Pfizer Recall: Another Blood Pressure Drug Pulled Over Cancer Risk Concerns

Pfizer is voluntarily recalling its blood pressure medication, Accupril, because of the presence of an impurity that may increase the risk of cancer if exposed to above acceptable daily intake (ADI) levels for a long time.

Pfizer is recalling five lots of its Accupril (Quinapril HCl) tablets, which are used to lower blood pressure, because of the presence of the nitrosamine Nnitroso-quinapril above the ADI. This was discovered during recent testing, announced the company on U.S. Food and Drug Administration's (FDA) website.

Impurities called nitrosamines are actually quite common in food and water, and even in vegetables and dairy products. In fact, according to the FDA, "everyone is exposed to some level of nitrosamines." However, if people are exposed to it at above the acceptable levels for a prolonged period of time, the impurity can increase the risk of cancer.

"(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 said "there is no immediate risk" to the patients who are taking the medication. So far, it has not received any reports of adverse events related to the recalled tablets.

The recall affects five lots of Accupril tablets (Quinapril HCl Tablets) in 10 mg, 20 mg and 40 mg. They were distributed across the U.S. and also in Puerto Rico from December 2019 till this month.

Consumers can find the NDC, Lot Number and Expiration Dates of the recalled products on both the FDA and Pfizer websites. Photos of the packaging are also available on the FDA website.

Pfizer has also recalled all lots of Accupril in Canada due to a nitrosamine impurity.

Patients taking the product should consult with their healthcare provider or pharmacy to figure out if the product they have is affected. The FDA also stresses that those who are taking prescription medications with a possible nitrosamine impurity should not stop taking their medications. Instead, they should talk to their health care provider about possible concerns or medication alternatives.

"Don't abruptly stop taking your prescription medications without first talking to your health care provider," noted the FDA. "Your health care professional has a more complete picture of your health and health history and can help you make the best decisions for your care."

The latest action came just a month after Pfizer recalled certain lots of Accuretic, another hypertension medication, over similar impurity concerns.

"Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process," the company said at the time. "Pfizer has notified direct consignees by letter to arrange for the return of any recalled product."