Earlier this year I wrote a blog post that discussed the recent revelation that Zantac might cause cancer. Scientists found a link between N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance, and ranitidine, the key ingredient in Zantac.

A few things have changed since that blog post, such as the U.S. Food and Drug Administration (FDA) asking all manufacturers to immediately recall drugs containing ranitidine from the market.

Why Did the FDA Ask for a Recall?

The FDA based this decision on its findings that the levels of NDMA could increase over time when stored at higher than room temperatures. The FDA’s new testing found that “NDMA levels increase in ranitidine even under normal storage conditions.” The FDA also discovered that “the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.”

There is debate on how the NDMA makes its way into medications such as Zantac. The FDA sometimes seems to take the approach that the NDMA is an impurity found in medications with ranitidine. However, the major theory is that as ranitidine breaks down in the human body, it creates very high levels of NDMA.

One study from 2016 supports this theory. Ten adults each took just 150mg of ranitidine (the recommended dose is 150mg, twice a day) with scientists analyzing their urine for 24 hours. They found that NDMA levels in the urine increased by a factor of 400.

Despite this massive increase, it’s still a conservative number. That’s because the human body will metabolize some of the NDMA before it can be removed through urine.

Regardless of how the NDMA finds its way into the human body, it’s clear that NDMA is something that people should avoid, especially for its increased cancer risks.

How Does NDMA Cause Cancer in Humans?

The World Health Organization explains that NDMA causes cancer when a particular enzyme converts NDMA into a methyldiazonium ion. This ion then leads to DNA damage, which can turn healthy cells into cancerous cells.

The U.S. Environmental Protection Agency (EPA) classifies NDMA as a “B2 (probable human) carcinogen.” This is based on studies that have found cancer in the liver, kidney and lungs of several different types of laboratory animals. Other studies have potentially linked NDMA to other cancers, such as pancreatic cancer, stomach cancer and bladder cancer.

Currently, there is the fear that Zantac and other medications containing ranitidine can lead to many types of cancers, including:

• Small intestine cancer
• Colorectal cancer
• Esophageal cancer
• Throat cancer
• Nasal cancer
• Thyroid cancer
• Liver cancer
• Brain cancer
• Colorectal cancer
• Kidney cancer
• Breast cancer
• Lung cancer
• Ovarian cancer
• Prostate cancer
• Testicular cancer
• Uterine cancer
• Multiple myeloma
• Non-Hodgkin lymphoma

It’s thought that this cancer risk is cumulative, which means the more someone takes ranitidine, the higher that person’s risk of developing cancer. The problem is that until last year, the widespread view by medical professionals was that ranitidine was an extremely safe drug. This means potentially millions of people were taking ranitidine non-stop for years and even decades.

Currently, more research is underway to better understand the links between NDMA and cancer, including exactly what types of cancers are the result of medications containing ranitidine.

If you have taken Zantac or any other drug with ranitidine for an extended period of time and have been diagnosed with any of the above cancers, it’s possible that your cancer was the result of you taking ranitidine.

As scientists complete their research and learn more, I’ll be sure to provide additional updates and information. In the meantime, feel free to call me at (919) 830-5602 if you have any questions, and if you took Zantac for an extended period and later developed cancer, call me to discuss your potential case against the pharmaceutical company Sanofi.

Many of us suffer from heartburn, and one of the most popular ways to treat it is by taking Zantac. Until recently, Zantac was considered a very safe medication and was available without a prescription.

Given how well it worked, along with its affordable price and the perception of safety, hundreds of thousands of people, if not millions, took Zantac. In the fall of last year, the US Food and Drug Administration (FDA) reported that this popular drug might contain N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance.

The past few months have resulted in mass voluntary recalls and a rush of FDA updates and reports about the possible dangers of taking Zantac and what it means for consumers. This blog post will attempt to summarize what’s going on and briefly discuss what happens next.

What Is Zantac?

Zantac is the brand name of a popular H2 histamine receptor antagonist called ranitidine. In plain English, Zantac is an antacid. It works by reducing the amount of stomach acid your body produces. Zantac is most commonly used to treat heartburn, ulcers and acid reflux.

What Is NDMA?

