Pharmaceutical giant Pfizer has announced that it has recalled batches of its blood pressure drug products due to high levels of cancer-causing impurity.
In a statement Monday, Pfizer said that it is voluntarily recalling the products along with two authorized cheaper generic versions of the drug due to elevated levels of the impurity.
The Big Pharma company said it is recalling six lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets which are used to treat the symptoms of high blood pressure.
Pfizer said the tablets, which were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022, have been found to contain the presence of nitrosamine.
According to the U.S. Food and Drug Administration (FDA), Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables.
While everyone is exposed to some level of nitrosamines, over-exposure to the impurities for extended periods of time can lead to an increased risk of cancer.
Drugs that contain levels of nitrosamines that are above the acceptable daily intake limits are recommended by the FDA to be recalled.
Pfizer said it has so far not received any reports of adverse events related to the drug recall and believes the “benefit/risk profile of the products remains positive based on currently available data.”
“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said.
“Patients currently taking the products should consult with their doctor about alternative treatment options.”
Pfizer also noted that the products “have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program.”
However, it asked that wholesalers and distributors who have an existing inventory of the products in the recall stop using and distributing the products immediately.
Pfizer’s announcement regarding the recall comes after Pfizer Canada recalled all lots of Accuretic due to high levels of a nitrosamine impurity (N-nitroso-quinapril).
The recall involved eight lots of Accuretic medication in 10/12.5-mg, 20/12.5-mg, and 20/25-mg strengths, Health Canada said.
However, the regulator noted that there was no immediate risk in continuing to “temporarily” take Pfizer’s recalled drug since the potential risk of cancer is associated with long-term exposure (every day for 70 years).
Prior to that, Pfizer Canada said it was recalling 15 lots of another blood pressure drug, Inderal, due to the same nitrosamine impurity concerns.
That recall covers multiple batches of 60-mg, 80-mg, 120-mg, and 160-mg extended-release capsules, the Canadian health department said.