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The FDA recently added famotidine to its list of drug shortages.
The FDA recently added famotidine to its list of drug shortages1,2, just a week after Science Magazine reported on a clinical trial in which patients with severe coronavirus disease 2019 (COVID-19) were receiving intravenous famotidine, the active compound in the OTC heartburn drug Pepcid.3
However, short supplies of the drug date back to when recalls of ranitidine products began late last year.
Science reported that 187 patients with COVID-19 in critical condition, including many on ventilators, were enrolled in the trial at Northwell Health in the New York City area. "Reports from China and molecular modeling results suggest the drug, which seems to bind to a key enzyme in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), could make a difference,” the journal said.3
There is still no evidence that famotidine is effective against COVID-19.
Community pharmacists told Drug Topics® that the COVID-19 clinical trial is likely not the root cause. The ranitidine recalls that began late last year triggered the famotidine shortage, they said.
“I had to order it at Amazon a couple of months ago because we can’t get it in our store,” Kyona Nason, PharmD, a pharmacist for a national drugstore chain, told Drug Topics®. "It’s been a problem for months since the various ranitidine recalls.”
“We have had issues since before ranitidine, but they are way worse now,” said Alexsis Williams, PharmD, pharmacist in charge at a national drugstore chain. “I was checking out the expected dates manufacturers think they will have it back in stock….some said June, some said December.”
Last month, the FDA requested that manufacturers of all ranitidine drugs remove their products from the market.
According to ASHP, Bausch has short-dated Pepcid 20 mg tablets in 30- and 100-count bottles and 40 mg tablets in 30-count bottles with an expiration date of March 2021. Teva has all famotidine tablets on back order, with an estimated release date of 4th quarter of 2020.4
1. FDA Drug Shortages. FDA; May 5, 2020. Accessed May 7, 2020. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Famotidine%20Injection&st=c
2. FDA Drug Shortages. FDA; May 4, 2020. Accessed May 7, 2020. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Famotidine%20Tablets&st=c
3. Borrell B. New York clinical trial quietly tests heartburn remedy against coronavirus. Science. April 26, 2020. doi:10.1126/science.abc4739
4. Famotidine tablets. ASHP; May 6, 2020. Accessed May 7, 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=616