Readers Write: Zantac and Lisinopril, what’s happening?

The Island Now

These are older drugs whose names many of you who are reading this article will recognize. The FDA has initiated recalls of generic Lisinopril and Zantac. The recalls from the FDA are both voluntary and mandatory for different drug manufacturers and the FDA does publish a list of these companies but most of us rely on the pharmacy that supplies our prescriptions to us for giving us products that are acceptable under the FDA guidelines.

What is a voluntary recall as opposed to a mandatory recall? A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration. The recall is a voluntary action that takes because manufacturers and distributors carry out their responsibility to protect the public health and wellbeing from products that present a risk of injury or gross deception.

However, there is sometimes confusion surrounding a “voluntary recall”. The term may create the impression that the problem is less serious, and that the company has simply decided to recall products as quality control measures. Some customers even confuse the term “voluntary” with “optional”, assuming that they can safely make their own decisions about whether or not to use the product. Voluntary recalls should be taken just as seriously as a mandatory recall. I called the FDA and was told that the current recalls of prescription drugs over an impurity known as NDMA have both voluntary and mandatory in their listings on their websites. NDMA is an environmental contaminant found in water and foods including meats, dairy products, and vegetables.

There are different classification by FDA recalls when issued by the FDA from Class 1 to Class III, 1 being a situation when there is a reasonable probability that the use of the products will cause serious adverse health consequences or death to the Class III in which use of the product of exposure to it is not likely to cause adverse health consequences.

The offending agent in this current recall of so many older drugs used to treat high blood pressure and certain gastrointestinal illness is called NDMA for short. It is currently classified as a  probable human carcinogen, at low levels.

In September 2019, the FDA learned that some ranitidine medicines, including some products sold under the brand name Zantac, contained NDMA. This was the beginning of the recall that has caused many patients to be put on different medications for their gastrointestinal problems that were being treated with both OTC and prescription drugs

In October 2019, the FDA observed that a third party laboratory was using higher temperatures in its test to look for NDMA. The NDMA was being generated by the added heat but the higher temperatures were recommended for using certain equipment in valsartan and other drugs. The FDA recommended using another method for its testing for NDMA.

In November 2019,  the FDA stated that their tests have found levels of NDMA in ranitidine and nizatidine that are similars4 to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.

Teva pharmaceutical Industries voluntarily recalled some of its blood pressure medicines in the U.S. due to an impurity in the drug that could cause cancer. The impurity detected is in an active pharmaceutical ingredient in the drug that was manufactured by Mylan in India. The impurity, NDMA, has been classified as a possible human carcinogen.

The FDA advises patients taking Amlodipine/Valsaretan or combinations of the two drugs to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment.

Everyone seems to agree on the seriousness of consuming too much NDMA, whether by the foods we eat or the pills we take. The blood pressure pill recall was again how much or how little it takes to cause serious health issues.

How serious is this problem of NDMA?

It seems to be very unclear how serious or dangerous this situation is. Pharmacists can recommend OTC medications for their stomach issues while the facts get sorted out. Drugs that can be used until that happens are famotidine, cimetidine, esomeprazole or omeprazole./ You should check with your own physician to see which of the above he/she would prefer for your particular problem.

The World Health Organization has reported several case-control studies, in humans, and none of them can be used to derive a quantitative risk of cancer.The results are supportive of the assumption that NDMA consumption is positively associated with either gastric or colorectal cancer. However, none of the studies focused on drinking water as the route of exposure, instead, they used estimates of total dietary intake of NDMA.

Again, the FDA advises all patients taking the above drugs should continue taking their medications and to contact their pharmacist or physician on alternative treatments.

Bertram Drachtman
Great Neck

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