What Is Zantac
Zantac, a drug named ranitidine hydrochloride, is a histamine-2 receptor blocker, widely used in the treatment of Zollinger-Ellison Syndrome and GERD, or any other condition where your stomach produces a lot of acids. It also helps treat and prevent ulcers in the stomach and duodenum, the first part of the small intestine. Zantac can also be taken as an over-the-counter treatment for heartburn.
Zantac was first developed and patented by the European pharmaceutical company, GlaxoSmithKline. It was made available in both forms; prescription and over-the-counter form. The drug was a huge success when it hit the market due to its efficiency. So much so, that it is the first drug to make $1 billion in the US.
In 2019, the FDA warned users of Zantac of potential risks that were reported by individual laboratories. They warned the public about the presence of certain carcinogens in batches of ranitidine. Walmart, Walgreens, Rite Aid, and CVS decided to remove ranitidine from their shelves following this warning. This was not an official recall, but rather a decision made by those companies on their own. Meanwhile, the FDA continued to perform tests and started an investigation into the Zantac (ranitidine) and carcinogen claims. During this investigation, they recommended Zantac users discontinue using the drug and instead use alternative over-the-counter medications.
NDMA And Cancer
The carcinogen in question is NDMA, N-Nitrosodimethylamine. Since it was recognized as a carcinogen in the 1970s, it has been found to cause cancer in every animal that it was ever tested on. It is produced as the by-product of certain industrial reactions and is a very common contaminant. So common that it is found in very low doses in our food and water. The CDC has continuously warned about NDMA even in low doses. After some evaluation and tests, the FDA determined that the daily intake of 96 nanograms of NDMA is not harmful to the human body. It is important to not exceed that daily limit.
In September 2019, Valisure, an online pharmacy, informed the FDA of ranitidine batches being contaminated with NDMA. As a result of the testing done by Valisure, they found NDMA levels of 2,511,469 ng in OTC Zantac. This is an extremely high dosage and it needed to be investigated immediately.
On initial testing, the FDA did not find the levels of NDMA to be as high as claimed by Valisure. They believed that Valisure performed the tests at higher levels than those in the body, and that caused high levels of ranitidine. It was soon realized that Valisure claims had merit, which is why they chose to warn users about potential risks while they continued to do further tests and evaluations. However, they did not recall the drug.
Dr. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research released the following statement, “The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured, The FDA will continue its efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
Upon further investigation, the FDA became aware of the risks of NDMA and found high levels of it in Zantac batches. Initially, FDA associated higher levels of NDMA in ranitidine with testing being done in higher temperatures. However, they soon realized that these levels could also be possible at normal, room temperature.
In December 2019, Congresswoman Rosa L. DeLauro wrote a letter to FDA urging them to take down Zantac from the shelves, and ban it due to the cancer risk. She also wrote in her letter, ‘“Valisure’s data, in combination with four decades of scientific research, strongly suggest that ranitidine is a fundamentally unstable molecule and all products containing this drug have a risk of cancer”.
They held a press release where the following statement was made, “New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.”
FDA officially recalled the drug in April 2020, although had recommended discontinuing its use due to potential risks earlier in September 2019. However, certain pharmaceutical companies had already recalled this drug on their own, before this announcement by the FDA.
This Zantac recall came soon after the Valsartan recall, in early 2019. Valsartan, an angiotensin receptor blocker drug, had also been found to be contaminated by NDMA.
The FDA also sent out letters to all pharmaceutical companies, like Novartis-Sandoz, Apotex, Pfizer, GlaxoSmithKline, Sanofi, Boehringer, that manufacture ranitidine hydrochloride to recall their products. They also urged people who had Zantac at their houses to not use the drug and to discard it. All users of Zantac were asked to talk to their doctors and use an alternative medication. Some of the alternative medications recommended by the FDA are famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
Canada and France also recalled ranitidine because ‘current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer’. Furthermore, 22 other countries joined in the recall of ranitidine hydrochloride and banned its use, until further studies and proper investigations can be carried out.
What Damage Can NDMA Cause To The Body?
NDMA, an environmental toxin, can cause cancers if consumed in high amounts, like those found to be associated with Zantac use. It can affect the lungs, gastrointestinal tract, breast, cervix, thyroid, ovaries, prostate, and testicles, with the ability to cause cancer in all these organs.
Multiple plaintiffs have come forward with complaints against Zantac use after Valisure, the online pharmacy, first alerted the FDA of unsafe amounts of NDMA contaminant in the drug. The number of lawsuits continued to increase, especially after the FDA announced the Zantac recall. Valisure claimed that not only was ranitidine contaminated by NDMA, but it could also break down in the stomach and form NDMA.
Claims made by individuals are only accepted by lawyers if they follow the three criteria; Zantac uses, cancer diagnosis, and connection between the diagnosis and drug use.
A plaintiff from Kentucky claims that he took Zantac, 150mg every day from 2014, till 2017. In January 2018, he was diagnosed with bladder cancer. The plaintiff now believes that his bladder cancer was the result of carcinogens found in Zantac.
Another plaintiff from Indiana claims that she regularly took ranitidine from the 1980s to early 2020. In 2018, she was diagnosed with uterine cancer, for which she underwent a hysterectomy. She now believes her cancer was the result of her ranitidine use and feels that the pharmaceutical company failed to notify the public of the risks of ranitidine use. Her official complaint reads as follows:
Despite the undeniable scientific evidence linking ranitidine to the production of high levels of NDMA, “Defendants did not disclose this link to consumers on Zantac’s label or through any other means”. She claims that if she had known of the dangers of Zantac use, she would not have used the drug, and could have potentially avoided developing cancer.
As of February 2020, the United States Judicial Panel on Multidistrict Litigation amalgamated all lawsuits in the Southern District of Florida under U.S. District Judge Robin Rosenberg.
The main claim of Zantac lawsuits is against the name brand manufacturer, Sanofi. They allege that Sanofi was aware of the risks of ranitidine and the levels of NDMA in the packaging but failed to inform the general public, causing severe health consequences in Zantac users.
Sanofi Pharmaceuticals faced its first Zantac lawsuit in September of 2019. The plaintiff, in this case, was a male, Florida resident who had been taking Zantac since 2009. He was diagnosed with breast cancer, a rare diagnosis in men, in 2013. The plaintiff alleges that his cancer was the result of Zantac use, and Sanofi Pharmaceuticals were well aware of the risks and chose not to disclose them.
The plaintiff also alleges that even if Sanofi was initially unaware of the NDMA levels and Zantac association with cancer, they had plenty of time to study the very obvious connection between increased cancer incidence in Zantac users. Since they chose not to, this Florida resident wants to be compensated for his pain and suffering.
Another plaintiff from Colorado filed a lawsuit against Sanofi US Services Inc., Chattem, Inc., Boehringer Ingelheim, Pfizer, and GlaxoSmithKline in October 2019. He claims that he started using Zantac in 1996, and was taking it 4 times a week. The plaintiff was then diagnosed with bladder cancer in 2018, which he alleges was due to Zantac. He wrote in his official complaint, “This was not done by accident or through some justifiable negligence. Rather, Defendants knew that it could turn a profit by convincing consumers that Zantac was harmless to humans, and that full disclosure of the true risks of Zantac would limit the number of money Defendants would make selling Zantac,”
In October 2019, Sanofi recalled its Zantac products in the US, UK, and Canada.
One of the attorneys, R. Brent Wisner, fighting the case in court against Zantac called the drug the cause for the epidemic of cancer that we are facing today.