New Research: Brief Heat Exposure Increases Zantac Cancer Odds

Washington, DCEmery Pharma, a California-based testing laboratory has reported that Zantac appears to produce unacceptably high levels of cancer-causing N-Nitrosodimethylamine (NDMA) when exposed to heat for as little as five days. Brief periods of modestly inadequate temperature control can easily occur during transport, storage or even in consumer’s home. These findings have sparked new calls for a U.S. Food and Drug Administration recall of Zantac and related generic drugs and will likely fuel class action Zantac cancer lawsuits (ZANTAC) already underway.

 

CANCER LINK

    
In September 2019, the FDA warned consumers that medications containing ranitidine, including some common over-the-counter heartburn medications like Zantac, had been found to contain NMDA at low levels. NDMA is classified as a probable human carcinogen and has been linked to:

• Bladder, colon and rectal cancers;
• Esophageal cancer;
• Intestinal cancer;
• Kidney and liver cancers;
• Ovarian cancer;
• Pancreatic cancer;
• Stomach cancer; and
• Testicular and uterine cancers.

Further studies have suggested that ranitidine becomes chemically unstable when exposed to heat for prolonged periods of time – that the appearance of NMDA is not necessarily the result of external contamination, but the result of chemical deterioration.

HOW HOT IS TOO HOT? HOW LONG IS TOO LONG?

NMDA is a chemical compound already present in foods like smoked and grilled meats. The FDA has previously set safe consumption levels at 96 nanograms of NDMA per day. Valisure, an online pharmacy that conducts independent testing, has found levels in excess of 3,000,000 ng per ranitidine tablet.

Testing further found that NMDA levels exceeded the FDA’s daily 96 ng after just five days at 158 degrees Fahrenheit. After 12 days at the same temperature, the lab found 142 ng of NDMA.

The upshot is that medications deemed “safe” when tested at the point of manufacture may be dangerous after two weeks in a shipping container or days in a hot car. The temperatures are lower than previously understood and the time frame shorter.

NO FDA RECALLS, VOLUNTARY EFFORTS ONLY  

The FDA appears to have delegated enforcement of safe drug standards to the private sector. Sandoz, which makes a generic version of Zantac, recalled 14 lots of its product because of NDMA above levels deemed safe by the FDA. Other generic makers like Glaxo-Smith-Kline and Dr. Reddy’s Laboratories stopped shipping their ranitidine products but stopped short of implementing any recalls.

Appco Pharma, Northwind Pharmaceuticals, Glenmark and Mylan Pharmaceuticals have recalled ranitidine and similar drugs because of NDMA. CVS and Walgreens have taken Zantac and generic heartburn drugs off their shelves.

France, Canada, Switzerland, Germany, Austria, and other countries have also recalled all forms of ranitidine from their markets after detecting NDMA.

In its most recent announcement, the FDA has encouraged patients taking prescription ranitidine who wish to stop to speak to a health care professional.
 

CLASS ACTION ZANTAC CANCER LAWSUITS        

The opportunities to join a class action Zantac cancer lawsuit are increasingly plentiful. How to make the right choice of a law firm and what to expect of a lawsuit are somewhat less obvious.

You should, of course, do some consumer research about the reputation of any law firm you are considering. Giant awards and big settlements are important, but not the whole story. Look also for information about client responsiveness and geographical location. These kinds of lawsuits can take a long time, so your relationship with a law firm may extend for months or years.

Secondly, you can help your case along by assembling and organizing information. Your chances for success or failure will depend on three things:

• Information that you can show about your use of Zantac or other ranitidine drugs – how long, was it prescribed or over-the-counter, what was the dosage, what conditions did you use it for? Even if not prescribed by a doctor, was it recommended? Did your doctor monitor your use or symptoms?
• How were you harmed? Did you develop cancer of any kind? What kind of cancer? Assume that you will have to collect and organize a lot of medical records, from doctors, hospitals and other medical professionals. What is your prognosis?
• What leads you to believe that there is a link between your use of ranitidine and the harm that you suffered? This may be part of your medical records, but anything else you can add may be significant. Any link you can provide regarding storage of your medication and heat may be newly significant.

Your lawyer can be helpful with these issues, but you may be able to provide significant assistance. Federal regulators appear to have left consumers increasingly on their own, as far as drug safety is concerned, but that does not mean that you are entirely without resources and legal assistance.