The Legal Examiner Affiliate Network The Legal Examiner The Legal Examiner The Legal Examiner search instagram avvo phone envelope checkmark mail-reply spinner error close The Legal Examiner The Legal Examiner The Legal Examiner

Another Blood Pressure Drug Recalled Due to Possible Cancer-Causing Risk

Heart disease is the world’s leading cause of death. There are 116 million Americans who suffer from hypertension, also called high blood pressure. About 40 percent of them rely on medication to treat it.  

Unfortunately, recent issues with several of these drugs are cause for concern. 

The FDA White Oak Campus, headquarters of the United States Food and Drug Administration

Over the last year, several manufacturers of high blood pressure medications have had to recall their products due to unacceptable levels of a nitrosamine called N-Nitroso-Quinapril. 

Nitrosamines, which are found in water and many foods such as grilled meats, dairy products and vegetables, are human carcinogens. They can be deadly when ingested in large amounts over an extended period of time. 

Recent Recalls

On Dec. 21, officials at Lupin Pharmaceuticals of Maryland issued a voluntary recall for four lots of its blood pressure drug Quinapril after determining that its levels of N-Nitroso-Quinapril were unacceptable for patients. 

The affected drugs were distributed in 90-count bottles from March 2021 through Sept. 2022, with expiration dates ranging from Dec. 2022 through March 2024. 

Lupin’s news came just weeks after another drugmaker, Aurobindo Pharma USA, issued a similar recall. On Oct. 24, officials of that company announced that two lots of Quinapril and Hydrochlorothiazide, dated back to May 2021, were tainted with N-Nitroso-Quinapril. 

In March 2022, Pharmaceutical giant Pfizer also withdrew some of its drug products due to the same nitrosamine. The company held a voluntary recall of Accuretic (quinapril HCl/hydrochlorothiazide) and two generics distributed by Greenstone, a subsidiary of Pfizer, since November 2019. 

Pfizer recalled another round of drugs the following month. This one involved five batches of Accupril, which is used not only to treat high blood pressure patients but also those with a history of heart failure. 

Increasing Number of Medications With Too Many Nitrosamines

While announcing these recalls involving nitrosamines, the Food and Drug Administration (FDA)  stresses that patients should continue taking their prescribed medicine while reaching out to their doctor for guidance. The agency has repeatedly reminded patients that everyone is regularly exposed to “some level of nitrosamines.” 

However, despite the very small chances of ingesting enough nitrosamines to cause cancer, the fact remains that the pharmaceutical industry’s recalls pertaining to their presence in medications have significantly increased in recent years. 

Here is a look at other recalls involving several nitrosamines.

The FDA stepped up its focus on nitrosamines in 2018 after toxins were discovered in Valsartan/Angiotensin II receptors, which treat heart failure and high blood pressure. Researchers discovered that a nitrosamine called N-Nitroso-N-methyl-4-aminobutyric acid developed when a solvent created a chemical reaction.

In 2020, five manufacturers were forced to recall Metformin, a drug used to help control high blood sugar in patients with type 2 diabetes, when the FDA found a nitrosamine called N-Nitrosodimethylamine in certain extended-release versions of the popular medication. 

In 2021, the makers of the anti-smoking aid Chantix issued a recall. Scientists reported that a chemical reaction involving its active ingredient, varenicline, would form a nitrosamine during manufacturing.

Zantac Lawsuits

While countless people have been affected by the many nitrosamine-based drug recalls in recent years, those associated with ranitidine, the main ingredient in over-the-counter heartburn medicine Zantac, could be the most far-reaching. 

Back in 2019, workers at Valisure, a pharmacy and research company, found N-nitrosodimethylamine in ranitidine, prompting a massive recall of Zantac products.

The FDA ordered manufacturers to withdraw the ulcer and stomach drug after determining that storing ranitidine products in areas exceeding room temperature can increase their levels of N-nitrosodimethylamine to “unacceptable” levels.  

The following year, Zantac launched a new version of its product, Zantac 360, which replaced ranitidine with the FDA-approved H2 blocker famotidine. Despite this, the 2020 recall has wreaked havoc on Zantac manufacturers. People across the country have filed Zantac lawsuits alleging that drug manufacturers did nothing to protect the consumer despite knowing the risks posed by the carcinogens. So far, more than 110,000 filed and unfiled claims have been registered.

How a Lawyer Can Help With Recalled Drug Injuries

If you are currently taking Quinapril or another drug that has been recalled due to nitrosamines, or if you have cancer and believe a recalled drug caused it, consider contacting an experienced product liability lawyer for guidance. You may be eligible to receive compensation for the harm caused by the medication. 

If you are using a recalled drug, consult your healthcare provider as soon as possible to decide whether to replace it with a different medication. Anyone experiencing an adverse reaction to a drug can file a report with the FDA’s MedWatch Adverse Event Reporting Program.