Nearly four decades after it was approved, the FDA has ordered that heartburn drug Zantac and its generics be removed from the market, saying they have been exposing consumers to the risk of cancer.
The move comes six months after an independent lab warned the FDA of a potential carcinogen in ranitidine drugs and nearly three months after another lab told the FDA its tests determined levels of NDMA could increase if the drug is stored above room temperature.
The FDA at first equivocated about those findings, but said today that new tests by its scientists had confirmed them, leading the agency to withdraw all current versions of the ranitidine-based drug in the U.S.
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“We didn't observe unacceptable levels of NDMA in many of the samples that we tested. 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," Janet Woodcock, FDA director of the Center for Drug Evaluation and Research, said in a statement. "The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern."
In September 2019, online pharmacy and testing lab Valisure filed a citizen petition after tipping off regulators to the existence of a the potentially cancer-causing impurity in Zantac and other heartburn medicines. It is the same impurity that led to a global recall of blood pressure medicines.
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New Haven, Connecticut-based Valisure said the FDA should recall Sanofi’s Zantac and all other ranitidine products “to protect the American public from further exposure to the potentially carcinogenic properties of Ranitidine,” according to the petition, which was posted to a federal website Wednesday.
Then, in early January, another lab, Emery Pharma, filed its own citizen petition informing the FDA that its testing determined the level of the suspected carcinogen NDMA can increase if the drug is exposed to high heat, even after it has been packaged.
"Our preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer," the petition says.
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In a statement today, Valisure CEO David Light said, "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,"
Light went on to say that the labs findings also suggest that the unstable ranitidine molecule is prone to forming the probable human carcinogen NDMA in a variety of conditions.
"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 said. "We continue to investigate this clinical question with researchers at Memorial Sloan Kettering Cancer Center and look forward to publishing data soon."
Much of the ranitidine is already off the market; drugmakers responded to the news, and their own testing found elevated levels of the impurity.
NDMA and several other similar impurities were first discovered several years ago in “sartan” drugs taken for high blood pressure. The agency has been testing other drugs that might be susceptible to its creation as well.
EDITOR'S NOTE: The story was updated to reflect that Zantac was first approved in 1983.