Zantac Heartburn Medication Linked to Cancer

Zantac (ranitidine hydrochloride) is being investigated after 150 Zantac tablets were found to contain a carcinogenic chemical up to 3,000 times greater than the FDA’s daily intake limit. The chemical found in the popular heartburn drug is N-nitrosodimethylamine (“NDMA”). Numerous studies have shown a link between the NDMA in Zantac and cancer. Evidence increasingly also indicates that Sanofi and Boehringer Ingelheim, the big pharma companies that make Zantac (ranitidine hydrochloride), concealed the Zantac cancer link.

Zantac Suspension, Recall and the FDA

While the FDA has not gone so far as to recall the heartburn medication, it has found “unacceptable levels” of N-nitrosodimethylamine (NDMA) in samples of drugs containing ranitidine in its testing, according to Reuters (Oct 2, 2019).

Two weeks before the above FDA announcement, U.S. and European regulators said they are reviewing the safety of ranitidine. Walmart said it is halting sales of Equate and Member's Mark brands of ranitidine. CVS suspended sales of Zantac and CVS Health store brand ranitidine on Sept. 28. (A suspension is not a recall: customers have not been told to stop using them; rather, they can return the medication at a later date for a refund.)

After learning of the FDA investigation, Apotex Corp. is recalling Ranitidine Tablets 75mg and 150mg at the retail level where it was distributed nationwide to Warehousing Chains. (Apotex, a Canadian pharmaceutical corporation, is the largest producer of generic drugs in Canada.)

The FDA on October 2 asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send to the agency samples of their products for testing. The FDA will then assess oral ranitidine medicines and says it is currently testing samples of other heartburn treatments such as proton-pump inhibitors as part of the investigation.

Zantac and Valisure

The agency is, however, investigating Zantac cancer risks after receiving the first alarm on September 9, 2019 from online pharmacy Valisure, which requested the FDA to recall and suspend sales of ranitidine from the US market. The FDA "has established a permissible daily intake limit for the probable human carcinogen, NDMA, of 96 ng. Valisure has detected NDMA in excess of 3,000,000 ng per tablet when analyzing ranitidine products, likely due to an inherent instability of the ranitidine molecule,” wrote Valisure Chief Scientific Officers. Valisure further requests in the letter that the FDA:
 “promulgate regulations requiring robust independent chemical testing and verification of medications. In the interim, while these regulations are pending, FDA should issue formal guidance recommending such testing and verification. This is necessary in order to serve public health and help protect Americans from adulterated and poor quality drug products, an issue of growing concern. Grounds for this request are also rooted in strong support from the medical community, as evidenced by a recent resolution from the American College of Cardiology (“ACC”), calling for the American Medical Association to advocate for legislation requiring independent testing and verification of the chemical content of batches of pharmaceuticals.”

The FDA checked the over-the-counter drug using a low-heat method of testing, and said it found much lower levels of the NDMA than was discovered with a higher temperature test used by Valisure.  The agency further said that Valisure’s method, which Valisure had used for testing ARBs (some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers), was not suitable for ranitidine.

“An analysis Valisure conducted in conditions similar to the human stomach generated over 300,000 nanograms of NDMA, significantly above acceptable levels set by the FDA, David Light, Valisure’s chief executive told Reuters, and this shows that even if the pills are not contaminated, the drug is likely to form the impurity in patients’ stomachs after it is ingested.

Valisure indicates that a copy of the Zantac recall petition has also been sent to the World Health Organization (WHO) and International Agency for Research on Cancer (IARC), as a nomination for ranitidine to be classified as a human carcinogen.

What is Zantac ?

Zantac (ranitidine hydrochloride) is an over-the-counter (OTC) medication that has been used for decades by millions of people worldwide to help treat heartburn. The FDA approved Glaxo Holdings in 1983 to market Zanatac as a short-term treatment of a common form of ulcers. By 1988 it became the world’s best selling drug, topping $1 billion in annual sales. By 1997 Glaxo’s patent for ranitidine expired in the U.S. and generic alternatives were launched. Sanofi SA currently sells Zantac in the U.S.

It is also used for acid reflux, gastroesophageal reflux disease (GERD), sour stomach, Barrett’s esophagus, gastric and duodenal ulcers, and other issues. Ranitidine Hydrochloride Tablet is an OTC oral product indicated for the relief of heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

What is NDMA?

The carcinogenic chemical present in Zantac is known as N-nitrosodimethylamine (“NDMA”). It is produced as a by-product of several industrial processes and found at very low levels in certain foods, especially those cooked, smoked, or cured. NDMA is toxic to the liver and other organs and is a probable human carcinogen.

NDMA is the same contaminant found recently in many brands of blood pressure and heart failure medicines, leading to recalls. For instance, European and American regulators recalled blood pressure drug valsartan made by China’s Zhejiang Huahai Pharmaceuticals after finding NDMA in samples of the drug.

Regulators have since found the carcinogenic impurities in a wide number of the drugs in the same class, called angiotensin II receptor blockers, or ARBs. The potentially cancer-causing impurities may have been introduced by recent changes in the manufacturing process for the drugs, and recalls of some ARBS led to shortages of the medications, including valsartan -- the generic of Novartis’ Diovan. Novartis in September stopped global distribution of its ranitidine drugs. And Canada has requested drugmakers to stop selling and distributing ranitidine.

Did Manufacturers Hide the Cancer Link?

The EPA considers NDMA a probable carcinogen, stating that animal studies have found that prolonged exposure led to tumors in the liver, lungs, and elsewhere.  And a study published in Carcinogenisis (2016) show that people who take ranitidine have high levels of NDMA in their urine, suggesting that it is created in the body.

Mounting evidence also allegedly shows that Sanofi and Boehringer Ingelheim, the big pharma companies that make Zantac (ranitidine hydrochloride), concealed the Zantac cancer link. This deception occurred when companies made unprecedented profits from Zantac, according to attorneys.

Zantac Lawsuits

Attorneys are now investigating Zantac cancer claims and a number of Zantac lawsuits are being filed against Sanofi and Boehringer Ingelheim for their reckless disregard for human health and putting profit over harm.

Valisure tested eight other popular alternatives to Zantac, including Tagamet, Pepcid, Prilosec, Nexium, Prevacid, Protonix, AcipHex and Dexilant. No detectable levels of NDMA were found in those medications.
 

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Last updated on Oct-31-19