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April 1, 2020 Health Care

FDA yanks heartburn drug Zantac after safety concerns raised by NH's Valisure

PHOTO | File image by Liese Klein Valisure staff members (l-r): Nico Zenzola, research associate; David Preli, senior research associate; Kaury Kucera, chief scientific officer; Amber Jessop, data scientist; Jessica Williston, administrative assistant, and Paul Barry, pharmacist.
By Natalie Missakian

Ten months after New Haven online pharmacy Valisure first warned the U.S. Food & Drug Administration about a cancer risk from a popular heartburn drug, the agency has pulled Zantac and its generic versions from the market.

As a result of the order, ranitidine products including Zantac will no longer be available over-the-counter or by prescription in the U.S., the agency said Wednesday. Ranitidine is the generic name for Zantac. 

The decision comes after an FDA investigation found levels of a potential carcinogen in ranitidine products can increase over time and when stored above room temperature. 

The agency said the instability could result in consumers being exposed to “unacceptable” levels of NDMA, or N-Nitrosodimethylamine, low levels of which are commonly ingested in foods like grilled or cured meats.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation & Research, in a statement Wednesday. “However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”

Elm City-based Valisure, a startup pharmacy that runs quality checks on all the medication it sells, first alerted the FDA last June to high levels of the chemical it discovered in routine testing of the drug at its lab in Science Park.

The company filed a citizens petition last fall urging the FDA to recall the heartburn medication, which is routinely prescribed to infants and was once the world’s best-selling drug. 

At the time, the FDA said it didn’t have enough scientific evidence to tell people to stop taking Zantac, but suggested people switch to other heartburn medications while it investigated the risk. 

Most pharmacy chains responded by voluntarily pulling the drug from their shelves last fall, and many drug makers stopped selling it. 

On Wednesday, the FDA said new testing and evaluation prompted by information from “third-party laboratories” confirmed that NDMA levels increase in the drug even under normal storage conditions, and increase significantly in samples stored at higher temperatures. 

The findings echo what Valisure said its own testing methods found last year: That the drug was unstable and prone to forming NDMA under a variety of conditions, including high temperatures. 

"We're very glad that Valisure's laboratory testing has had such an impact and we strongly support and applaud FDA's decision to remove all ranitidine products from the market, a move that has already been done in dozens of countries around the world,” Valisure CEO David Light said in a written statement to New Haven Biz Wednesday afternoon.

“We remain concerned about not just storage and transportation but also the potential degradation of ranitidine in the human body which may produce even higher levels of NDMA,” Light added.  “We continue to investigate this clinical question with researchers at Memorial Sloan Kettering Cancer Center and look forward to publishing data soon." 

Contact Natalie Missakian at news@newhavenbiz.com

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