Zantac Recall: the Issues

Overview of the Zantac Recall - Zantac manufacturers Sanofi (a French multinational pharmaceutical company headquartered in Paris, and the world’s fifth-largest pharmaceutical beginning in 2013) and Boehringer Ingelheim (another of the world’s largest pharmaceutical companies, and the largest private pharmaceutical), have had to deal with a recall of Zantac, an OTC product to prevent and relieve heartburn.

In September 2019, a public statement was made by the FDA alerting consumers that some ranitidine medications, including Zantac, could contain NDMA at “low levels.” At that point, Sanofi and Boehringer Ingelheim were asked to engage in testing to determine how serious the issue really was. Evaluations were made of the active ingredient as well as the finished drug products, however, due to inconsistencies in preliminary test results, Sanofi decided a voluntary recall was required.

Since different suppliers source the active ingredients in Sanofi’s ranitidine products outside the U.S. and Canada, the situation was even more challenging. Sanofi pledged transparency, vowing to continue communicating any testing results with health authorities, as well as to work with health authorities to be able to make better decisions, based on available evidence and data.  Zantac was first approved by the FDA in 1983, after receiving approval in 31 other countries. By 1988, Zantac had become the world’s best-selling drug—and one of the very first drugs to top $1 billion in yearly sales.

By 1997, the U.S. patent for ranitidine expired, leading to generic alternatives of the drug being launched across the globe. Pfizer received FDA approval for an over-the-counter version of Zantac, then, through a variety of transactions, the drug was held by Johnson & Johnson, Then Boehringer Ingelheim, and then Sanofi. The first we heard of NDMA contamination in a drug was in 2018 when European and American regulators recalled the blood pressure drug Valsartan after discovering the impurity in a number of blood pressure medications.

NDMA was also found in some drug samples of ranitidine, and by September 2019, both United States and European regulators were reviewing the safety of ranitidine. By September 28, 2019, CVS drugstores had pulled Zantac and its own generic ranitidine products from the shelves. Walmart, Walgreens, and Rite Aid soon followed suit.

By October 2019, the FDA said it had discovered unacceptable levels of N-nitrosodimethylamine (NDMA) in ranitidine, and GlaxoSmithKline, the original manufacturer of the drug, recalled all prescription-only Zantac medications. Eventually, after Teva Pharmaceutical recalled some batches of ranitidine, Sanofi recalled over-the-counter Zantac in the U.S. and Canada. The U.S. FDA waited until very recently to issue an FDA Zantac recall and a ranitidine recall FDA, due to the rising allegations of FDA Zantac cancer.  

Did the FDA Request that Sanofi/Boehringer Ingelheim Recall Zantac? As of April 1, 2020, the FDA announced that it would request all manufacturers of ranitidine withdraw over-the-counter and prescription drugs that contained ranitidine, due to the levels of NDMA found in some samples of the drug. NDMA is known as a probable human carcinogen. The FDA believes the contamination in the drug can become worse over time or when the drug is stored at room temperature, exposing those who take drugs containing ranitidine to “unacceptable levels of this impurity.” While this is the “official” Zantac recall of the drug ranitidine, Sanofi voluntarily recalled ranitidine in the U.S. and Canada months earlier. This heartburn medicine recall has serious implications for hundreds of thousands of those across the globe.

How Does Ranitidine Work? Ranitidine is an H2 blocker that works to reduce the symptoms of heartburn via binding to proteins in the stomach, known as histamine H2 receptors. After you eat, the body releases gastrin, a hormone that aids in digestion by increasing the movement of the stomach and prompting the release of the chemical histamine. Histamine then binds to H2 receptors, releasing gastric acids to help break down the food.  If you have heartburn, the muscle (esophageal sphincter) that needs to loosen, allowing food and drink to get to your stomach, relaxes when it should not, resulting in acid reflux. Ranitidine and other H2 blockers decrease gastric acid, meaning there is less to flow back into your esophagus, causing symptoms of heartburn.

What is NDMA? NDMA is a yellow liquid with no distinct odor. It is produced in the United States for use only as a research chemical. At one time, NDMA was used to make rocket fuel, however, this particular use was discontinued after high levels of NDMA were found in soil, water, and air samples collected near a rocket fuel manufacturing plant. This leads many people to wonder how NDMA could have possibly gotten into our medications. In some cases, NDMA can unintentionally be formed during the manufacturing process from a reaction with other chemicals known as alkylamines.

