A global pharmaceutical company has recalled four batches of blood pressure pills in the US after they were found to contain a cancer-causing chemical.
Quinapril is prescribed to about one million Americans each year to treat high blood pressure and heart failure. However, recent tests at several manufacturing facilities have found excessive levels of an impurity called nitrosamine, according to the Food and Drug Administration (FDA).
The company that issued the recall, Lupine Pharmaceuticals in India, warned distribution centers and pharmacies to stop distributing certain batches of pills.
Lupine’s recall applies to doses of 20 mg and 40 mg distributed between March 2021 and September 2022, with an expiration date from December 2022 to March 2024.
The latest quinapril recall comes more than six months after Pfizer pulled five batches of its version of the drug because of similar nitrosamine concerns.
Quinapril treats high blood pressure in about 1 million Americans, but certain groups contain nitrosamines, which can cause cancer if taken for long periods in higher than acceptable doses
Quinapril blocks a substance in the body that causes blood vessels to constrict. As a result, quinapril relaxes blood vessels, lowers blood pressure and increases the flow of blood and oxygen to the heart
The FDA said no illness has yet been reported related to the drug and marketing of the quinapril tablets was discontinued in September.
The agency said in a statement: “Wholesalers, distributors and retailers who have recalled Quinapril Tablets USP, 20 mg and 40 mg should immediately stop selling the recalled lot of products.”
The drug helps with high blood pressure by blocking a substance in the body that causes blood vessels to constrict.
This causes quinapril to relax the blood vessels. It lowers blood pressure and increases the flow of blood and oxygen to the heart.
Why you may have hypertension and not even know it
Millions of people may not know they have high blood pressure because, according to a study from Oxford University, their high blood pressure is only at its highest at night.
But Lupin, headquartered in Mumbai, found that four batches of the drugs contained an excessive amount of the impurity nitrosamine.
Nitrosamines come from chemical reactions and can occur during the manufacture of medicines.
The FDA has warned that levels of the compound in any product should not exceed 26.5 nanograms per day.
Nitrosamine is a naturally occurring compound found in water and certain foods, such as processed meats, dairy and vegetables.
Lupine did not disclose the levels of nitrosamines in its tablets, but admitted they were above what the FDA considers acceptable.
The FDA advises those taking quinapril tablets to continue taking their medication until they consult a doctor.
Stopping medication suddenly can cause side effects, and nitrosamines are harmless in very low concentrations.
The FDA found that a person who takes a drug with nitrosamine levels below the acceptable threshold daily for 70 years has no increased risk of developing cancer.
But high blood pressure is a chronic disease; For some, the compound in the drug can cause serious problems. Lupine’s product is just the latest version of Quinapril, which is being recalled due to the same contamination.
In September, Lupine Pharmaceuticals stopped manufacturing the drug, although it is unclear whether that decision was due to a contamination issue.
People taking the drug should check the list of recalled lot numbers on the FDA’s website to make sure their pills are not contaminated.
Patients who have been weaned should continue taking their medication and talk to their pharmacist or doctor about alternative treatment.
Hypertension is a health problem that affects approximately 116 million Americans – 47 percent of the adult population.
Blood pressure describes the force with which your blood pushes against the sides of your arteries and is measured in millimeters of mercury (mmHg).
A measurement consists of systolic pressure (top number), the pressure in the arteries when the heart beats; and diastolic (the bottom number), which is the pressure in the arteries when the heart is resting between beats.
Too high a value can put a strain on the arteries and important organs such as the heart. High blood pressure also increases the risk of blood clots, which slow the flow of oxygen to the brain and can lead to a stroke.
Anyone with questions about the Quinapril recall is directed by the FDA to contact Inmar Rx Solutions Inc. can be reached at (877) 538-8445 Monday through Friday, 9:00 AM to 5:00 PM EST.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
