Famotidine & Ranitidine

Drug News from Preferred Medical …

The FDA announced on April 1 it is “requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.” This includes the Zantac brand name variant, a popular drug used for stomach ulcers and conditions where the stomach produces excess acid. The FDA also recommends that patients stop taking any ranitidine medications immediately and properly dispose of any remaining tablets or liquid. The FDA continues by saying that patients “should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks.”

However, the process started in September 2019 when the FDA published their findings that products “contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen.” Shortly thereafter, major pharmacies around the country pulled ranitidine products from the shelves. All of that created an availability shortage for ranitidine products and a strain on the drug distribution system, which is understandable given the unfolding news.

Recently, availability shortages have started for a similar drug – famotidine (name brand Pepcid) – but for different reasons. On May 5 the FDA officially added famotidine to the Current Drug Shortages list. This is not due to any issues with the drug but with an April 27 Science Magazine report that a randomized, double-blind trial started on April 7 in New York City using intravenous famotidine to treat hospitalized patients with respiratory issues related to SARS-CoV-2 (i.e. the novel coronavirus currently ravaging the planet). There is no evidence that physicians are prescribing this as a therapy for COVID-19 patients beyond the clinical trial. This quote is interesting: “The potential for intravenous famotidine treatment for the novel coronavirus has been kept under wraps in order for the hospital system to be able to maintain a sufficient stockpile of the drug.” A clinical trial of in-patient intravenous famotidine affecting the availability of the tablet form is a somewhat irrational response. However, according to some community pharmacists, the evolving shortage of famotidine actually began in conjunction with the ranitidine recalls.

Whatever the reasons, two historically popular prescription and over-the-counter drugs used to help prevent and treat ulcers in the stomach and intestines are now hard to find. We will continue to monitor this evolving situation and how it impacts care provided to injured workers.