US pharmaceutical giant Pfizer is voluntarily recalling five batches of its Accupril blood pressure tablets after finding elevated levels of a potential cancer-causing agent in the medicine.
The company said it was not aware of any reports of adverse events related to the recalled batches, which were distributed in the United States and Puerto Rico from December 2019 to April 2022.
Pfizer Canada also recalled all lots of three doses of Accupril last week after finding the same impurity to be above acceptable levels.
Pfizer said there was no immediate risk to patients taking this medication, in which the agent, a nitrosamine, was found.
In its statement Pfizer said:
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. 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.”
“Accupril is indicated for the treatment of hypertension, to lower blood pressure. Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years.”
It added: “To date, Pfizer is 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.”
“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 or health care provider about alternative treatment options for them.”