Why did it take the agency six months to pull Zantac / ranitidine products after it had identified potential problems?
(May 11, 2020) The FDA recalled Zantac on April 1, 2020, along with other ranitidine medications that contain NDMA or N-Nitrosodimethylamine. The announcement came seven months after the agency warned the public – in Sept. 2019 – to consider taking over-the-counter (OTC) meds or other prescription treatments instead of Zantac and other ranitidine products.
The FDA recall last month came a full six months after Walgreens, Rite-Aide, Wal-Mart, and other retailers had already pulled ranitidine medications from their shelves.
What is Zantac / Ranitidine?
Zantac and ranitidine products are used for what many call heartburn. Drugs.com explains: “Ranitidine works by reducing the amount of acid your stomach produces. Zantac is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome.”
What took the FDA so long to recall ranitidine, which was linked then, and now, with an increased cancer risk? When the agency warned the public in September 2019, why didn’t it pull ranitidine products such as Zantac then? The FDA claimed at the time that it did not have enough evidence that ranitidine products were dangerous. Ok. But why did the agency choose to err on the side of drug company sales rather than on the side of consumer safety? This product was hardly indispensable to anybody. Nobody’s life depended on their taking it.
The agency said last month that it determined the impurity in some ranitidine products increases over time and when stored at higher than room temperatures. FDA said that may result in consumer exposure to unacceptable levels of NDMA. The market withdrawal request meant that ranitidine products would no longer be available for new or existing prescriptions or OTC use in the U.S.
FDA cannot assure Quality of Drugs
Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, tried to explain away the agency’s late action: “(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.”
Lost in her “explanation” is the fadt that the agency was forced to look more closely at ranitidine after an independent pharmacy did its own testing, did the job that most americans likely believe the FDA is paid to do: assure drug safety. The agency does nothing of the kind. It does no studies of its own. It simply relies on studies done by different drug makers, companies which obviously have vested interests in their own studies’ outcomes.
NDMA is well-known to be a probable human carcinogen. In summer 2019, the FDA became aware that independent laboratory testing by a pharmacy had found NDMA in ranitidine. The agency said that low levels of NDMA are commonly ingested in the diet, in foods, and in water. It says those low levels would not be expected to lead to increased cancer risk. However, sustained higher levels of exposure may increase the risk of cancer in humans.
The FDA then confirmed through testing and evaluation prompted by information from third-party laboratories that NDMA levels increase in ranitidine even under normal storage conditions. In addition, NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures it may be exposed to during distribution and handling. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was made, the greater the level of NDMA. FDA now acknowledges that these conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.
And so, finally, in May 2020, the FDA said it was sending letters to all ranitidine makers to request that they withdraw their products from market.
The FDA ended its ranitidine recall notice by trumpeting that the agency “continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.”
To which we can only smile grimly and say: “If only it were so.” And what does “pharmaceutical quality efforts across every product area” even mean?
* FDA late to pull Zantac