On April 1, 2020, the Food and Drug Administration announced that all manufacturers of Zantac and/or generic Zantac over-the-counter medications, are to immediately withdraw their products from the marketplace.
The Food and Drug Administration determined that N-Nitrosodimethylamine (NDMA) in some drugs that contain ranitidine “increases over time when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…” NDMA is a known carcinogen.
What Exactly is Zantac and the Cancer Scare About?
Valisure, an online pharmacy, in 2019 did testing on Zantac and other products that contain ranitidine using methods that are approved by the Food and Drug Administration. In all the lots that Valisure tested, they found abnormally high levels of NDMA.
In fact, their testing showed that, on average, greater than 2,600,000 ng of NDMA was present in one Zantac 150 mg tablet. According to the Food and Drug Administration, the permissible daily limit is 96 ng of NDMA. This means that Zantac had NDMA levels approximately 28,000 times the legal limit.
To put it in perspective, someone would have to smoke over 500 cigarettes to have the same levels of NDMA as one Zantac 150 mg tablet.
Why Is There A Recall on Zantac?
As mentioned above, Valisure’s testing showed exceedingly high levels of NDMA in Zantac. As a result, many generic drug manufacturers and retailers voluntarily issued Zantac recalls.
Additionally, on January 2, 2020, Emery Pharma, a research laboratory, filed a citizen’s petition with the Food and Drug Administration after their tests showed that Zantac is time and temperature-sensitive and can develop NDMA when exposed to a heat source.
In their citizen’s petition, Emery Pharma suggested that all sales of ranitidine and Zantac should be recalled.
Which Zantac Products Are Recalled?
Below is a list of all of the companies that have issued Zantac (ranitidine) recalls even before the Food and Drug Administration issued their “market withdrawal” announcement.
- American Health Packaging
- Amneal Pharmaceuticals
- Aurobindo Pharma USA
- Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and 150 mg,
labeled by Walgreens, Walmart, and Rite-Aid)
- Appco Pharma
- Denton Pharma (dba Northwind Pharmaceuticals)
- Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines
labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
- GlaxoSmithKline (GSK)
- Glenmark Pharmaceuticals
- Golden State Medical Supply
- Lannett Company
- Novitium Pharma
- Perrigo Company
- Precision Dose
- Sandoz
- Sanofi
Could Zantac Be Contaminated?
As of now, we know of no known impurities or contaminants during the manufacturing that is responsible for the issues with Zantac.
When Zantac was recalled in April of 2020, the Food and Drug Administration used the term ‘impurity’ when they were referring to the NDMA in ranitidine. However, the Zantac attorneys at The Jeffcoat Firm know this is a mischaracterization of the problem, which is that Zantac is a dangerous and defective drug that can cause cancer.
What is NDMA?
NDMA is short for N-Nitrosodimethylamine is an organic chemical that is semi-volatile and forms in natural and industrial processes. It was formerly used in the production of lubricants and softeners for copolymers and antioxidants, and rocket fuel. NDMA today is used exclusively in the United States for research purposes only.
Both the World Health Organization, the Food and Drug Administration, and the Environmental Protection Agency have all classified NDMA as a carcinogen.
What Cancers Can Be Associated With Zantac?
The Jeffcoat Firm in Columbia, South Carolina have clients who have been diagnosed with the following types of cancer after taking Zantac/ranitidine:
- Bladder Cancer
- Esophageal Cancer
- Gastric Cancer
- Liver Cancer
- Pancreatic Cancer
If you aren’t sure you qualify to file a Zantac lawsuit, give us a call, and we will review your individual case for free.
Do You Think I Should Stop Taking Zantac/Ranitidine?
The Zantac attorneys at The Jeffcoat Firm do recommend that you stop taking Zantac/ranitidine and consult with your doctor about finding a safer alternative.
Is There A Dosage of Zantac That Is Considered Safe?
The short answer is No. Due to the high levels of NDMA found in Zantac, you shouldn’t be taking this medication. There are several safe alternatives, and you should talk to your health care provider.
What Are The Most Common Side Effects Associated With Zantac/Ranitidine?
In adults, some of the most common side effects of taking ranitidine include but aren’t limited to:
- Atrioventricular Block
- Blurred Vision
- Bradycardia
- Cholestatic Hepatitis
- Constipation
- Dizziness
- Extreme Fatigue
- Headaches
- Hepatitis
- Infection
- Infectious Diarrhea
- Insomnia
- Jaundice
- Liver Failure
- Pneumonia
- Premature Ventricular Beats
- Rashes
- Tachycardia
- Thrombocytopenia
- Unusual Bruising/Bleeding
- Vertigo
- Vitamin B12 Deficiency
Additionally, in elderly patients who are extremely sick, the side effects can include:
- Agitation
- Depression
- Hallucinations
- Mental Confusion
In children, the side effects may include:
- Constipation
- Diarrhea
- Headache
- Nausea
- Rashes
- Vomiting
If you or a loved one has taken Zantac/Ranitidine and developed cancer, you may be able to file a claim to receive monetary compensation for your damages. Please contact the Zantac lawyers at The Jeffcoat Firm so we can evaluate your case in a free consultation.