Before you ask, no, Zantac won’t get you high. Though the initials might seem similar, Zantac does not contain the active ingredient found in ecstasy. Ecstasy is 3,4-methyl​enedioxy​methamphetamine or MDMA. The possible carcinogen in Zantac is NDMA, not MDMA. Confusion is understandable given how an “N” not only looks like an “M,” but it sounds that way, too.

The FDA considers NDMA a “probable carcinogen” as it has caused cancer in laboratory animals. NDMA, in very small doses, is possibly not harmful as it’s often found in cured and grilled meats. But with enough exposure, NDMA may cause cancer in humans, such as in the bladder and stomach. NDMA can also be harmful to your liver.

How Much NDMA Is in Zantac?

One of the first publicized instances of NDMA causing cancer was the Citizen Petition sent by Valisure to the FDA on September 9, 2019. In this petition, Valisure explained that in its testing, it found alarming levels of NDMA in ranitidine.

Per the FDA, humans can acceptably consume up to 96 nanograms (ng) of NDMA per day. Valisure tested various types of over-the-counter 150 mg ranitidine medications found at stores like Walmart, Walgreens and CVS.

Valisure discovered that the amount of NDMA found in each 150mg dose ranged from 2.2 to 3.2 million ng. So by taking just one 150mg pill each day, a person was potentially consuming about 30,000 times the amount of NDMA the FDA says is acceptable.

Even when using modified testing methods that should better simulate the human body, Valisure found that each 150mg pill had between 23,600 and 304,500 ng of NDMA. This still vastly exceeds the FDA’s recommendation.

Things get complicated when you look at the FDA’s ranitidine testing results, which found far lower levels than Valisure did. The levels, while elevated, did not alarm the FDA enough to stop the sale of ranitidine.

What’s the FDA Doing About Zantac?

The FDA hasn’t done much besides issue Statements, Press Releases and Updates. However, they did complete their own testing of ranitidine and have asked ranitidine manufacturers to test for NDMA before their products hit store shelves. The following is a recent timeline of events:

September 13, 2019: the FDA publishes a Statement that announces it had become aware of possible problems with ranitidine. The FDA mentions that concerned consumers may ask for a different prescription or take an alternative over-the-counter antacid.

September 24, 2019: the FDA publishes a Press Release announcing the voluntary recall of prescription ranitidine capsules distributed by Sandoz, Inc.

September 26, 2019: the FDA alerts consumers and medical professionals that generic over-the-counter ranitidine made by Apotex Corp was being voluntarily recalled.

October 2, 2019: the FDA discusses more effective methods of ranitidine testing. Specifically, lower temperature testing methods should be used to avoid artificially raising NDMA levels.

October 23, 2019: the FDA further discusses NDMA testing procedures.

October 28, 2019: FDA announces more voluntary recalls.

November 1, 2019: the FDA publishes its ranitidine testing results for NDMA in an Update and issues a Statement. The overall conclusion is that NDMA levels were somewhat higher than what the FDA recommends, but not high enough to require all sales of the drug to stop. In fact, the FDA states that:

“FDA has determined that the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

November 8, 2019: the FDA alerts the public about a voluntary recall for ranitidine medications manufactured by Aurobindo Pharma USA.

November 22, 2019: the FDA mentions more voluntary recalls for ranitidine medications.

December 4, 2019: the FDA asks manufacturers to test for ranitidine before shipping to retailers.

December 18, 2019: the FDA announces a voluntary recall for ranitidine medications manufactured by Glenmark Pharmaceutical Inc.

January 8, 2020: the FDA announces that Appco Pharma LLC and Northwind Pharmaceuticals (for tablets manufactured by Glenmark Pharmaceutical Inc.) were issuing voluntary recalls of ranitidine.

For a complete list of FDA recall announcements involving ranitidine, please go to the FDA’s Recalls, Market Withdrawals, & Safety Alerts page.

Zantac Lawsuits Emerge

Given how popular Zantac has been and how long it’s been on the market in the US, we’re probably going to see a large wave of litigation against various ranitidine pharmaceutical companies. The lawsuits have already begun. A few of them include:

• Coggins v. Sanofi Case No. 3:19-cv-20060
• Rodriguez v. Sanofi, Case No. 1:19-cv-09527-AT
• Garza v. Sanofi, Case No. 5:19-cv-05772-NC
• Melillo v. Sanofi, Case No. 1:19-cv-06376

What’s important to note is that these lawsuits do not focus on cancer or other personal injuries due to the NDMA. These lawsuits were filed in late 2019 after news broke about the NDMA risks. Therefore, they are mostly suing on the basis of consumer fraud, breach of expressed and implied warranties and other unfair competition laws.

