Carcinogen Concern Leads To Pfizer Drug Recall From The US

Pfizer’s recall saga has now reached the United States, after elevated concentrations of potential carcinogens forced the company to pull multiple products in Canada. After testing revealed quantities of a nitrosamine—Nnitroso-quinapril—above daily recommended limits, Pfizer is recalling five lots of Accupril pills, commonly known as quinapril HCL.

Nitrosamines are found in a wide range of foods, including cured and barbecued meats, dairy products, and vegetables. Everybody is susceptible to nitrosamines in some way, and cancer is only a result of long-term exposure to high levels of nitrosamines. Accupril is a blood pressure medication that has been licenced for the treatment of hypertension. According to Pfizer, it’s also prescribed to treat heart issues as an add-on therapy to diuretics or digitalis.

Pfizer said it had not acquired any safety evidence relating to the recalled medicines as of the week ending 23rd April 22.  Accupril has a 30-year safety track history, according to the company, and it believes the benefits of the drug exceed the dangers based on current research.

Although long-term consumption of Nnitroso-quinapril has been linked to an elevated cancer risk in humans, there is no imminent threat to patients using this drug, Pfizer said in a statement on the FDA’s website. Patients who are presently taking the drugs should discuss alternative therapies with their physician or health care provider. Between December 2019 and April 2022, Pfizer delivered the five Accupril lots across the United States and Puerto Rico.

The 90-count bottles of 10-, 20-, and 40-mg Accupril were slated to expire between the end of March and May of next year. In recent years, nitrosamines have been implicated in a slew of recalls, most prominently of valsartan blood pressure medications and metformin diabetes medications. Pfizer’s Chantix recall in 2021 was likewise driven by an excess of nitrosamines. Meanwhile, Pfizer has also recalled two different batches of blood pressure medicine in Canada because of nitrosamine concerns.

Meanwhile, in Canada, Pfizer recently recalled two separate blood pressure medication batches due to nitrosamine concerns. These medications were Accuretic, for which Pfizer withdrew all lots in Canada, and Inderal, for which Pfizer recalled 15 batches.