Why Pfizer Blood Pressure Drugs Were Recalled From The U.S. Market
High blood pressure is a common condition that affects the body’s arteries. It’s also called hypertension. If you have high blood pressure, the force of the blood pushing against the artery walls is consistently too high. The heart has to work harder to pump blood.
Blood pressure is measured in millimeters of mercury (mm Hg). In general, hypertension is a blood pressure reading of 130/80 mm Hg or higher. The United States Preventive Services Task Force (USPSTF) estimates that high blood pressure affects around 45% of adults in the U.S.
There are ways of managing high blood pressure or hypertension. The condition does not often cause symptoms, but regular screening can help a person know if preventive measures are necessary. Dozens of different medications can help treat high blood pressure. Called antihypertensives, these drugs are divided into many different categories, each of which works differently and causes different side effects.
High blood pressure can lead to many serious health problems, such as heart attack, heart failure, stroke, and kidney disease. Treating high blood pressure early is important in preventing these and other problems.
Pfizer Range of Blood Pressure Drugs
Pfizer Inc. is one of the world’s biggest pharmaceutical and biotechnology corporations that produce one of the widest ranges of blood pressure medications. Headquartered on 42nd Street in Manhattan, New York City, the company is known globally for amlodipine (Norvasc), an antihypertensive and antiischemic drug, it discovered and patented in 1982. However, the reputation of the drug company came crashing recently after a voluntary recall of some types of blood pressure drugs in March and April 2022.
Why Pfizer Blood Pressure Medication Was Recalled From The U.S Market
Pfizer announced a voluntary recall of some types of blood pressure drugs due to the presence of N-nitroso-quinapril a type of nitrosamine that is present as an impurity and has the potential to cause cancer. Nitrosamine is a general term used to designate a vast group of N-nitroso compounds (NOCs), bearing a common functional >N–N=O. group. The NOCs can be divided into two classes: N-nitrosamines and N-nitrosamides and related compounds.
Exposure to high levels of nitrosamines over time may increase the risk of cancer. Over 300 nitrosamines are known, many of which are highly potent mutagenic carcinogens. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines.
The FDA has been investigating the presence of nitrosamines, in some types of medications since 2021, and has been working in collaboration with regulatory counterparts around the world, to set internationally-recognized acceptable daily intake limits for nitrosamines. If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate.
The list of drugs withdrawn from the market by Pfizer due to potential N-nitroso-quinapril contamination includes certain batches of :
- Accupril (quinapril hydrochloride) tablets
- Accuretic (quinapril hydrochloride plus hydrochlorothiazide) tablets distributed by Pfizer, as well as two related generic formulations distributed by Greenstone.
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
| NDC | Lot Number | Expiration Date | Strength | Configuration/Count |
|---|---|---|---|---|
| 0071-3112-23 | FG5379 | 08/2024 | 10/12.5 mg | 1 x 90 count bottle |
| 0071-0222-23 | EA6686 | 04/2022 | 10/12.5 mg | 1 x 90 count bottle |
| 0071-5212-23 | FG5381 | 08/2024 | 20/12.5 mg | 1 x 90 count bottle |
| 0071-0220-23 | EA6665 | 04/2022 | 20/12.5 mg | 1 x 90 count bottle |
| 0071-0220-23 | CN0640 | 04/2022 | 20/12.5 mg | 1 x 90 count bottle |
| 0071-0223-23 | ET6974 | 02/2023 | 20/25 mg | 1 x 90 count bottle |
quinapril and hydrochlorothiazide tablets, 20/25 mg
quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
| NDC | Lot Number | Expiration Date | Strength | Configuration/Count |
|---|---|---|---|---|
| 59762-5225-9 | FE3714 | 02/2023 | 20/25 mg | 1 x 90 count bottle |
| 59762-0220-1 | DN6931 | 03/2023 | 20/12.5 mg | 1 x 90 count bottle |
| 59762-0220-1 | ED3904 | 03/2023 | 20/12.5 mg | 1 x 90 count bottle |
| 59762-0220-1 | ED3905 | 03/2023 | 20/12.5 mg | 1 x 90 count bottle |
| 59762-0223-1 | DP3414 | 02/2023 | 20/25 mg | 1 x 90 count bottle |
Even though the drugmaker 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, the recall has raised serious concerns about the safety of Pfizer blood pressure medications among patients. Pfizer Canada also recalled all lots of three doses of Accupril after finding the same impurity to be above acceptable levels. You may also find useful information on Why Is Amlodipine Banned In Canada?
