Why was Zantac Recalled In 2020?

Zantac, which alternatively goes by the generic name ranitidine, is a prescription medication used to treat heartburn. It is also available over the counter (OTC) for less serious forms of heartburn. Ranitidine products belong to a drug class known as histamine-2 (H-2) blockers. Doctors typically reserve prescription Zantac for people with ulcers of the intestines or stomach.

Multiple pharmaceutical companies sell both the brand name Zantac and the OTC version ranitidine. Some pharmaceutical companies may still attempt to sell the brand name and generic versions of Zantac despite findings by the United States Food and Drug Administration (FDA) that it contains a probable human carcinogen known to increase cancer risk.

When and Why Did the FDA Recall Zantac?

The FDA made its first announcement related to the safety of ranitidine products on September 13, 2019. At that time, the FDA informed the public that both the brand name and generic versions of the popular heartburn medication contained an impurity of nitrosamine. The name of the impurity is N-nitrosodimethylamine, more commonly referred to as NDMA. Although the NDMA tested at low levels, it is still a probable human carcinogen. NDMA occurs naturally in water and certain categories of food, including dairy products, meat, and vegetables.

After its initial announcement last September, the FDA did not immediately call on pharmaceutical companies to stop producing ranitidine products or retailers to stop selling them. Instead, it urged anyone taking Zantac or its generic equivalent to speak to their doctor about alternatives if they felt concerned. The FDA also recommended at that time that drug manufacturers test their ranitidine products to determine if they contained any unacceptable levels of NDMA and to send the samples directly to the Food and Drug Administration.

The first voluntary recall of Zantac occurred on September 24, 2019, when the FDA announced the Sandoz Company implemented a voluntary 14-day recall of 14 lots of prescription Zantac. Sandoz took this action after discovering NDMA in some of its heartburn medication made in capsule form. Within the next few weeks, retail drugstore giants CVS Pharmacy, Rite-Aid, Walgreens, and Walmart discontinued all sales of Zantac and any generic ranitidine products.

On November 1, 2019, the FDA released a report indicating that it had discovered NDMA ranging from 0.03 parts per million to 2.85 parts per million in 18 separate ranitidine products. When announcing these findings, the U.S. Food and Drug Administration stated the NDMA level was similar to what people might find in smoked or grilled meats.

On December 4, 2019, the FDA issued a recommendation to drug manufacturers to test all lots containing ranitidine products. The FDA also advised drug manufacturers not to sell any type of Zantac product if the amount of NDMA exceeded the acceptable daily intake and to inform the FDA of its actions. Several drug manufacturers voluntarily stopped creating ranitidine tablets voluntarily over the next several months. On April 1, 2020, the FDA issued a request for all manufacturers and retailers to discontinue producing and selling prescription ranitidine along with over the counter ranitidine.

How Can Ranitidine Drugs Harm People?

Most studies of NDMA have taken place with animals. Scientists and medical researchers currently classify NDMA as a probable human carcinogen based on animal studies since human studies have been extremely limited.

People who take prescription or OTC heartburn medication containing NDMA do not face any immediate health risks. The potential increased cancer risk does not come unless a person has had continuous exposure to NDMA at high doses over a period of several years. The FDA also discovered impurities of NDMA in certain prescription heart medications in 2018, which later prompted a recall of those products as well.

Symptoms Associated with Zantac-Related Cancer

The NDMA present in Zantac prescription and OTC products can increase the likelihood of developing several types of cancer. The most common cancer types related to high-dose or prolonged exposure to the probable human carcinogen NDMA include:

  • Bladder
  • Brain
  • Colorectal
  • Esophageal
  • Kidney
  • Liver
  • Lung
  • Nasal/Throat
  • Ovarian
  • Pancreatic
  • Prostate
  • Stomach
  • Testicular
  • Thyroid
  • Uterine

Although the symptoms you experience depend on the type of cancer you have, the following are some of the most commonly reported symptoms by people who took heartburn medication containing NDMA:

  • Back pain
  • Blood in stools
  • Change in bowel habits
  • Darker colored urine
  • Dizziness
  • Fatigue
  • Incontinence or urinary urgency
  • Lack of appetite
  • Nausea
  • Pain when urinating
  • Skin itchiness
  • Tar-like appearance to stools
  • Unintended weight loss
  • Vomiting
  • Yellow skin or eyes

If you have any of these symptoms and think you could have developed cancer due to prescription ranitidine or OTC ranitidine, please don’t hesitate to schedule an appointment with your regular doctor. After reviewing your symptoms and medical history, he or she may choose to send you to an oncologist for additional testing.

An oncologist specializes in cancer diagnosis and treatment. You may undergo imaging tests like an MRI or CT scan with an oncologist and complete blood and urine tests with your regular doctor. It is important to follow all health care recommendations if you do receive a formal diagnosis. If your testing comes back negative, the oncologist can help you understand your future risk of cancer and how to reduce it as much as possible.

How to Lower Your Risk of Cancer Caused by NDMA

Doctors typically prescribe brand name Zantac or recommend generic ranitidine for short-term use only. Even if you don’t have any cancer concerns, we recommend that you speak to your healthcare provider about possibly taking a different heartburn drug. Other heartburn medications and H2 blockers have only low levels of NDMA and do not contain the same impurities as ranitidine products.

Taking antacids instead of Zantac can help as can making some dietary changes. For example, limiting or eliminating fatty foods, spicy foods, and alcohol are common treatment options recommended by doctors who see patients with heartburn or stomach ulcers.