Safety Consequences of Off-Label Drugs Used for COVID-19

During a global emergency, making clever use of existing resources is a fundamental human impulse. But, the cavalier repurposing of hydroxychloroquine, chloroquine, and azithromycin during the COVID-19 pandemic has consequences.

Seven deaths from cardiac adverse events occurred with the off-label use of drugs whose power to prevent COVID-19 has been discredited.

A review article was published in springer on the safety Consequences of Off-Label Drugs Used for Covid19. The data come from a real-time global database of side effect reports that each pharmaceutical company is legally required to maintain. The Pfizer database was used in this study.

Each report was medically assessed to establish the strength of the causal connection between the medication and the reported side effect.

Pfizer presented 1508 cases gathered during the first 8 months of the pandemic, mainly involving immunosuppressant/immunomodulating agents and anticoagulant/antithrombic agents, as well as corticosteroids were the most frequently reported pharmacotherapies; antibiotics and antimalarial agents were the two most commonly reported off-label pharmacotherapeutic classes.

One-third of all off-label use reports came from France. Despite the global scope of the database, reports were most frequently from the USA, France, and Spain and may not be globally representative.

Most of the adverse events involved concomitant use of multiple medications, making it inherently difficult to disentangle individual drug effects. Half of the patients had underlying conditions that might predispose them to infection or the negative consequences of infection.

Reference:

https://link.springer.com/article/10.1007%2Fs40264-020-01035-x

https://link.springer.com/article/10.1007%2Fs40264-021-01056-0


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