The FDA announces Zantac recalls due to cancer concerns linked to bladder, liver, and stomach cancers found in people taking Zantac, a popular drug used to relieve heartburn.
Zantac Linked to Cancer
Zantac, known as ranitidine in generic form, has been recalled by the U.S. Food and Drug Administration (FDA). Based on FDA laboratory test results, ranitidine contains low levels of a nitrosamine impurity (NDMA), a known human carcinogen. As a result of FDA findings, Zantac has been pulled from store shelves at pharmacies, drug stores, and retail stores across the country.
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For years. the FDA has been investigating NDMA found in certain batches of blood pressure and heart failure medicines which prompted federal recalls. In 2019, NDMA was discovered in certain batches of ranitidine drugs, commonly taken to treat heartburn and ulcers. In addition to potentially causing cancer in humans, FDA research shows that overexposure to NDMA can cause vomiting, fever, jaundice, arrhythmia, and nervous system disorders.
Zantac is the most widely used heartburn drug in America. Doctors write more than 15 million prescriptions for the Zantac each year, and countless more patients buy it over the counter. Prescription Zantac is available in oral tablets and capsules, an oral liquid, and an injectable solution, while over-the-counter Zantac is sold mostly in tablets.
The FDA warns that people should not consume more than 96 nanograms of NDMA per day, but lab test results found more than 3,000,000 nanograms in some Zantac tablets. In April 2020, the FDA announced that ranitidine presents a public health risk to consumers and requested that manufacturers of ranitidine products remove all Zantac prescription drugs and over-the-counter drugs from the market.
Zantac Lawsuits on the Rise
Since news of Zantac recalls and links to cancer became public, Zantac cancer attorneys have seen thousands of lawsuits filed against ranitidine manufacturers. People who took Zantac and developed cancer have filed personal injury lawsuits. People who took Zantac and did not become ill have filled class action lawsuits. In both cases, injury claims allege that Zantac manufacturers were aware of potential NDMA cancer-causing risks, but failed to warn the public.
In 2019, the first class action Zantac lawsuit was filed in California against manufacturers Sanofi and Boerhringer Ingelheim. The lawsuit alleges dangerous levels of NDMA in a single Zantac pill that far exceeds the FDA acceptable levels for safe daily intake, resulting in the potential for cancers of the bladder, liver, stomach, pancreas, and colon, as well as internal bleeding, and death.
With a rise in Zantac lawsuits across the country, Sanofi and Boerhringer Ingelheim have recalled all Zantac over-the-counter drugs in the United States and Canada. Major U.S. retailers that sell Zantac including Target, Walgreens, and CVS have removed all Zantac products from shelves until further notice.
In most states, the law allows people who developed cancer after taking Zantac to file a personal injury lawsuit with a Zantac cancer attorney. Injury victims can recover the maximum possible compensation for medical expenses, lost wages and future earnings, pain and suffering, temporary or permanent disability, and other compensable damages, including punitive damages in some cases.
People who have taken Zantac, but show no signs of developing cancer, can file class action lawsuits through a Zantac cancer attorney to recover money spent on Zantac drugs during their course of treatment.
Why Zantac Drugs Have Been Recalled
The FDA has issued a national recall of all Zantac drugs due to a carcinogenic ingredient known to cause cancer in humans.
FDA Recalls Zantac Drugs
Due to mounting consumer complaints and national lawsuits filed with Zantac cancer attorneys, the Federal Food and Drug Administration (FDA) has issued a national recall of Zantac, a popular drug used to treat heartburn and acid reflux problems in adults and some children with active intestinal ulcers. Alarming testing data shows a possible link to Zantac and certain cancers of the stomach, liver, bladder, pancreas, and colon.
The FDA is concerned about alarming test results that link ranitidine products (known by the brand name Zantac) to certain cancers in humans. Testing shows unacceptable levels of NDMA, a probable carcinogen (cancer-causing chemical), found in some ranitidine products. The levels of cancer-causing chemicals in Zantac have been found to be between 3,000 and 26,000 times higher than the levels determined to be safe by the FDA.
Ranitidine is a drug that’s available in a prescription version and an over-the-counter version. Prescription ranitidine comes as an oral tablet, oral capsule, oral syrup, and an injectable solution. Over-the-counter Zantac comes in an oral tablet and a liquid.
Zantac is usually prescribed for short periods of time, but some people with stomach ulcers and gastrointestinal disorders take it for longer periods. FDA testing shows that NDMA impurity levels increase significantly when ranitidine products are stored over time or at higher temperatures, including high temperatures products may be exposed to during distribution by retailers and handling by consumers. Testing also shows that ranitidine products with older manufactured dates show much higher levels of NDMA.
In 2020, the FDA requested all manufacturers of Zantac to recall both prescription and over-the-counter drugs from the market immediately. Major retailers and pharmacies including Kroger, Target, Walmart, CVS, Rite Aid, and Walgreens have pulled prescription and over-the-counter formulas of Zantac from their shelves. In addition, Sanofi, Zantac’s brand-name manufacturer, as well as 14 generic manufacturers have recalled the drug in the United States.
The FDA is advising consumers who take over-the-counter Zantac to stop taking any medications they currently have, and seek other drugs approved for the same or similar uses without possible cancer risks. Patients taking prescription Zantac or other ranitidine products are advised to consult with their doctor for a safe drug replacement without personal injury risks from NDMA impurities found in Zantac.
Illinois Woman Sues Zantac for Gastric Cancer
After taking over-the-counter Zantac drugs for eight years, an Illinois woman has filed a lawsuit alleging Zantac caused her to develop stomach cancer.
Gastric Cancer Linked to Zantac Lawsuit
Recent cancer links to Zantac, a popular heartburn medication, have put a national spotlight on the safety of the drug. Due to consumer concerns and numerous lawsuits, the U.S. Food and Drug Administration (FDA) has recalled Zantac drugs and asked all manufacturers and retailers to stop selling all forms of Zantac products.
In a recent lawsuit, an Illinois woman blames the use of Zantac for her gastric cancer. In 2019, the woman received a medical diagnosis of gastric cancer, a type of stomach cancer that forms malignant cells in the stomach lining, then produces tumors in the outer layers of the stomach. The woman says she began taking over-the-counter Zantac tablets in 2000 to relieve heartburn, and continued to take them through 2018, following all of the directions on the package.
The lawsuit alleges that a common ingredient, N-nitrosodimethylamine (NDMA), used in Zantac (a brand name) and ranitidine products (generic brands) are known to be a probable human carcinogen by the US Environmental Protection Agency. NDMA was previously used to make rocket fuel. Today, it is used in scientific research labs to induce cancerous tumors in test animals. NDMA has been detected in some blood pressure and diabetes medications, but in low amounts. It has been detected in ranitidine products (generic Zantac) in amounts 3,000 times higher than the approved safety level by the FDA. Zantac products are available in both prescription and over-the-counter drugs, but the highest levels of NDMA have been found in ranitidine generic drugs.
NDMA was first discovered in Zantac in June 2019 by an online pharmacy doing random testing. Research showed that ranitidine molecules are unstable and break down during digestion in the human stomach, forming NDMA particles. The pharmacy submitted a petition to the FDA in September 2019, urging a recall of all forms of ranitidine products.
The FDA followed up with its own testing of Zantac and generic ranitidine and found unacceptable levels of NDMA. The FDA called on manufacturers to investigate concerns with their own testing and voluntarily recall products. In January 2020, the FDA issued a national recall of all Zantac and ranitidine products. Over the last year, ranitidine cancer lawyers have witnessed rising personal injury lawsuits and class-actions against the makers of Zantac.