Pfizer recalls drugs that could cause cancer – Reuters

Company withdraws drugs intended to treat heart attacks and strokes following nitrosamine contamination

Pharmaceutical company Pfizer said on Monday it was recalling several batches of its drug Accuretic as well as two generic versions, citing unacceptable levels of a substance that US regulators say could cause cancer. People who used blood pressure medication to reduce the risk of stroke and heart attack were urged to find alternatives.

Many “tainted” Batches 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, said Pfizer in a statement. The company provided lot numbers and other information to identify bad lots of drugs.

While everyone is exposed to some level of nitrosamines, these “impurities can increase cancer risk if people are exposed to them above acceptable levels for long periods of time,” Pfizer to note.

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The company did not specify what level of nitrosamine was detected in the contaminated batches, but said the drug has “a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program”, as they are “not aware of adverse event reports that have been assessed as being related to this recall. »

“Pfizer believes that the benefit/risk profile of the products remains positive based on currently available data,” the statement said. The recall is purely voluntary and is ongoing. “with knowledge” from the United States Food and Drug Administration (FDA).

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Accuretic and its generics are prescribed in arterial hypertension, 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 their doctor about alternative treatment options”, Pfizer said wholesalers and distributors with the listed lots should “Stop use and distribution and immediately quarantine the product. »

The New York-based pharmaceutical giant is worth billions of dollars and manufactures a variety of drugs. Over the past two years, it has also become the leading maker of mRNA-based Covid-19 vaccines.



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