradycardia (4.35%). Regarding the description of ADRs for this drug in the SmPC, only 38% are described. For both drugs, male patients are the ones who have more ADR (54% for Hydroxychloroquine and 68% for Remdesivir), and the average age is higher in patients taking Hidoxychloroquine (68 years; SD 16 years) than in patients taking Remdesivir (62 years; SD 18 years).

CONCLUSIONS

Our results show how real-world data can increase awareness of drugs' safety profile, especially drugs with new therapeutic indications.