NDMA breaks down in sunlight in a matter of minutes. The primary sources of human exposure for NDMA include tobacco smoke, chewing tobacco, eating a diet high in cured meats, beer, cheese, fish, cosmetics, shampoos, cleansers, detergents, and pesticides. NDMA can also form in the stomach of humans while digesting alkylamine-containing foods. Occupational exposure for NDMA can occur in the fish processing industries, foundries, tanneries, pesticide manufacturing plants, and dye manufacturing plants. NDMA is harmful to the liver and can also cause lung cancer and liver cancer.

Specifically, Which Zantac Drugs are Involved? All prescription Zantac drugs, as well as all over-the-counter Zantac drugs, are involved in the recall. Further, all generic drugs containing ranitidine are a part of the recall as well. Consumers are advised to stop taking Zantac or ranitidine tablets or liquids they currently have and to dispose of them properly. Consider using other approved OTC products for the treatment of heartburn, such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec). If you were only taking ranitidine occasionally, you could switch to another H2 blocker, such as famotidine or cimetidine, which have shown no NDMA contamination.

What are the Dangers Associated with Zantac? A large study published in Carcinogenesis in 2019 found that intake of NDMA was associated with an increase in the development of pancreatic cancer, in addition to being harmful to the liver and potentially causing lung and liver cancers. Other types of cancer which could be caused by NDMA include stomach cancer, cancer in the small and large intestines, colorectal cancer, esophageal cancer, bladder cancer, prostate cancer, leukemia, Non-Hodgkin’s lymphoma, and multiple myeloma.  

If you or a loved one have taken NDMA-contaminated ranitidine and are experiencing unintentional weight loss, poor appetite, a change in bowel habits, nausea or vomiting, chronic, severe back pain, fatigue, dizziness, weakness, yellowing of the skin or eyes, dark or bloody urine, or itchy skin, you should seek medical attention immediately. Ranitidine cancer can be extremely serious; your Zantac cancer risk may be dependent on how long you took ranitidine or Zantac, and how high your dosage of the drug was. The NDMA in Zantac can lead to serious cancers, therefore, you should speak to your doctor regarding any concerns.

Are There Current Zantac Lawsuits? There are current Zantac lawsuits that argue ranitidine is unstable, also alleging that as far back as 1981, drugmakers were aware of studies pointing to the formation of NDMA in Zantac when ranitidine made contact with nitrite in the body. Florida resident, Joseph L. Galimidi, was one of the first to file an individual Zantac lawsuit in the United States against Sanofi last September. Galimidi had been taking Zantac since 2009, developing breast cancer in 2013—a cancer that is very rare among men. Mark Allan Blake, a Colorado resident, filed a Zantac lawsuit against Sanofi on October 21, 2019.

Blake began taking prescription Zantac in 1996, switching to OTC Zantac, which he took at least four times per week. Doctors diagnosed Blake with bladder cancer in 2018. There are a number of proposed Zantac class-action lawsuits filed on behalf of those in New Jersey, California, Florida, Connecticut, and Massachusetts. Neither Sanofi nor Boehringer disclosed to consumers that the drug had a critical defect, in that it could produce high quantities of NDMA in the body, a chemical described by the WHO as clearly carcinogenic.

What About Anticipated Lawsuits? To qualify for a Zantac cancer lawsuit or settlement, you will be required to show you took Zantac or generic ranitidine. If you took prescription Zantac, this becomes much easier. Proving over-the-counter use of Zantac or other ranitidine products is more involved, but can be accomplished through receipts, or other types of corroborating evidence. Next, you must show an injury directly related to Zantac or generic ranitidine, such as a diagnosis of cancer. Finally, your Zantac attorney will show that your ranitidine use and cancer diagnosis are related. Taking higher doses of Zantac would obviously be more helpful in proving such a relationship.

If you took Zantac or ranitidine regularly for at least one year, and at least a year has passed between the time you first took Zantac and the time you were diagnosed with cancer, you could qualify for a Zantac cancer lawsuit. It is likely there will be Zantac class action lawsuits and ranitidine class action lawsuits, or you could qualify for a “regular” lawsuit against Zantac or a ranitidine lawsuit. An experienced Zantac attorney can help you sort out the details of your exposure and subsequent diagnosis.

How a Zantac Lawyer Can Help - If you have exhibited symptoms of one of the cancers found to be caused by Zantac or ranitidine, or you have already received a cancer diagnosis, and you believe your specific cancer is the result of taking Zantac or ranitidine, you might want to consider speaking to a highly experienced Zantac attorney regarding a Zantac cancer lawsuit. You could benefit from speaking to a highly skilled Zantac lawyer from the Houston firm of Sullo & Sullo.

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