On April 1, 2020, the Food and Drug Administration (FDA) issued a recall of all prescription and over-the-counter ranitidine drugs. This included the brand name medication Zantac, which is commonly used to treat heartburn, stomach ulcers, acid reflux, and gastroesophageal reflux disease (GERD). Here is what you need to know about the recall.
1. Why Was Zantac Recalled?
The Zantac recall is linked to independent laboratory testing conducted in the summer of 2019. According to the FDA, those tests found low levels of N-Nitrosodimethylamine (NDMA) in drugs that contain ranitidine. NDMA is a probable human carcinogen, which means it could cause cancer. While NDMA is commonly found at low levels in food and water, exposure to high levels over time may increase cancer risk.
At the time, the FDA didn’t have enough evidence to issue a recall, but they warned consumers of potential risks from ranitidine and recommended that patients consider alternative medications.
Recently, the FDA discovered that NDMA levels can increase when Zantac is exposed to high temperatures, or even under normal storage conditions. High temperatures might occur during normal distribution and handling of the medication. The FDA also found that the older Zantac is, the higher the levels of NDMA it contains. These factors led to the April 1 recall, as stated in the FDA’s press release.
2. Does Zantac Cause Cancer?
There is not enough data to determine whether Zantac causes cancer. However, it might increase cancer risk when taken over a long period of time if there are high levels of NDMA present. As the FDA stated, distribution and handling conditions, as well as the length of time a product has been on the shelf, can raise NDMA to unsafe levels.
3. Do Other Heartburn Drugs Cause Cancer?
As of April 1, the FDA has not found NDMA in other popular heartburn medications, including:
- Famotidine (Pepcid)
- Cimetidine (Tagamet)
- Esomeprazole (Nexium)
- Lansoprazole (Prevacid)
- Omeprazole (Prilosec)
According to the FDA, these drugs are safer alternatives for treating heartburn, stomach ulcers, acid reflux, or GERD.
On April 16, Amneal Pharmaceutical voluntarily recalled nizatidine oral solution because the medication may contain unsafe levels of NDMA. Nizatidine is a prescription drug used to treat ulcers and GERD.
Blood Pressure Drugs that Contain NDMA
Some blood pressure drugs have also been found to contain NDMA. In June 2018, Valsartan was recalled due to the presence of NDMA. The FDA investigated other drugs similar to Valsartan and found that some irbesartan and losartan products contained a different carcinogen known as N-Nitrosodiethylamine (NDEA).
4. What Should I Do if I’m Taking Zantac or Another Drug with Ranitidine?
If you are using an over-the-counter ranitidine medication, stop taking it immediately. If you have a prescription, do not stop taking your medication without consulting your doctor. Ask your primary care provider (PCP) about safer alternatives.
Find discounts on Rx medications for heartburn, acid reflux, and other conditions.
It’s important to monitor the FDA’s website for the latest information on drug recalls to keep yourself safe and informed. Your doctor and pharmacist also monitor the latest drug safety information and can be a resource for you.