When Medications Harm
When Medications Harm
Joy Stepinski, RN-BC
August 10, 2025
Medications seem to work miracles when people are not feeling well or have a certain condition to treat. Have a headache? Pain? Nausea? Diarrhea? Diabetes? Depression? Urinary problems? Obesity? Arthritis? High blood pressure? Heartburn? Medications are advertised to help the symptoms of any ailment. Yet what happens when drugs that have been marketed for years are pulled from shelves due to medical harm?
Such is the case with a very familiar drug called Zantac. Zantac was a well-known medication classified as a histamine-2 receptor blocker, used for the treatment of gastrointestinal disorders, such as gastroesophageal reflux disease (GERD), heartburn, duodenal ulcers, and esophagitis [1]. In 1983, the Food and Drug Administration (FDA) approved the prescription drug for the treatment of ulcers, and subsequently other upper gastrointestinal problems. In 1995, the medication became available over the counter under the generic name of ranitidine. A prescription was no longer required. Developed by the British pharmaceutical company Glaxo, now GlaxoSmithKline, the drug was on the market for 35 years.
Glaxo initially marketed ranitidine as an improvement over Tagamet, a drug that reduces stomach acid to treat heartburn and reflux. In 1988, ranitidine became the world's bestselling prescription medication. Ranitidine was so successful that it topped $1 billion in sales, one of the first drugs to reach that achievement [2]. After the medication’s patent expired in 1997, Pfizer received approval to sell the drug over-the-counter. Other pharmaceutical companies started manufacturing ranitidine.
In 2019, an online pharmacy called Valisure submitted a citizen petition to the FDA. According to that organization, the process allows individuals or consumer groups to petition the FDA to take action regarding a regulation [3]. In this case, Valisure claimed that there were high levels of N-Nitroso dimethylamine (NDMA) in Zantac and generic versions of the drug.
Taking a look back through history, Glaxo knew that there was a problem with the drug as early as 1982 [5], before the medication was even on the market. Revealed by the company’s then-rival, Smith, Kline & French, who produced Tagamet, Zantac formed a poisonous chemical when combined with nitrite. The rival company named the chemical NDMA. A Glaxo employee replicated the problem. Perhaps an even bigger finding was that NDMA formed when ranitidine itself was exposed to heat and humidity. This problem could also occur at room temperature. According to court documents, the company held this information in secret.
One of the problems with Zantac included discoloration. The white tablets would turn yellow or brown, indicating that the product was degrading. To hide the color change, the company elected to produce the medication in a pink color. Other problems with the drug’s color persisted when the injectable solution also turned yellow. At the time, investigators did not test for NDMA.
The problem with NDMA is that it is known as a cancer-causing compound. According to the National Library of Medicine [5],t health effects are numerous. In a wide range of animals, NDMA caused severe liver injury, fetal death, and various cancers. The authors related that human occupational exposure to NDMA caused liver, gastric, bladder, and prostate cancers; leukemia; and multiple myeloma. When NDMA was found in food, such as processed food, gastric and colorectal cancers were linked.
While litigation is ongoing, the FDA announced in 2020 that all prescription and over-the-counter ranitidine drugs were to be removed from the market [6]. The agency stated, “If a company can show, through scientific data, that their ranitidine product is stable and the NDMA levels do not increase over time to unsafe levels, FDA may consider allowing that ranitidine product back on the U.S. market.” GlaxoSmithKline has settled $2.2 billion in approximately 80,000 lawsuits [7], and other pharmaceutical companies have also reached settlements.
The FDA reports that the amount of NDMA increases over time when ranitidine is exposed to just room temperature [6]. Temperature can raise the levels of the carcinogen. This would have affected the storage of the medication, including the transportation of the drug, time on the shelves, and how the medication package was maintained in the home. Because Zantac was one of the most successful drugs, this issue potentially has affected millions of people. How many people were truly harmed?
