Real-world repurposing of off-patent drugs for off-label use can provide immediate treatment options for COVID-19 patients who have no time to wait.

Key Messages

During global or individual health emergencies where no approved treatments are available, off-label drug use (also called “real-word drug repurposing”) may offer the only hope for a treatment or cure.

COVID-19 causes a broad disruption of physiological functions to affect multiple organs in the body. Therefore, drugs that are capable of targeting multiple physiological disruptions are essential for treating the disease.

Famotidine, which is sold over-the-counter (without a prescription) is approved for treating heartburn caused by acid reflux disease, but it has powerful effects on the immune system.

Famotidine has broad antiviral activities, lowers blood pressure, protects the heart, reduces inflammation and inhibits excessive blood clotting.

The multi-target activities of this drug, in addition to its well-established, 40 year history of safe use make famotidine an optimal candidate as an off-label drug to treat COVID-19.

JMIR Public Health and Surveillance

Publication Date: April 7, 2020
Peer Reviewed: Yes
Publication Type: Original | Theoretical

Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point

Moshe Rogosnitzky, Esther Berkowitz, Alejandro R Jadad


Real-world drug repurposing-the immediate “off-label” prescribing of drugs to address urgent clinical needs-is a widely overlooked opportunity. Off-label prescribing (ie, for a nonapproved indication) is legal in most countries and tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, health crises may mean that real-world repurposing is the only realistic source for solutions. Optimal real-world repurposing requires a track record of safety, affordability, and access for drug candidates. Although thousands of such drugs are already available, there is no central repository of off-label uses to facilitate immediate identification and selection of potentially useful interventions during public health crises. Using the current coronavirus disease (COVID-19) pandemic as an example, we provide a glimpse of the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and targeted toward the underlying pathophysiology that makes COVID-19 so deadly. This paper briefly summarizes why cimetidine or famotidine, dipyridamole, fenofibrate or bezafibrate, and sildenafil citrate are worth considering for patients with COVID-19. Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our health care systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.