Zantac is an anti-acid drug available over the counter and with a prescription. In its OTC form, it treats heartburn and acid indigestion. In prescription strength, it treats ulcers, GERD and erosive esophagitis. It starts to work in as little as 30 minutes and can last up to 12 hours. Potential drug interactions include warfarin, ketoconazole and atazanavir.
The antacid Zantac — known as ranitidine in generic form — is available over the counter or as a prescription. People can take the drug orally in pill and liquid form or intravenously as an injection.
GlaxoSmithKline first received FDA approval for Zantac in 1983, and by 1988 it was the world’s best-selling drug, bringing in $1 billion in annual sales.
Currently, Sanofi markets brand-name Zantac in the United States. In 2018, the company reported it made roughly $124 million in the United States.
According to Bloomberg Intelligence, nearly 25 million prescriptions for ranitidine were written in 2018.
Zantac side effects are typically mild and pass quickly. The most commonly reported adverse events include constipation, diarrhea and nausea or vomiting. Rarely, some serious side effects such as skin rashes, liver failure and cardiac disorders may occur.
In April 2020, the U.S. Food and Drug Administration requested manufacturers of Zantac and its generic forms withdraw all prescription and over-the-counter versions of the drugs immediately over concerns of contamination with N-Nitrosodimethylamine, or NDMA, a chemical impurity that could cause cancer.
Source: U.S. Food and Drug Administration
While the Agency for Toxic Substances and Disease Registry doesn’t have adequate studies to show how exposure to NDMA in food or drink may affect humans long term, evidence shows NDMA can cause cancer and death in animals. It is also very toxic to the liver in animals and humans.
In a public health statement, the agency said, “Although there are no reports of NDMA causing cancer in humans, it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.” Exposure to NDMA doesn’t necessarily lead to health problems.
Organs potentially affected by NDMA include the bladder, brain, liver, kidneys, lungs and stomach, according to a report by the World Health Organization.
In December 2019, Congresswoman Rosa L. DeLauro urged the FDA to remove ranitidine from shelves and ban all sales in the United States because of the cancer risk.
Starting on Sept. 24, 2019, some manufacturers began voluntary Zantac recalls of certain lots of the drug because of contamination with N-nitrosodimethylamine, or NDMA — a chemical that may cause cancer.
At first, the agency didn’t agree that NDMA levels present in ranitidine were too high. But after preliminary testing of some drug samples, on Oct. 2, 2019, the FDA stated that contamination levels were “unacceptable.”
On Nov. 1, 2019, the agency announced that it had found NDMA in all the drug samples it tested. It determined that “the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
The FDA set the daily acceptable limit for NDMA consumption at 96 nanograms — 0.32 parts per million, or ppm. It recommended that all manufacturers with levels above this limit recall their products.
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