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Zantac Manufacturer Has Halted Shipments Over Possible Carcinogenic Ingredient

In September, the FDA noticed a chemical called NDMA included in the heartburn medication Zantac along with its generic ranitidine counterparts. NDMA is a naturally occurring chemical found in smoked and cured foods, and the FDA has classified it as a “probable human carcinogen.” That means there’s a very good chance it can cause cancer over time, and it’s one of the main reasons why the FDA and health organizations recommend staying away from grilled and processed meats.

NDMA isn’t the active ingredient in Zantac, but the FDA discovered more NDMA in Zantac and generic ranitidine pills than the average amount found in food sources. The amount isn’t much higher, though, and so the FDA hasn’t issued a recall. However, the company behind Zantac, Novartis, has halted production for the time being.

How It Got There

Drug manufacturing is very precise, but it’s also very complicated. Chemists will start with a few chemicals and then run them through several processes like heating, cooling, vaporization, condensation, combination with other chemicals, and purification. The process creates a lot of byproducts the manufacturers will then reuse or throw out, but sometimes the purification process doesn’t get everything. In fact, many chemicals are hard to detect unless you know exactly what you’re looking for.

That’s most likely what happened in this case. The process to make ranitidine probably produces a little NDMA as well, and both ended up in the final product since the manufacturer didn’t know they had to look for it.

What The Response Means

NDMA isn’t an immediately dangerous chemical, at least not if you avoid eating too much of it. It can cause some long-term problems as a probable carcinogen, but people who only eat smoked or grilled foods occasionally don’t have much to worry about. The NDMA quantities found in Zantac and other ranitidine drugs is only slightly higher than the amounts in smoked foods, so you can say the same thing about them.

That’s why the FDA hasn’t issued a recall or warned people to stop using the drug. If you only need heartburn medication occasionally, Zantac should still be safe enough to use. However, if you take a prescription-strength heartburn drug or you use the over-the-counter version daily, it’s probably a good idea to switch to something else until the company can change or adjust its manufacturing process.

What The Legal Issues Are

The NDMA discovery probably won’t result in much legal action. The chemical doesn’t have an absolutely proven link to cancer, unlike things such as cigarette smoke and asbestos, plus it’s hard in general to link cancer to specific causes. Novartis has done the responsible thing by halting production as soon as the evidence came to light, and there’s a very good chance the company wasn’t aware that the drug contained NDMA until now.

The relatively mild response also means that the FDA doesn’t believe the NDMA presents much of a health risk to the public. However, the Zantac discovery is part of an ongoing FDA investigation into blood pressure medications, and other drugs have had much higher levels of NDMA that have led to recalls. Future testing may reveal more, but for now Zantac seems to be one of the less affected drugs in this investigation.

What the Zantac discovery highlights is that drug dangers can come from more than just the active ingredient. The manufacturing process is just as important as the end result, and if the process changes then so do the impurities that end up in the pills. If you take medication regularly, whether it’s over the counter or prescription, remember to keep an ear to the ground just in case.

Michael J. Babboni's wide-ranging legal career is based on the strong belief that everyone should be treated fairly and have access to effective legal help. Michael began putting his beliefs in action by helping the people of St. Petersburg Florida get what they are owed in civil trials fighting to protect families by making corporations pay, and honor their obligations.

Zantac Manufacturer Has Halted Shipments Over Possible Carcinogenic Ingredient

Goldman Babboni Fernandez
Murphy & Walsh

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