On April 1, 2020, the US Food and Drug Administration requested that the manufacturers of Zantac remove all of their products from the market. FDA testing showed that the medication contained a cancer-causing contaminant. The removal request requires manufacturers to ensure the removal of over-the-counter and prescription-grade products from their shelves. Prior to the April order, drug manufacturers had already initiated recalls. Pharmacies and other retailers pulled the products from their shelves after a September 2019 FDA product alert.
The alert and recalls follow the FDA ‘s determination that Zantac and some of its generic equivalents contain varying levels of the nitrosamine contaminant, NDMA. This contaminant is known to cause cancer and testing showed that some levels were far higher than allowed by the FDA. Similar contamination issues generated a January 2019 product recall of Angiotensin II Receptor Blocker (ARB), a class of drugs prescribed for high blood pressure. At that time, the FDA recalled prescription drugs, Valsartan, Losartan, and Irbesartan, due to high levels of NDMA and/or NDEA. Both are known carcinogens.
Drug Manufacturers Should Protect Their Customers From Harm
At Allan Berger & Associates, we believe that drug manufacturers should pay for the harm they cause. Glaxo Smith Kline, Sanofi, and other pharmaceutical companies have earned huge profits from Zantac and other consumer drugs. The consumers who use these and other products have the right to feel confident that their medications are safe. Manufacturers have failed in this critical duty. If you have sustained injuries as a result of their failures, the attorneys in our Pharmaceutical and Product Device Liability Practice Group want to help.
What is Zantac?
Zantac is a treatment for digestive disorders. The drug reduces the stomach’s acid production. It also prevents and treats heartburn, ulcers, and gastroesophageal reflux disease. While the drug was originally dispensed by prescription only, it gained approval as an over-the-counter drug in the UK in 1995. The FDA approved OTC use in the United States in 2004.
Sanofi currently produces the over the counter medications sold in the United States. Glaxo Smith Kline produces prescription varieties and an injection form sold in New Zealand. Since its initial introduction, the drug has been produced by Glaxo Holdings Ltd, GlaxoSmithKline PLC, Pfizer, Johnson & Johnson, and Boehringer Ingelheim Pharmaceuticals. Walgreens, Rite Aid, and other stores market their own branded versions of ranitidine.
What is Ranitidine?
Zantac is a brand name for the drug, ranitidine. FDA tests showed that ranitidine contained the contaminant, N-nitrosodimethylamine otherwise known as NDMA, a known carcinogen. It’s also found in small amounts in beer and nitrite-cured meats such as bacon. Research by the World Health Organization determined that NDMA is also a contaminant in some water supplies.
Research has shown that NDMA also causes liver damage and other adverse medical conditions in animals. It’s also known in some circles as an effective poison. One example is an assault committed by one graduate student against another in 2018. Canada’s Global News reported that a Queen’s College student used NDMA in his ongoing attempts to poison a colleague. The student added daily doses of the contaminant and another substance in his victim’s food and water. He was eventually charged with multiple crimes, including assault.
The report, “Understanding and Preventing (N-Nitrosodimethylamine) NDMA Contamination of Medications,” discusses NDMA and its origins. The author, C Michael White of the University of Connecticut School of Pharmacy, explains that NDMA was once used during liquid rocket fuel production. It’s now a by-product of chemical reactions. It’s introduced into medication in several ways.
- Produced during the manufacturing process
- Introduced by contaminated ingredients
- From solvents or catalysts that are contaminated
White also found that the NDMA in ranitidine varied depending on the drug batch. He and others researching ranitidine determined that heat was a factor in its production. When testing subjects who had taken products containing NDMA, he couldn’t determine if their NDMA levels were a result of contamination in the drugs before ingestion or if it was produced during the digestion process. White found that ambient temperatures could transform ranitidine to NDMA during elevated heat situations such as delivery or storage.
A Recall Timeline
- September 13, 2019: The FDA issued its initial warning about ranitidine-containing products in their September 13, 2019 communication, “Statement alerting patients and health care professionals of NDMA found in samples of ranitidine.” The alert didn’t require manufacturers to recall their products.
- Beginning in late September, the FDA announced a series of voluntary recalls. Apotex, Dr. Reddy’s, Glenmark, Lannett, Sandoz, Perrigo and other manufactures recalled products containing ranitidine. Each manufacturer varied their parameters. Some recalled products “in all sizes and formats.” Others designated specific lots or “all but expired lots.”
- October 8, 2019, Prescription Zantac Manufacturer, GlaxoSmithKline, announced a recall and published a press release on October 24, 2019
- October 18, 2019, Zantac OTC manufacturer, Sanofi, responded to the FDA alert by announcing a “…precautionary voluntary recall of Zantac OTC in the U.S and Canada.“
- On April 1, 2020, the FDA issued the order, “FDA Requests Removal of All Ranitidine Products (Zantac) from the Market” The order confirmed that the products were a “…risk to public health…”
Customer Have Mixed Reactions and Reviews
Since retailers have removed the drug from pharmacies and shelves, customers have had mixed feelings about their acid-reducer of choice. The website Drugs.com shares a range of customer reviews. While some fret about losing access to their medication, others complain about the drug’s side effects. Users have experienced nausea, vomiting, headache, pain and many other symptoms. Some of the symptoms described are known side effects of NDMA ingestion.
Should You Throw Your Zantac Away?
The FDA Alert advised consumers that they should, “…stop taking any tablets or liquid they currently have, dispose of them properly and not buy more…” While this is sound advice, your package is proof that you took the medication. Instead of throwing it away, consider a safe storage alternative. Choose a cool, dry storage area that’s out of the reach of children. Excessive heat may alter the product’s composition.
While the legal future is uncertain for ranitidine drugs, the product in your possession is evidence. This is especially important with over-the-counter product versions. A doctor’s and pharmacy’s records should validate your prescription purchases. if you have no receipt, the package in your possession may be your only proof that you used the OTC version of the product.
Allan Berger & Associates Attorney at Law
Contact us if you or a family member have been diagnosed with cancer or have been affected in any way by Zantac or a ranitidine product produced by any other drug manufacturer. Our Pharmaceutical and Product Device Liability Practice Group would like to hear your story. For decades, our attorneys have fought to recover personal injury damages for our injured clients. Let us schedule a free consultation to see if we can help you. Call us at 504-618-1581 or complete our Contact Form.
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