Zantac heartburn medication was the world’s best-selling drug in 2019, topping $1 billion in sales. After nearly 34 years on the market, new Zantac cancer concerns arose in September 2019, when the FDA found the drug contained a probable human carcinogen.
The root cause of the contamination is still unclear, prompting recalls of Sanofi’s Zantac and its generic equivalents until we have more conclusive research. In the meantime, the FDA advised prescription patients to consult their doctors and OTC patients to consider alternative drugs approved for their condition such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec – which all tested negative for the carcinogen.
FDA Issues Zantac Recall
On September 13, 2019, the FDA detected an unacceptable level of nitrosodimethylamine (NDMA) in random test samples. The FDA’s “acceptable” limit is 96 nanograms per day, or 35,040 annually. According to recent testing, the exposure level of patients taking 150mg of Zantac daily would be 889,000,000 ng a year.
Similar NDMA impurities have also been found in several blood pressure medications like losartan and have been under FDA investigation for more than a year.
In response to the finding, French drugmaker Sanofi voluntarily recalled Zantac OTC from the shelves of retailers like Rite Aid, Walmart, Walgreens, and CVS.
Although the chains suspended sales, the drugmaker isn’t halting shipments to the U.S. “We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards,” Sanofi said in a statement.
Recall Expands to Include Generic Ranitidine
In addition to the Zantac recalls, half a dozen generic ranitidine producers pulled their products from pharmacy shelves, including:
- Novartis-owned Sandoz
- Denton-owned Northwind Pharma
- Mylan-owned Solara Active Pharma Sciences Ltd
- Appco Pharma
According to news reports, the companies have issued “cautionary distribution stops” on their stomach acid and ulcer medications “until further clarification” is reached on what’s causing the high levels of NDMA. The companies say they are “not aware of any adverse events,” but urge consumers to immediately discontinue use and discard unused medicine.
What Is the Zantac Cancer Link?
Right now, there is much uncertainty within the scientific community regarding what might be causing the unacceptable levels of NDMA. The FDA notes that NDMA is “a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”
Both the Environmental Protection Agency and International Agency for Research on Cancer have classified NDMA as a “probable human carcinogen,” and the World Health Organization states that NDMA consumption is “positively associated with either gastric or colorectal cancer.”
Animal studies have found sufficient evidence that oral administration of NDMA can cause kidney, bladder, liver, and lung cancers. A 2004 study of gastric ulcer patients (many of which were managing the condition with Zantac) found this cohort had a higher risk of bladder cancer.
There are several theories on what might be causing the Zantac cancer link:
- A private lab believes the problem stems from the drug’s composition and how it interacts once inside the body.
- Some animal researchers believe the body’s metabolization of NDMA damages DNA and initiates mutations into the DNA sequence.
- Most recently, Emery Pharma — a California-based private laboratory – found that ranitidine is a temperature-sensitive molecule. The more it is heated, the more NDMA is generated. They found many cases where the drugs were sitting in packaging well after analysis from manufacturers. As little as five days in the heat could send NDMA levels skyrocketing. The scientists advised that the drug be shipped in temperature-controlled vehicles and include a warning about the potential risk. On January 2, 2020, Emery Pharma filed a citizen petition with the FDA.
Research Labs and Individual Plaintiffs Filing Zantac Cancer Lawsuits
Plaintiffs filed product liability and class action lawsuits in nine federal court districts within a few weeks of the recall. As word about Zantac cancer spreads, we can expect many more lawsuits nationwide.
Among those who have filed so far:
- “Joseph G” – Breast Cancer – The odds of a man developing breast cancer are very low, with just 2,670 men diagnosed in 2019. However, a Miami man who took Zantac for frequent heartburn and acid reflux from 2009-2018 was diagnosed with breast cancer in 2013, for which he underwent a mastectomy and multiple rounds of chemotherapy.
- “William M” – Prostate Cancer – A New Jersey man was diagnosed with prostate cancer after taking Zantac three times a week for more than five years.
- “Gary H” – Colon Cancer – A California man who took 300mg of Zantac daily from 2000 through 2008 developed colon cancer in May 2008. According to the lawsuit, the dangers of NDMA have been known since 1979.
- “Mark B” – Bladder Cancer – A Colorado man began using prescription Zantac in 1996 and continued to use the OTC version four times a week through 2019. In 2018, he was diagnosed with bladder cancer and only recently heard about the NDMA contamination.
- “Nancy L” – Breast Cancer – A single mother and nanny from Florida was diagnosed with breast cancer in 2012, despite having no family history of the disease. She had, however, used Zantac for acid reflux since the age of 15. She told reporters, “This is not about money. This is about saving people. If I can save one, everything is gonna be worth it for me. It doesn’t matter what I’ve been through. That’s not a problem. I just don’t want other people to go through what I went through.”
What to Do If You Believe You May Have Zantac Cancer
The research is still unfolding, but it is not too early to contact a lawyer if you have taken Zantac and received a cancer diagnosis. It costs nothing to consult with an attorney at Showard Law Firm about pursuing a claim. You only pay the standard legal fee IF and WHEN your attorney obtains compensation on your behalf through settlement or a trial jury award.
Here’s all you need to do:
- Confirm that you took Zantac. Obviously, you don’t need every receipt. However, contacting your pharmacy and requesting a copy of your prescription records (if they exist) can help establish that you have used Zantac. Proving OTC use is more difficult without receipts, but we can use statements from loved ones, doctor’s notes, medical records, and journal entries to substantiate your routine use of the drug.
- Confirm the dates of use. Variables like the dosage, the number of times per week, and the number of years you took the drug will matter in your claim for compensation. The strongest cases will be those of patients who used Zantac regularly and long-term.
- Confirm your diagnosis. In order to pursue an individual claim, you must show that you suffered a specific injury. This can be done by obtaining medical records from your doctor’s office. We are still waiting for the medical research to catch up, but we have researchers and scientists available to provide compelling testimony.
- Confirm the latency period. Current science indicates at least one year between the time you first took Zantac and the development of cancer.
- Consult a lawyer. Showard Law Firm’s Zantac lawyers can help you explore the possibility of litigation to pursue compensation for your medical expenses, lost wages, pain and suffering, and other related expenses. We have experience taking on big pharma and winning!
Keep in mind each state has a statute of limitations – a deadline for filing legal action. The clock started ticking in September 2019, when the FDA first initiated its recall, at which point Zantac users “should have reasonably known of the cancer correlation.” The deadline varies from state to state. So, do not delay; contact us as soon as possible.
Additional resources:
- USA Today, https://www.usatoday.com/story/money/2019/10/01/generic-zantac-pulled-store-shelves-what-we-know-so-far/3827869002/
- British Medical Journal, https://www.bmj.com/content/362/bmj.k3851
- National Institute of Health, https://www.ncbi.nlm.nih.gov/pubmed/14973090