OP-ED: Patients Question Medication’s Safety After Another Drug is Tested for Carcinogen NDMA

BY AILEEN MACK

A wave of drug recalls linked to probable carcinogen N-nitrosodimethylamine (NDMA) have patients across the United States concerned about the safety of their medications. On December 4th, the U.S Food and Drug Administration announced that they would begin tests on type 2 diabetes drug metformin to see if the medication contains threatening levels of NDMA and plans to announce a recall if necessary. Until the FDA releases the results of these initial tests, doctors currently recommend patients continue taking their medication.

NDMA contamination is a recent trend in drug recalls across the country. Most notably, NDMA was found in the popular heartburn medication, Zantac, and its generic form, ranitidine. The contamination of ranitidine-based medications like Zantac was initially discovered in June 2019 by a small online pharmacy, Valisure. Described as a next-gen pharmacy, Valisure performs routine tests on every batch of medication they receive from manufacturers before prescribing the medication to patients. Valisure’s tests also discovered the potential for NDMA to be produced in the body of patients who took Zantac when ranitidine in the medication interacted with chemicals inside the patient’s stomach. Retailers like Walmart and CVS removed Zantac from store shelves after these findings were announced.

The recall came as a surprise to many consumers who took Zantac daily to treat heartburn. However, other medications, like high blood pressure medication Valsartan, were recalled over similar NDMA contamination concerns back in July 2018. A study conducted in Canada showed that visits to the emergency department for hypertension increased by 55% after the recall, which may suggest that some patients are unable to find safe and effective replacements for recalled drugs in time to treat their conditions.

Following the valsartan recall, class action lawsuits were filed against the manufacturers of the drug alleging the contaminated medication caused a variety of cancers. Sanfoi, Zantac’s manufacturer, is also facing a similar legal response to the NDMA contamination with two major class action suits filed in both New Jersey and California.

Drug contamination and subsequent recalls have unfortunately become a semi-regular occurrence in the lives of American consumers in recent years. Some experts believe it is our healthcare system’s reliance on forgeign manufacturers that results in drug contaminations and threatens the health and safety of consumers. However, many pharmaceutical companies argue that the dangers of drug contamination are overblown and do not pose a real danger to patients.

When asked about Zantac’s recall and the risk it posed to patients, Valisure CEO David Light said, “There’s no acceptable cancer risk for a drug like this.” Light’s opinion echoes the thoughts of many consumers who are beginning to wonder why the drugs that are supposed to save their lives might actually be risking them.

It is unclear what the public response to the latest metformin tests will be, but doctors are currently recommending patients replace Zantac with the following medications:

• Pepcid (famotidine)
• Tagamet (cimetidine)
• Nexium (esomeprazole)
• Prevacid (lansoprazole)
• Prilosec (omeprazole)

Aileen Mack is a consumer advocate who is currently focused on researching drug recalls, specifically recalls that feature carcinogen NDMA. She is passionate about informing consumers about drug safety and keeping consumers in the loop concerning pharmaceutical industry dealings.