A global pharmaceutical firm has recalled four lots of blood pressure pills in the US after they were found to contain a cancer-causing chemical.
Quinapril is prescribed to around a million Americans each year to treat hypertension and heart failure. However, recent testing at various manufacturing facilities uncovered excessive amounts of an impurity known as nitrosamine, according to the Food and Drug Administration (FDA).
The company that issued the recall, Indian-based Lupin Pharmaceuticals, has warned distribution centers and pharmacies to stop doling out the pills from certain batches.
Lupin’s recall applies to 20 mg and 40 mg doses distributed between March 2021 and September 2022, which have expiration dates from December 2022 to March 2024.
The latest quinapril recall comes more than half a year after Pfizer pulled five batches of its version of the drug off the market over similar nitrosamine concerns.
Quinapril treats high blood pressure in roughly 1 million Americans, but certain batches had nitrosamine which when taking over a long period of time at higher-than-acceptable doses can cause cancer
Quinapril blocks a substance in the body that causes blood vessels to tighten. As a result, quinapril relaxes the blood vessels, thus lowering blood pressure and increasing the supply of blood and oxygen to the heart
The FDA stated that no illness related to the medication has yet been reported and that the marketing of the quinapril tablets ended in September.
The agency said in a statement: ‘Wholesalers, distributors and retailers that have Quinapril Tablets USP, 20mg, and 40mg that are being recalled should discontinue distribution of the recalled product lots immediately.’
The medication helps with hypertension by blocking a substance in the body that causes blood vessels to tighten.
As a result, quinapril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
But Lupin, which is headquartered in Mumbai, discovered that four lots of the drugs contained an excess amount of the impurity nitrosamine.
Nitrosamines come from chemical reactions and can form in drugs during manufacturing.
The FDA has warned that concentrations of the compound in a product should never exceed 26.5 nanograms per day.
Nitrosamine is a naturally occurring compound found in water and certain foods such as processed meats, dairy products, and vegetables.
Lupin did not disclose the level of nitrosamines in its tablets but acknowledged that they were beyond what the FDA considers acceptable.
The FDA is advising those who take quinapril tablets to continue taking their medication until they contact a medical professional.
Suddenly stopping medication can cause side effects and in very low levels, nitrosamines are not dangerous.
The FDA noted that a person who takes a drug with a level of nitrosamine below the acceptable threshold every day for 70 years does not have a heightened risk of developing cancer.
But hypertension is a chronic disease; for some, the compound in the drug could spell severe trouble. Lupin’s product is just the latest version of quinapril to be recalled for the same contamination.
In September, Lupin Pharmaceuticals discontinued manufacturing of the drug though it is unclear whether that decision was due to a contamination issue.
People taking the drug should consult the list of lot numbers recalled on the FDA website to ensure their pills are not contaminated.
Patients in the clear should continue taking their medication and talk to their pharmacist or physician about an alternative treatment.
Hypertension is a health problem that affects roughly 116 million Americans – 47 percent of the adult population.
Blood pressure describes the strength with which your blood pushes on the sides of your arteries and is measured in millimeters of mercury (mmHg).
A reading consists of systolic pressure (the top number), which is the pressure in the arteries when the heart beats; and diastolic (the bottom number), which is the pressure in the arteries when the heart rests between beats.
If either figure is too high, this can place a strain on the arteries and major organs such as the heart. High blood pressure also increases the risk of blood clots, which can curb the brain’s oxygen flow, resulting in a stroke.
Anyone who has questions regarding the Quinapril recall is being told by the FDA to contact Inmar Rx Solutions Inc. at (877) 538-8445 from Monday–Friday, 9 a.m. to 5 p.m. EST.
What does it mean to have hypertension?
High blood pressure, or hypertension, rarely has noticeable symptoms. But if untreated, it increases your risk of serious problems such as heart attacks and strokes.
More than 116 million US adults have high blood pressure, although many won’t realize it or get treatment.
The only way to find out if your blood pressure is high is to have it checked.
Blood pressure is recorded with two numbers. The systolic pressure (higher number) is the force at which your heart pumps blood around your body.
The diastolic pressure (lower number) is the resistance to the blood flow in the blood vessels. They’re both measured in millimetres of mercury (mmHg).
As a general guide:
If your blood pressure is too high, it puts extra strain on your blood vessels, heart and other organs, such as the brain, kidneys and eyes.
Persistent high blood pressure can increase your risk of a number of serious and potentially life-threatening conditions:
- heart disease
- heart attacks
- heart failure
- peripheral arterial disease
- aortic aneurysms
- kidney disease
- vascular dementia