Lupin Pharmaceuticals Inc. voluntarily recalled four lots of blood pressure medication Quinapril last week due to impurity, the U.S. Food and Drug Administration (FDA) announced.
Four lots of blood pressure medication Quinapril were recalled due to increased cancer risk.
Recent testing found that Quinapril tablets may have a dangerous level of nitrosamine impurity.
Despite being present in many foods and water, nitrosamines are only expected to lead to cancer risks in high doses.
Drug manufacturer Lupin Pharmaceuticals Inc. voluntarily recalled four lots of Quinapril, sold in 20 mg and 40 mg, last week over concerns it could increase the risk of cancer.
Recent testing found that Quinapril tablets may contain a level of nitrosamine impurity (N-Nitroso-Quinapril) above the acceptable daily intake amount.
Nitrosamines are found in water and many foods, such as cured and grilled meats, dairy products, and vegetables. Everyone consumes some amount of nitrosamines. However, nitrosamines are harmful in high doses.
“[Nitrosamine] impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the recall says.
Quinapril tablets are used to treat hypertension by working to lower blood pressure. The medicine works by blocking a substance in the body that makes blood vessels tighten called angiotensin-converting enzyme (ACE).
When ACE is blocked, the blood vessels relax, which helps lower blood pressure. It also increases the supply of blood and oxygen to the heart.
High blood pressure, or hypertension, happens when your arteries have too much resistance to blood flow. If the pressure gets too high, it could be harmful to your health. Lowering high blood pressure decreases the risk of fatal and nonfatal heart problems, especially strokes and heart attacks.
Nearly half of adults in the United States (47%, or 116 million) report having hypertension. In 2020, Quinapril was one of the most commonly prescribed medications in the U.S., with more than one million prescriptions.
Quinapril Tablets USP 20mg and 40mg come in 90-count bottles and are sent to wholesalers, drug stores, mail-order pharmacies, and supermarkets all over the U.S.
The lots affected by the recall were sold between March 2021 to September 2022. The expiration dates on these lots range from December 2022 to March 2024.
To learn more about the affected lots, see the FDA recall.
Patients already taking the drug don't have to stop immediately, but they should talk to their doctor about an alternative treatment.
Lupin has not received any reports of illness that appear to relate to the recall.