Accuretic Drug recall

Accuretic Recall News: Pfizer Recalls Blood Pressure Meds Due to Cancer Risk

March 27, 2022
Author: Daniel Gala

On March 21, pharmaceutical giant Pfizer announced the voluntary recall of three blood pressure medications due to the presence of a carcinogenic compound in amounts that may exceed recommended exposure levels.   

The recalled drugs include Pfizer’s brand name Accuretic (quinapril HCI/hydrochlorothiazide) as well as two generic drugs authorized by Pfizer and distributed by Greenstone, quinapril and hydrochlorothiazide and quinapril HCI/hydrochlorothiazide. In all, Pfizer announced the recall of six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCI/hydrochlorothiazide tablets.   

“Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product,” Pfizer said in its recall announcement.   

The carcinogenic compound detected in the recalled drugs is N-nitroso-quinapril, which belongs to a class of carcinogens knowns as nitrosamines. While nitrosamines are present in small amounts in certain foods such as cured or grilled meats, they have long been known to cause cancer when exposure exceeds certain levels.   

Originally approved by the US Food and Drug Administration (FDA) in 1999 for the treatment of hypertension (high blood pressure), Accuretic is available in tablet form and is taken orally. Over its decades of use, Accuretic has been associated with a range of adverse reactions, including fetal toxicity, a risk for which the drug has garnered a black box warning, the FDA’s highest level of warning.   

The cause of the nitrosamine impurities in Accuretic and its generic cousins do not appear to be known at this time, but they are hardly the first drugs on the US market to suffer from nitrosamine impurities in recent years.   

A Troubling Trend of Nitrosamine Impurities   

The Accuretic recall comes on the heels of several other major drug recalls that also were prompted by the discovery of nitrosamines in pharmaceuticals sold in the US. Beginning in July 2018, the FDA announced a series of drug recalls involving a class of blood-pressure medications known as angiotensin II receptor blockers (ARBs)—including valsartan, irbesartan, and losartan—after they were found to be contaminated with nitrosamines. After an investigation, the FDA determined that the nitrosamine contamination was due to faulty manufacturing processes at overseas plants in China and India.   

Subsequently, in September 2019, the FDA issued a statement announcing that the nitrosamine NDMA had been detected in the blockbuster heartburn drug Zantac and generic forms of ranitidine. Unlike with the ARBs recall, the nitrosamines in Zantac and generic ranitidine later were determined to be due not to contamination but to the chemical properties of the drug itself, which can transform into NDMA when digested in the human stomach or stored for long periods in high heat and humidity. In April 2020, the FDA formally requested the removal of all ranitidine products from the US market.   

Further, in July 2021, Pfizer voluntarily recalled nine lots of its smoking cessation drug Chantix (varenicline) due to the presence of the nitrosamine N-nitroso-varenicline.   

All of these drugs are now the subject of mass tort litigation that cumulatively contains multiple thousands of cases, and it is highly likely that the discovery of nitrosamines in Accuretic will prompt a similar flurry of lawsuits.     

Sources:   

Pfizer. (21 March 2022). Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Qanapril HCI/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCI/Hydrochlorothiazide Tablets Due to N-Nitroso-Quinapril Content. Company Announcement   

United States Food and Drug Administration (FDA). (Last updated 13 November 2019). FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). Drug Safety and Availability   

United States Food and Drug Administration (FDA). (13 September 2019). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. FDA Statement   

United States Food and Drug Administration. (1 April 2020). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. FDA News Release   

United States Food and Drug Administration (FDA). (2 July 2021). FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix). Drug Safety and Availability