Pfizer recalls blood pressure drug due to potential carcinogen
pharmafile | March 22, 2022 | News story | Manufacturing and Production |
Pfizer is voluntarily recalling certain hypertension medications due to the potential presence of impurities. The affected products have been distributed across the US, and also in Puerto Rico.
The company has recalled certain lots of Accuretic (quinapril HCl/hydrochlorothiazide), alongside two generics that were distributed by Greenstone: quinapril and hydrochlorothiazide.
Reasons for the recall include that it had a nitrosamine N-nitroso-quinapril presence higher than the Acceptable Daily Intake (ADI) levels, according to the company.
Nitrosamines are compounds that can increase people’s cancer risk if they are exposed to increased levels over a prolonged period of time, the FDA explained. We are actually exposed to these compounds daily, and they can be found in low levels in food, water, and even meat and dairy products. They can also form in drugs during the manufacturing process.
“(B)ut a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” noted the FDA.
“Pfizer believes the benefit/risk profile of the products remains positive based on currently available data,” the company said. “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 has reiterated that those who are using prescription medications which have potential nitrosamine impurities “should not stop taking their medications”. They are advised to contact their healthcare provider, to determine if the product they are using is affected by the recall.
Lina Adams
