Pfizer this week issued a voluntary recall of medications used to treat high blood pressure due to an inordinate amount of ​​nitrosamines in the products, which can increase the risk of cancer should an individual be exposed to a high amount over an extended period of time. 

What You Need To Know

  • Pfizer this week issued a voluntary recall of medications used to treat high blood pressure due to an inordinate amount of ​​nitrosamines in the products

  • According to the FDA, nitrosamines are commonly found in “water and foods, including cured and grilled meats, dairy products and vegetables"

  • The FDA says nitrosamine impurities "may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time"

  • Pfizer said in a press release there is "no immediate risk to patients taking this medication"

The pharmaceutical company recalled six lots of Accuretic tablets, a hypertension medication distributed by Pfizer; it also recalled one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets, which are generic versions of the drug distributed by Greenstone. 

According to the FDA, nitrosamines are commonly found in “water and foods, including cured and grilled meats, dairy products and vegetables,” adding “everyone is exposed to some level of nitrosamines” on a near-daily basis. 

In conjunction with other international health organizations, the FDA recommends specific intake limits for a number of different nitrosamine compounds, with none exceeding 96 ng/day.

“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but 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,” the FDA says in part. 

Pfizer’s release did not identify how much – or what kind – of nitrosamines were identified, and the company said “there is no immediate risk to patients taking this medication.” Individuals taking the medications should consult with their doctor to see if they have a recalled batch, and should discuss alternative treatment options. 

The recalled lots were distributed across the United States and Puerto Rico between November 2019 to March 2022, with expiration dates ranging from April 2022 to August 2024. 

Nitrosamines can be found in drugs for a number of reasons, including a company’s manufacturing process, the conditions in which the medication is stored and other environmental conditions, per the FDA.