The FDA Just Told Manufacturers to Remove Ranitidine Drugs from Shelves

On April 1, 2020, the U.S. Food and Drug Administration (FDA) announced a total recall of all prescription and over-the-counter Zantac and other ranitidine-containing pharmaceuticals. The agency is concerned these products might be contaminated with N-nitrosodimethylamine (NDMA), a probable cause of bladder and stomach cancer. Patients who used the drug for a long time may be at risk.

Our experienced defective drug attorneys at Ashcraft & Gerel are investigating claims of contaminated Zantac. If you or a loved one took Zantac or another ranitidine-based pharmaceutical and were subsequently diagnosed with bladder or stomach cancer, call us at (866) 709-0505 today for a free case evaluation.

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What’s the Problem with Zantac (Ranitidine)?

In mid-2019, the FDA started testing Zantac after a third-party lab reported the medication was associated with higher NDMA levels in patients. Many drugmakers and stores recalled the products, saying they were likely contaminated during manufacturing.

On April 1, 2020, the FDA issued a market-wide recall after new evidence showed the NDMA contamination in Zantac (and other ranitidine drugs) was not due to a manufacturing error. In fact, NDMA was created by a reaction within the drug itself. Particularly, the FDA noted in its recall, if left sitting in ambient heat higher than room temperature, the drug may create and/or increase the NDMA impurity.

Even under recommended storage conditions, the drug could become dangerous; during distribution and handling, when exposed to higher temperatures, the rate of NDMA production was shown to increase. The test also showed the longer the time between drug manufacture and use, the greater the levels of NDMA. These conditions could cause the level of NDMA in the ranitidine product to surpass the acceptable daily intake limit. Beyond this heat-induced creation of NDMA, at least one manufacturer has also suggested contamination may occur when ranitidine comes into contact with water.

Beyond the FDA and pharmaceutical litigators like Ashcraft & Gerel, this problem is currently being investigated by a number of worldwide health agencies, including:

• Australia: The Therapeutic Goods Administration
• Canada: Health Canada (HC)
• European Union: European Medicines Agency (EMA)
• Germany: The Federal Union of German Associations of Pharmacists
• Italy: Italian Medicines Agency
• United Kingdom: Medicines and Healthcare products Regulatory Agency, and the Department of Health and Social Care

What Patients Should Know About Ranitidine

The medication has been on the market for over 30 years and is widespread in both brand-name and generic forms. Zantac and its analogues have been prescribed to many patients for long-term use. Unfortunately, repeated ingestion of ranitidine could have caused dangerous exposure to NDMA. If you

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What Is Zantac Prescribed For?

Zantac is primarily used to decrease stomach acid production, and is routinely prescribed for the treatment of:

• Peptic Ulcer Disease
• Gastroesophageal Reflux Disease (GERD)
• Zollinger–Ellison Syndrome

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Should I Stop Taking Zantac or Other Ranitidine Drugs?

Before making any changes to your medication use, we always suggest you consult with your physician to ensure your continued health and safety. However, we should note the guidance provided in the FDA’s most recent recall:

“The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.” (emphasis added)

Tests conducted by the agency have found similar drugs (Pepcid, Tagamet, Nexium, Prevacid, and Prilosec) do not pose the same risk as ranitidine medications.

Who Manufactures Zantac?

Brand name Zantac is currently owned and manufactured by Sanofi, a French pharmaceutical company headquartered in Paris. Before their acquisition of the brand name in 2016, the medication was made by Boehringer Ingelheim and GlaxoSmithKline.

Other current and former sellers and manufacturers of ranitidine and ranitidine-containing pharmaceuticals for consumer medical use include:

• Accord Healthcare
• American Health Packaging
• Amneal Pharmaceuticals
• Apotex Inc.
• Appco Pharma
• Aurobindo Pharma
• Creo Pharma Limited
• Dr. Reddy’s Laboratories
• Galpharm International
• Glenmark Pharmaceutical
• Golden State Medical Supply
• Medley Pharma Limited
• Medreich Plc.
• Northwind Pharmaceuticals
• Noumed Life Sciences
• Novitium Pharma
• Omega Pharma Limited
• OTC Concepts
• Perrigo Company
• Precision Dose
• Pro Doc Limitée
• Relonchem
• Rosemont Pharmaceuticals
• Sandoz Canada
• Sanis Health Inc.
• Sivem Pharmaceuticals
• Teva UK Limited
• Tillomed Laboratories

What Is NDMA?

NDMA is an organic compound that was identified by the International Agency for Research on Cancer (IARC) in 1987 as a probable cause of cancer in humans. The World Health Organization (WHO) and the FDA similarly assess NDMA as a cause of human cancer. When exposed to high amounts of the chemical at length, patients develop a risk for certain cancers.

What Types of Cancer Can NDMA Cause?

Because NDMA can enter the bloodstream and thus find its way to any organ, scientists are looking at potential links between the molecule and many types of cancer. So far, they have confirmed it can cause cancers of the:

• Bladder
• Stomach

Beyond Zantac (ranitidine), several other drugs have been investigated for NDMA contamination, including Valsartan (used to treat high blood pressure, heart failure, and kidney disease) and Metformin (used to treat type 2 diabetes and polycystic ovary syndrome).

We’re Here for Cancer Patients Who Took Ranitidine Medications

If you took Zantac or other ranitidine drugs and were later diagnosed with bladder or stomach cancer, you may be able to file a claim against the pharmaceutical company that made the medication. Our defective drug attorneys at Ashcraft & Gerel are investigating claims of contaminated ranitidine medications to help cancer patients pursue justice.

If you or a loved one took Zantac or another ranitidine-containing pharmaceutical and were subsequently diagnosed with bladder cancer or stomach cancer, call us today at (866) 709-0505 for a free case evaluation.