Company pulls drugs aimed at treating heart attacks and strokes over nitrosamine contamination
The drug company Pfizer announced Monday it was recalling several lots of its drug Accuretic along with two generic versions, citing unacceptably high levels of a substance that US regulators said could cause cancer. People who used the blood pressure drugs to reduce the risk of stroke and heart attacks were advised to find alternatives.
Several “tainted” lots of Accuretic and two authorized generic versions of the drug (quinapril HCl/hydrochlorothiazide) distributed by Greenstone were found to have levels of N-nitroso-quinapril above the Acceptable Daily Intake (ADI) set by US regulators, Pfizer said in a statement. The company provided lot numbers and other information to identify the bad lots of the drugs.
While everyone is exposed to some level of nitrosamines, these “impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” Pfizer noted.
The company did not specify what nitrosamine level was detected in the tainted lots, but said that the drug has “a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program,” as well as that they are “not aware of reports of adverse events that have been assessed to be related to this recall.”
“Pfizer believes the benefit/risk profile of the products remains positive based on currently available data,” the statement said. The recall is purely voluntary and is being conducted “with the knowledge” of the US Food and Drug Administration (FDA).
Accuretic and its generics are prescribed for high blood pressure, in order to reduce the risk of “cardiovascular events” such as strokes and myocardial infarctions, i.e. heart attacks.
Patients currently taking them should “consult with their doctor about alternative treatment options,” Pfizer said, while wholesalers and distributors with the listed lots should “stop use and distribution and quarantine the product immediately.”
The New York-based pharmaceutical behemoth is worth billions of dollars and makes a variety of drugs. Over the past two years, it has also emerged as the principal maker of mRNA-based Covid-19 vaccines.