For nurses, medication harm deeply affects the core of ethical principles. Among these is non-maleficence, meaning to do no harm to the patient. Nurses know that safety in care is paramount. As one article discusses, medication errors can be traumatizing [8]. When harm occurs, common feelings among healthcare staff are “guilt, shame, anger, fear, and anxiety” (p. 2) because nurses feel a deep burden of responsibility. Moral distress can ensue. If NDMA was a known problem since the drug first came on the market, non-disclosure was criminal. Healthcare providers prescribed the drug, and nurses administered Zantac without knowledge of the detrimental harm caused.
For patients, the Zantac saga breaks public trust. As the Centers for Disease Control and Prevention (CDC) state, “there are risks to taking any medicine, vitamin, or other supplement” [9]. Although the medication may be deemed safe, all drugs have known side effects and potential to harm.
When taking medication, some points to consider are:
Be fully informed. Know the potential side effects and adverse reactions that may occur. Understand that serious harm could potentially result that was not disclosed.
Reflect on underlying causes for the health condition, such as nutrition, stress, or other lifestyle factors. For example, in a study of 1,077 Italian participants, researchers concluded that a vegan diet may be a first-line therapy approach for gastroesophageal reflux disease (GERD) [9]. This type of diet is high in plants while avoiding high-fat animal-based foods.
If a medication is necessary, start with the lowest dose possible [10]. Be aware of the expiration date and any storage-related instructions.
The pharmaceutical company Sanofi reformulated Zantac in 2021. Instead of ranitidine, famotidine is now the active ingredient. Famotidine is found in the heartburn medication Pepcid. The reformulated drug is called Zantac-360, with the setback of NDMA almost disappearing from thin air.
Yet the fact that the former Zantac was life-threatening has serious consequences for consumers. As such, staying fully informed when making one’s medical decisions is paramount. Know that with any medication, there is a risk that may negatively impact your health. Consider all options, even non-pharmaceutical treatments. Carefully weigh your options and make decisions that reflect your values. Your health is an indispensable part of you!
References:
Delaware Superior Court. (2024). In re Zantac (Ranitidine) Litigation, C.A. No. N22C-09-101 ZAN. https://law.justia.com/cases/delaware/superior-court/2024/n22c-09-101-zan.html
CBC. (2019). How Zantac went from world’s best-selling drug to being pulled from store shelves. https://www.cbc.ca/news/health/zantac-heartburn-timeline-1.5330575
U.S. Food & Drug Administration (2025). CDRH Petitions. https://www.fda.gov/about-fda/cdrh-foia-how-get-records-cdrh/cdrh-petitions
Edney, A., Berfield, S., & Feeley, J. (2023). Zantac’s maker kept quiet about cancer risk for 40 years. The Journal of Advanced Practice Nursing. https://www.asrn.org/journal-advanced-practice-nursing/2906-zantac%e2%80%99s-maker-kept-quiet-about-cancer-risks-for-40-years.html
National Library of Medicine. (2023). Toxicological profile for N-Nitrosodimethylamine (NDMA). Agency for Toxic Substances and Diseases. https://www.ncbi.nlm.nih.gov/books/NBK601157/
U.S. Food & Drug Administration. (2020). Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac). https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac
OpenClassActions.com. (2025). What's the Zantac Class Action Settlement? https://openclassactions.com/settlements/zantac-ranitidine-gsk-class-action-settlement.php
Mahat, S., Rafferty, A.M., Vehviläinen-Julkunen, K. et al. Negative emotions experienced by healthcare staff following medication administration errors: a descriptive study using text-mining and content analysis of incident data. BMC Health Serv Res 22, 1474 (2022). https://doi.org/10.1186/s12913-022-08818-1
Rizzo, G., Baroni, L., Bonetto, C., Visaggi, P., Orazzini, M., Solinas, I., Guidi, G., Pugliese, J., Scaramuzza, G., Ovidi, F., Buselli, I., Bellini, M., Savarino, E. V., & de Bortoli, N. (2023). The role of a plant-only (vegan) diet in gastroesophageal reflux disease: online survey of the Italian general population. Nutrients, 15(22), 4725. https://doi.org/10.3390/nu15224725
Worst Pills, Best Pills. (n.d.). Ten rules for safer drug use. The Public Citizen. https://www.citizen.org/article/ten-rules-for-safer-drug-use/