Last April, Zantac, the world’s best-selling drug at one time, was recalled by the FDA. (Technically, the FDA requested the recall, but that’s splitting hairs.) Zantac wasn’t the best-selling antacid drug in the world, it was the leading pharmaceutical profit maker, generating over $1 billion in sales back in the late 1980s for former patent holder, GlaxoSmithKline.
Metformin is the most-prescribed blood-glucose lowering drug, and is often the first oral prescription that people newly diagnosed with type 2 diabetes take. According to DrugWatch.com, over 553 million prescriptions for Metformin were written from 2000-2015.
In November 2019, the FDA announced that some batches of extended release Metformin were found to contain a carcinogenic chemical compound called NDMA. Since then, several Metformin manufacturers issued voluntary recalls over concerns that NDMA may cause cancer.
And in 2018, Valsartan, one of the leading medications for high blood pressure (it’s also used for congestive heart failure) was also recalled because of NDMA contamination.
Where Does NDMA Come From?
NDMA is an impurity that’s classified as a probable human carcinogen. The chemical compound contaminates drugs due to the manufacturing process. High temperatures during the shipping/transportation of the finished product can also cause the presence of NDMA. So, too, can time itself. The longer a drug sits on the shelf, the higher levels of the impurity it may have.
But of these three popular drugs, Zantac is unique because it’s the drug’s main active ingredient—ranitidine—that leads to NDMA impurity. Rather than the manufacturing process serving as catalyst for NDMA contamination, with Zantac, it’s the breakdown of ranitidine that produces the carcinogen.
According to New York Injury Law News, it was the online pharmacy, Valisure, that first became aware of NDMA contamination in Zantac, back in June 2019. Valisure reported the impurity to the FDA, stating that randitinde itself was unstable and could break down to form NDMA.
New York Injury Law News says that Valisure told the FDA via a citizen’s petition that the ranitidine molecule contains both a nitrite and a dimethylamine (‘DMA’) group, which are well known to combine to form NDMA.
NDMA has been linked to several types of cancers. Because of the sheer volume of people who took Zantac—the histamine-2 (H2)-blocking antacid was available, both prescription and over-the-counter—over the years, legal experts are expecting a massive number of Zantac lawsuits. Already, dozens of claims have been filed, and, in February of 2020, were lumped together in a multi-district litigation.