In March, 2022, Pfizer voluntarily recalled its blood pressure medication, Accuretic, in addition to two generic drugs used to treat hypertension. Pfizer’s action was motivated by the discovery of nitrosamines in its blood pressure medications. On April 25, 2022, another Pfizer blood pressure drug known as Accupril was recalled due to elevated levels of the contaminant. Nitrosamines, which are found in the air, water, and certain foods, may increase the risk of cancer when exposure reaches certain levels.
Impurities Detected in Several Pfizer Medications
All lots of Accuretic (quinapril hydrochloride and hydrochlorothiazide) have been recalled in 10/12.5 mg, 20/12.5 mg and 20/25 mg strengths. Accurectic is used to treat high blood pressure. Pfizer’s recall comes weeks after the drug was recalled in Canada for nitrosamine contamination. Health Canada has been monitoring the presence of nitrosamine in affected medications since 2018. At that time, companies were required to provide assessments of their manufacturing procedures to identify potential contaminants.
Pfizer has additionally recalled Accupril, also known as Quinapril HCL, in 10 mg, 20 mg and 40 mg tablets in batches distributed from December 2019 to April 2022. In 2021, Pfizer faced similar challenges with the distribution of its anti-smoking drug, Chantix. Sales of Chantix were discontinued when NDMA was detected in the drug.
Pfizer has stated that it is unaware of any adverse events related to Accuretic. It also claimed that the drug’s benefits – lowering blood pressure and reducing the risks of strokes- outweighed its risks for most users.
Dangers of Long-Term Exposure to Nitrosamine
Most people come into contact with nitrosamine through exposure to water and air pollution, and consumption of foods such as cured meats and dairy. At low levels, nitrosamine does not pose a heightened risk of cancer. Ingesting a drug that contains nitrosamine at or below the acceptable level on a daily basis for 70 years is not projected to cause higher rates of cancer. However, nitrosamine has been found to be potentially dangerous at higher levels at prolonged rates of exposure. The International Agency for Research on Cancer classifies NDMA as a group 2A carcinogen which means that it is “probably carcinogenic to humans.” Because specific nitrosamines have been linked to cancer, the entire class of chemicals has been labeled as carcinogenic after long-term exposure.
Wave of Recalls following Discovery of NDMA in Ranitidine
In 2018, the Food and Drug Administration (FDA) released warnings about several medications that contain higher than acceptable levels of NDMA. The FDA notice came after Valisure, a pharmaceutical company that tests drugs for contamination, announced the presence of nitrosamine in ranitidine, the active ingredient in the popular heartburn medication Zantac. Valisure requested that the FDA expand testing after detecting the probable carcinogen. Plaintiffs filed a federal lawsuit in California claiming that drug manufacturers Sanofi, GlaxoSmithKline, and Boehringer Ingerlheim misled consumers regarding the risks of generic and branded Zantac. A separate lawsuit in Colorado against Pfizer also alleged that the manufacturer did not fully disclose the dangers of Zantac to consumers. Lawsuits against these manufacturers are seeking compensation for various cancers, including bladder, stomach, esophageal, liver, and pancreatic cancer caused by prolonged exposure to NDMA.