Pfizer says that it’s voluntarily recalling some of its blood pressure drug products and two authorized cheaper generic versions of the drug because of elevated levels of a potentially cancer-causing impurity.
The pharmaceutical giant stated on March 21 that it’s recalling six lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets that are used to treat the symptoms of high blood pressure.
Pfizer stated that the tablets, which were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March, have been found to contain the presence of nitrosamines.
According to the 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, overexposure 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 stated that it hasn’t received any reports of adverse events related to the drug recall thus far and that it believes that 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. Patients currently taking the products should consult with their doctor about alternative treatment options,” the company stated.
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 has 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 because of high levels of a nitrosamine impurity (N-nitroso-quinapril).
The recall involved eight lots of Accuretic medication in 10/12.5-milligrams (mg), 20/12.5-mg, and 20/25-mg strengths, according to Health Canada.
However, the regulator noted that there was no immediate risk in continuing to “temporarily” take Pfizer’s recalled drug, as the potential risk of cancer is associated with long-term exposure (every day for 70 years).
Prior to that, Pfizer Canada stated that it was recalling 15 lots of another blood pressure drug, Inderal, because of the same nitrosamine impurity concerns.
That recall covers multiple batches of 60-mg, 80-mg, 120-mg, and 160-mg extended-release capsules, according to the Canadian health department.