Zantac Recall and Ranitidine Injuries

Boston Attorneys Now Reviewing Cases for Patients Who Used Zantac or Ranitidine Medications and Suffered Illness or Complications

Breakstone, White & Gluck of Boston is reviewing cases for patients who have suffered serious illness or complications from the heartburn drug Zantac (ranitidine) or generic versions. Patients should no longer take ranitidine – which was sold over-the-counter and by prescription – because of concerns it contains a chemical which could cause cancer.

After a months-long investigation, the Food and Drug Administration (FDA) formally requested the removal of all ranitidine products from the market on April 1, 2020. With this action, ranitidine will no longer be available for new or existing prescriptions or over-the-counter use in Massachusetts or across the U.S.

This action affects patients of all ages, including adults, teenagers and children. Patients may have received the medication as a tablet, syrup or by injection or IV in a hospital setting.

Background on Ranitidine Market Withdrawal

Ranitidine belongs to a class of medications known as H2 blockers, which reduce the amount of acid produced in the stomach. It was widely used to treat ulcers of the stomach and intestines and prevent them from recurring.

The FDA issued its first warning in September 2019, announcing that testing had found low levels of N-Nitrosodimethylamine (NDMA) in ranitidine. At that time, the FDA said ranitidine patients may want to look for an alternate treatment, but that there was not enough scientific evidence to advise patients against ranitidine use.

In response, Sanofi, the manufacturer or Zantac, recalled the medication in October 2019. These included the Zantac 150, Zantac 150 Cool Mint and Zantac 75 (OTC Products).

Several other ranitidine manufacturers followed, including:

• Dr. Reddy’s Laboratories Ltd. (manufacturer for these brand names: Dr. Reddy, Kroger and Walgreens)
• American Health Packaging (AHP brand name)
• Aurobindo & DG Health
• Lannett Company, Inc.
• Novitium Pharma
• Perrigo Company plc
• Apotex Corp.
• Sandoz Inc. (a division of Novartis)
• Appco Pharma LLC (ani brand name)
• Glenmark Pharmaceuticals
• Amneal Pharmaceuticals
• Precision Dose
• GSMS Incorporated

FDA Withdrawal Request on April 1, 2020

On April 1, 2020, the FDA asked manufacturers to remove all prescription and over-the-counter ranitidine drugs from the market immediately. New testing and information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions. They were found to increase significantly in samples stored at higher temperatures (which a product may be exposed to during distribution and handling by consumers). Older medications were also likely to contain higher levels of NDMA.

The notice: FDA Requests Removal of All Ranitidine Products (Zantac) from the Market, April 1, 2020.

NDMA and the Risk for Cancer

NDMA is an environmental contaminant which is also found in water and food, such as meat and dairy. But the FDA stated, “these low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans.”

People who have taken Zantac or other medications containing ranitidine may have been diagnosed with these cancers:

• Stomach cancer
• Bladder cancer
• Kidney cancer
• Pancreatic cancer
• Colon cancer
• Liver cancer
• Prostate cancer

In the April 1st notice, the FDA advised consumers to stop taking any Zantac or ranitidine products they may have in their homes and instead use other drugs to treat heartburn, such as Pepcid, Prevacid, Nexium or Prilosec. Patients were advised to consult their primary care physician before making any changes.

Free Legal Consultation – Boston Ranitidine (Zantac) Lawyers

Breakstone, White & Gluck is an award-winning Boston law firm which is recognized by Super Lawyers and the Best Lawyers in America. Our attorneys provide experienced representation in personal injury and product liability cases, including those involving unsafe medications and defective medical devices. Many patients long suffer without knowing the cause of their illness or injuries, until the FDA issues a recall or warning.

If you were treated with Zantac or another ranitidine product, you may have suffered illness or adverse symptoms as a result. Learn more about your injuries and your legal rights. Contact our attorneys for a free legal consultation at 800-379-1244 or use our contact form.