It’s only a matter of time before the personal injury class action lawsuits begin. One reason why they haven’t arrived yet is because they’re far more involved legal cases.

In most of the current cases in litigation now, plaintiffs are basically saying, “the defendant deceived me by not telling me of the health risks in taking ranitidine.” This is a lot easier to prove than saying, “ranitidine caused my cancer.”

Cancer is a complicated disease. Plaintiffs must figure out how much ranitidine was needed to cause cancer. This isn’t to say it’ll be impossible to prove ranitidine caused injuries in people, but it’ll take time to build a case.

What Does the Future Hold for Zantac?

These are still very new developments, so it’ll take some time to create a personal injury lawsuit against the makers and distributors of ranitidine. But there is huge potential for massive litigation. For instance, from 2007 to 2017, ranitidine was prescribed about 15 million times . . . per year . . . in just the US. And this doesn’t even count over-the-counter sales.

As more lawsuits get filed, it’s possible we can expect them to be placed into a multi-district litigation, or MDL. This will hopefully allow for more efficient litigation and maybe even a possible settlement that avoids decades of time in the courts.

Right now, it’s probably best to avoid taking anything containing ranitidine without at least talking to your doctor first. And as I get more information, I’ll post the updates in this blog. If you want to discuss Zantac, call me: (919) 830-5602.

Millions of Americans have stomach issues, many of which are related to heart burn and acid reflux. Thankfully, there are several medicines available over-the-counter and by prescription that prevent and relieve these discomforts. Some drugs that help with these stomach issues are called proton pump inhibitors.

A proton pump inhibitor (PPI) is a medicine that reduces stomach acid. People take PPIs for heart burn, acid reflux, stomach ulcers, and other related conditions. While many PPIs are available by prescription only, some are becoming more readily accessible over-the-counter; you may have seen or heard of Prilosec, Prilosec OTC, Prevacid, or Nexium. These are all well-known PPIs.

PPIs work by preventing stomach acid from being produced – they stop heart burn, indigestion, and acid reflux before it begins. Many people take them first thing in the morning or take them before meals.

While proton pump inhibitors help with heart burn, reflux, ulcers, and other conditions, they are causing other issues such as kidney disease, kidney injury, kidney failure, and interstitial nephritis (a type of kidney infection). Which begs the question – is preventing the occasional heart burn worth the risk of kidney failure? Or worse?

PPIs have been on the market since the 1980s and have been tolerated well by a majority of the population. In fact, some 15 million Americans take, or have taken, PPIs. Generally, these drugs cause few issues for the patient and cause minor side effects. For instance, Prilosec OTC states that its side effects are “mild” and are commonly headache and diarrhea. Prevacid’s side effects are listed as headache, nausea, diarrhea, constipation, and stomach pain.

However, long-term use of PPIs has caused some patients to experience more severe side effects. Recently PPIs have been associated with a risk of chronic kidney disease, also called renal disease. PPIs and their manufacturers do not warn against or provide information about this risk. Now there are lawsuits against PPIs such as Prilosec, Prevacid, Nexium, and their manufacturers due to these side effects, primarily involving injury or damage to the kidneys.

Lawsuits are being filed all over the country against pharmaceutical manufacturers like AstraZeneca, Proctor & Gamble, Takeda, and Pfizer. These law suits are being filed on behalf of patients who have ingested PPIs and later experienced various kidney injuries. For example, companies such as AstraZeneca are being sued because they failed to warn patients and doctors about the risk of kidney injury and instead continued to advertise PPIs as safe. A multi-district litigation site for PPIs has been designated in the federal court of New Jersey (MDL 2789), and injured people from all over the country are permitted to start a lawsuit in that court.

Proton pump inhibitors may reduce heartburn, prevent acid reflux, and help with stomach ulcers; but they may also cause kidney disease, kidney failure, and other issues. If you have taken a PPI and have experienced kidney problems – call me. Don’t let a medicine that was designed to cure stomach issues cause additional, more serious injuries.