Zantac is the brand name for the drug ranitidine. Ranitidine belongs to a class of drugs called histamine-2 blockers, which relieve and prevent heartburn, as well as ulcers in the stomach or intestines. In addition to brand name Zantac, many companies sell generic versions of the drug. Unfortunately, despite the popularity of this heartburn drug, Zantac has been recalled.

Why was Zantac recalled?

Zantac has been recalled due to a contamination of NDMA. NDMA may cause harmful side effects, including stomach cancer, in humans who consume it. Although NDMA is a common environmental contaminant that people may come into contact with by eating dairy products, vegetables, or grilled or smoked meats, the chemical compound is capable of resulting in adverse side effects if it is consumed in high amounts.

When was Zantac recalled?

The U.S. Food and Drug Administration (FDA) announced the Zantac contamination on Sept. 13, 2019. In the months since the FDA’s initial report and ranitidine recall, multiple drug companies have announced additional recalls of the drug.

What Zantac has been recalled?

In addition to brand name Zantac, generic Zantac has been recalled by Walgreens, Walmart, and Rite-Aid. Other companies that have recalled ranitidine include Apotex, Sandoz, Appco Pharma, Northwind Pharmaceuticals, American Health Packaging, Dr. Reddy’s Laboratories, Perrigo Company, Aurobindo, and more.

The FDA has recommended companies recall their ranitidine tablets if testing indicates contamination levels higher than the acceptable daily intake for NDMA. This acceptable intake level is 96 ng, or 0.32 parts per million. Additionally, some companies that have tested ranitidine and found levels below the acceptable daily intake have still recalled the medications, due to the potential for further contamination. However, the FDA does not recommend patients stopping use of their medication without first visiting with their doctor.

If you are concerned that you may have purchased recalled ranitidine or brand name Zantac, you may be able to check the FDA’s drug recall page and compare your lot numbers against the recalled lots.

How did the Zantac contamination occur?

Concerns about Zantac recalled prompted experts to seek more information about the possible contamination. Zantac’s contamination might not be because NDMA got into batches of Zantac, according to Deseret News. Rather, experts believe that under certain circumstances, Zantac itself may produce NDMA. Emery Pharma conducted a study examining this phenomenon. The research showed that Zantac can convert into NDMA when the drug is exposed to high heat.

Chemist Ron Najafi summarizes, saying “NDMA in this case…is not an impurity in the drug. It’s being formed from the drug itself,” quotes Deseret. 

The amount of NDMA increases notably when the drug is heated up, CBS notes. When ranitidine is heated to 158 degrees, NDMA levels rose to 142 nanogram — well above the FDA’s daily acceptable intake limit of 96 nanogram of NDMA. Najafi notes that there are a range of seemly innocuous instances in which a drug could be heated to 158 degrees. For instance, if a patient accidentally left their medication in their car on a hot summer day, the drugs might reach 158 degrees fairly easily.

NDMA levels were seen to rise in ranitidine if it was left at room temperature for 12 days, says CBS, but much lower. After 12 days at room temperature, ranitidine’s NDMA levels reportedly increased to 25 nanograms per day. Happily, this is well below the FDA’s accepted level.

Though this new research provides valuable insight, Dr. Janet Woodcock, head of drug evaluation and research at the FDA, says there is much more to learn about ranitidine and NDMA. She says that researchers have yet to determine if the drug needs to be kept cold to prevent it from converting into NDMA. Another important piece of information that researchers do not yet have is whether or not the drug can convert into NDMA once ingested, explains CBS. 

What are the side effects of NDMA?

NDMA (N-Nitrosodimethylamine) has been classified as a probable human carcinogen, after testing done on animals showed that NDMA exposure may result in the development of tumors. In addition to the possible increased cancer risk related to NDMA exposure, the chemical compound may result in other health consequences.

Side effects of NDMA exposure may include jaundice, nausea, fever, abdominal cramps, vomiting, headache, fever, and dizziness. Additional long term side effects may include damage to the kidneys, lungs, and liver.

If you have consumed Zantac recalled by Sandoz, Apotex, or another pharmaceutical company and have suffered from side effects related to NDMA exposure, you may qualify to have an attorney review your case.

Zantac alternatives

When the FDA required Zantac recalled from the shelves, it reportedly began testing other heartburn medications containing ranitidine, according to Cardiovascular Business News, and found similar problems. Consumers who use heartburn medications may want to consider alternatives, as a result.

Other heartburn medications that do not carry the same NDMA risks include Pepcid, Nexium, Prevacid, Prilosec, and Tagamet, according to Prevention. There are also a number of dietary changes consumers can make to help manage heartburn, says the publication. These changes include reducing intake of the following foods and beverages:

• Caffeine
• Alcohol
• Citrus fruits
• Chocolate
• Hot sauce
• Onions
• Black pepper
• Tomatoes

WebMD talked to experts who recommended lifestyle changes to help manage heartburn without the use of medications. Experts recommend those who suffer heart burn consider losing weight and eat less at mealtimes or split meals. They also say that those who suffer from heartburn should eat more slowly.

Heartburn suffers can also try and make sure they don’t go to bed with a full stomach. According to WebMD, eating two or three hours before sleeping can help food digest and be less likely to cause acid to flow upwards when settling down to sleep. In addition, for those that experience heartburn when they lay down, blocks can be placed under the head of the bed to raise it. Experts say that laying on pillows doesn’t work because the angle can cause pressure on the stomach, resulting in worse heartburn.

Experts also told WebMD that those suffering from heartburn should consider keeping track of when the condition hits to try and identify triggers to be able to avoid them later.

Have Zantac lawsuits been filed?

Sanofi and other manufacturers face numerous lawsuits over the carcinogen found in Zantac and its generic alternatives. Plaintiffs in some cases claim they were injured by exposure to NDMA while others allege cancer stemming directly from the medication.

In April, a man from Washington filed a lawsuit against Zantac manufacturers claiming that he developed bladder cancer after taking the medication. The plaintiff allegedly took Zantac since November 2009 and regular used the medication until Zantac recalls in October 2019. In July 2020, the man was diagnosed with bladder cancer. According to the plaintiff and his wife, this bladder cancer diagnosis was a direct result of long term Zantac use.

Sanofi also faces allegations of an intentional cover-up. In a May filing, lawyers accused the company of “widespread” destruction of employee emails. The emails allegedly pertained to the company’s 2019 Zantac recall. According to court filings, this alleged email tampering delayed lawsuit proceedings.

If you or someone you love has been diagnosed with cancer after Zantac use, you may be able to file a lawsuit and pursue compensation. Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.