Zantac Contamination Concerns: Has Drug Been Recalled and Chances of a Class Action Lawsuit?

Zantac and ranitidine have made numerous headlines in recent weeks, after the Food and Drug Administration (FDA) decided to investigate possible contaminants in ranitidine products on September 13 and companies (like CVS) chose to voluntarily suspend the sale of the heartburn medication.

The crux of the matter is a naturally-occurring compound called N-nitrosodimethylamine (NDMA), found in low (but "unacceptable") levels in random samples of the drug tested.

NDMA is found in food, drink and the environment among other things, but rarely in levels that would cause for concern.

While there are currently class actions being considered against manufacturers of Angiotensin II receptor blockers (ARBs) after the FDA had to issue a number of recalls on products containing unacceptable levels of the contaminant, it is too early to predict the same will happen to producers of drugs like Zantac. That's what Katherine Van Tassel, a Visiting Professor of Law at Case Western Reserve University School of Law, told Newsweek.

At this point in the investigation, it does not appear there is sufficient evidence to show that over-the-counter and prescription ranitidine products containing the NDMA impurity could cause cancer, she explains.

This is a view shared by Michael D. Green, Professor of Law at Wake Forest University School of Law, who told Newsweek: "It's important to find out what the dose is."

"The dose makes the poison," he said. This means that as the dose goes up, so do any adverse health effects—provided there are any. But at this point, it looks like levels of the contaminant in these products are not much more that you'll find in cooked foods, says Green.

"The decision of the FDA to investigate the drug—and of companies like CVS, Walmart, Sandoz and Apotex Corp. to voluntarily recall the drugs—is the administration being very cautious," he continues.

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Packages of Zantac, a popular medication that decreases stomach acid production and prevents heartburn, sit on a shelf at a drugstore. The FDA is investigating the product after tests found small amounts of a probable carcinogen in versions of Zantac and other forms of ranitidine. Drew Angerer/Getty

It is not something people should get overwrought about, he adds. While he recommends seeking out an alternative, he says consumers shouldn't worry if they are currently taking the product or have done so in the past.

On a strictly theoretical note, to have a strong case to take a drug manufacturer to court, a consumer would have to prove by "a preponderance" of the evidence that their malady was caused by their use of a particular medication, says Van Tassel. That is commonly explained as requiring a finding that at least 51 percent of the evidence shown favors their story and outcome, she adds.

"Another way to think of the standard is to simply ask whether the plaintiff's proposition is more likely to be true than not true."

Impurities like NDMA turn up in medications sold in the US more often than most realize, says Van Tassel. She cites docusate sodium, a stool softener that was frequently prescribed to hospital patients to prevent constipation, as a good example. It was found to contain the bacterium Burkholderia cepacia and was recalled—but not before the contamination seriously injured some consumers.

As things stand, the FDA has not requested that manufacturers recall the product.

Levels of NDMA found in these products have not been confirmed, but in its latest update (published October 2), the FDA asked manufacturers of ranitidine to conduct their own laboratory testing to determine levels of NDMA in their products in accordance to FDA guidelines, which do not use elevated temperatures.

The FDA has said it will provide more information as it becomes available.

Zantac Contamination Concerns: Has Drug Been Recalled and Chances of a Class Action Lawsuit? | Health