Zantac May Cause Cancer, FDA Admits

FDA announces two more antacid recalls due to cancer risk

Jan 10, 2020

Wired.com – Two more companies recalled their ranitidine drugs, generic forms of Zantac, over concerns they may contain a carcinogenic substance.

That burning feeling in your chest after you eat a heavy meal could be heartburn.

Or it could be worry over the drugs you’ve taken to treat that heartburn. Among the top medical stories of 2019 was the discovery of contaminants in common medicines, and ranitidine—best known as Zantac—took up a large share of those headlines.

A cancer-causing substance known as NDMA has been repeatedly found in one of the most popular antacid drugs in the United States.

The scary news continues in 2020. On Wednesday, the Food and Drug Administration announced voluntary recalls of prescription forms of ranitidine by two generic drug companies, Appco Pharma and Northwind Pharmaceuticals, bringing the total number of ranitidine recalls to 14 in the past five months.

The agency also reported that Mylan Pharmaceuticals recalled three lots of Nizatidine (Axid), a similar drug, again because of NDMA.

This week’s recalls are a new cause for alarm for the 15 million Americans who take ranitidine at prescription levels, and the millions more who regularly take lower-dose, over-the-counter versions.

More than 60 million Americans experience heartburn at least once a month. Zantac was once the best-selling drug in the world.

Bianca Ryan, the season 1 winner of America’s Got Talent, took to Twitter after the voluntary recalls this fall:

“I’m literally hyperventilating, like, I’ve been taking Zantac every single day for the last 10 years for my GERD,” she wrote, referring to gastroesophageal reflux disease, a frequent or more serious form of heartburn, which occurs when acid from the stomach flows up into the esophagus “So—what do I use now?! And they found what in it?!”  Read more. 

Commentary: U.S. Reliance on China for Generic Drugs Is a Security Threat

Sep 30, 2019

U.S. News & World Report – Last week, drugmaker Novartis issued a recall of generic versions of the popular heartburn medication Zantac.

The Food and Drug Administration recently announced that the drug’s active ingredient, ranitidine, had been contaminated with a carcinogen known as NDMA. On Monday, CVS pulled Zantac and its generics from its shelves; Walgreens had already stopped selling the drug earlier.

This recall will impact patients suffering from a variety of excess stomach acid conditions. But it’s the safety of the generic drug supply as a whole that should give all Americans heartburn.

Congress is currently focusing on a legislative effort to reduce the out-of-pocket costs of brand name prescription drugs. This is a worthy effort.

Yet it shouldn’t overlook the other pressing prescription drug problem: the safety risks posed by many generic drugs, which make up roughly 90% of the drugs Americans take.

Ranitidine is just the latest in a string of generic prescription drug safety contaminations in recent years. Last year, the FDA announced that the same carcinogen contaminated the popular blood-pressure medication valsartan, spurring a massive recall that affected tens of millions of patients.

The biggest prescription drug crisis of recent years was the 2008 contamination of heparin, a widely used blood thinner. The FDA estimates that 149 Americans died and many hundreds more were seriously injured as a result.

What’s responsible for the repeated drug safety lapses? The offshoring of the American drug supply to China and, to a lesser extent, India during the past couple of decades.

Lax safety standards and FDA oversight at plants in those two countries have allowed these drugs — and likely countless more we don’t know about — to become contaminated and endanger patients. China and India now manufacture about 80% of the drugs consumed in the U.S.

This figure understates China’s dominance because many of the active ingredients in the Indian manufactured drugs come from China. The U.S. doesn’t even manufacture vital drugs like antibiotics anymore, with the last penicillin factory closing in 2004.

In 2017, FDA inspectors investigated a plant at China’s Huahai Pharmaceuticals, which manufactured contaminated valsartan, and found rust, deteriorating equipment, ignored consumer complaints, testing anomalies and potential contamination. Two other Chinese plants were cited by the FDA last year for inadequate cleaning and maintenance procedures, unlocked and improper recording formulas, and inadequate testing, among other violations.

FDA inspectors are unable or unwilling to provide appropriate oversight of Chinese manufacturing.

In contrast to the robust testing required for approval for new prescription drugs, the FDA only requires that generic manufacturers prove that patients will absorb drugs at the same rate as the brand-name medications they copy. Read more. 

Should you be afraid of foreign-made drugs?

Oct 21, 2019

BY DR. MARC SIEGEL, OPINION

The Hill – Fear-driven phone calls about a common stomach medicine being contaminated with a cancer-causing chemical flooded my office on Friday, as the drug company mega-producer Sanofi added to the public alarm by recalling its popular product, Zantac-OTC.

This product is manufactured in the United Kingdom and Australia, whereas generic versions of the drug (ranitidine) recently recalled by Glaxo-Smith-Kline, Teva and others were made in India. This issue raises questions about drugs that are made overseas.

Walgreens, Walmart and CVS have removed the supposedly tainted drug from their shelves.

Nevertheless, my patients and friends understandably have had many questions, such as:

What is Zantac?

Both it and its generic equivalent, ranitidine, are histamine H2 blockers, which prevent the production of excess stomach acid, thereby being useful to treat reflux, gastritis and ulcers, among other related conditions. There are many alternatives, but millions rely on this drug.

What is the cancer-causing agent involved in this case, and should we worry about it?

The contaminant is a nitrosamine known as NDMA (N-Nitrosodimethylamine), and it has been shown to cause several kinds of cancer in mice, including uterine and bladder cancer.

Last year there was a scare about a common and useful blood pressure drug, Valsartan (much of it produced in China and India) containing NDMA.

A study published in Occupational and Environmental Medicine found that rubber workers exposed to NDMA had an increase in cancers of the throat and esophagus.

At the same time, a study over five years with regular use of Valsartan found no increase in cancer.

Nevertheless, Valsartan and several related blood-pressure drugs were withdrawn from the market, and the prescribing options for doctors has dwindled … Read more. 

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