Four lots of blood pressure medication Quinapril have been voluntarily recalled after concern about ingredients causing an increased risk of cancer. Lupin Pharmaceuticals Inc.'s Quinapril tablets might have more than the accepted daily intake level of nitrosamine impurity, N-Nitroso-Quinapril, which the company stresses is also found in dairy products, grilled meats, and vegetables. "Everyone is exposed to some level of nitrosamines," the recall states. "These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time."
"Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level," says the FDA in an official statement. "To date, Lupin has received no reports of illness that appear to relate to this issue. Patients taking Quinapril Tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment."
According to the CDC, 47% of US adults have high blood pressure, or hypertension. Left untreated, it can lead to serious health issues. "Blood pressure is reported as the systolic pressure over diastolic pressure (eg, 120/70 or '120 over 70')," says Johannes FE Mann, MD. "Untreated high blood pressure increases the strain on the heart and arteries, eventually causing organ damage. High blood pressure increases the risk of heart failure, heart attack (myocardial infarction), stroke, and kidney failure." While there is no cure for high blood pressure, certain lifestyle changes can help lower it. Always consult with a doctor before making any changes. Read on for more about this recall, and to see the top 5 wats to keep blood pressure down naturally.
Why Blood Pressure Medications are So Important
Blood pressure medications work by decreasing the resistance of blood vessels, which helps to lower the blood pressure. There are several different types of blood pressure medications, including:
Angiotensin-converting enzyme (ACE) inhibitors: These medications work by blocking the production of a substance in the body called angiotensin II, which can constrict blood vessels and increase blood pressure.
Angiotensin receptor blockers (ARBs): These medications work in a similar way to ACE inhibitors, but they block the action of angiotensin II rather than inhibiting its production.
Beta blockers: These medications work by blocking the effects of the hormone epinephrine (also known as adrenaline), which can cause an increase in heart rate and blood pressure.
Calcium channel blockers: These medications work by blocking the movement of calcium into the cells of the heart and blood vessels, which can help to relax the muscles of the blood vessels and lower blood pressure.
Diuretics: These medications help to remove excess fluid from the body, which can help to lower blood pressure.
It's important to take blood pressure medications exactly as prescribed by your doctor. If you have any questions or concerns about your medication, you should talk to your doctor or pharmacist.
What the Recall Said
Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.
Lupin discontinued the marketing of Quinapril tablets in September 2022.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below:
Quinapril Tablets USP, 20mg / Lot No. G102929 / Expiry 04/2023 / NDC 68180-558-09 (90's) / UPC 368180558095 / Distribution Date 03/15/2021
Quinapril Tablets USP, 40mg / Lot No. G100533, G100534, G203071 / Expiry 12/2022, 12/2022, 03/2024 / NDC 68180-554-09 (90's)/ UPC 368180554097 / Distribution Date 09/01/2022
Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.
Patients taking, Quinapril Tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
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.
Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (877) 538-8445 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Tip for Lowering Blood Pressure: Get Moving
Regular exercise can be highly effective in supporting healthy blood pressure, experts say. "Try to aim for at least 150 minutes of exercise per week of moderate-intensity physical activity, such as brisk walking," says Colin A. Craft, MD, physician at Penn Heart and Vascular Center Washington Square. Any aerobic activity will be beneficial, even just walking.
Research shows that morning walks combined with movement throughout the day can have a significant reduction on blood pressure levels. "For both men and women, the magnitude of reduction in average systolic blood pressure following exercise and breaks in sitting, approached what might be expected from antihypertensive medication in this population to reduce the risk of death from heart disease and stroke," says Michael Wheeler, B.Sc., lead author of the study. "However, this reduction was greater for women."
Tip for Lowering Blood Pressure: Healthier Eating
Research shows lifestyle changes such as following the DASH diet (Dietary Approaches to Stop Hypertension), rich in fruits, vegetables, and whole grains, can help lower blood pressure. "Lifestyle modifications, including healthier eating and regular exercise, can greatly decrease the number of patients who need blood pressure-lowering medicine. That's particularly the case in folks who have blood pressures in the range of 130 to 160 mmHg systolic and between 80 and 99 mmHg diastolic," says Alan Hinderliter, M.D., associate professor of medicine at University of North Carolina in Chapel Hill.
"Your food choices can have a significant impact on your blood pressure in positive and negative ways," says Anne Mullens, BSc, BJ. "Eating a healthy diet rich in vegetables, fruit, whole grains, nuts, seeds, legumes, fish, lean meats, and low-fat dairy can help manage blood pressure. On the other hand, eating a lot of red meat, fried foods, salt, and added sugars can contribute to high blood pressure."
Tip for Lowering Blood Pressure: Be Mindful Of Alcohol Intake
"Drinking too much alcohol can raise blood pressure to unhealthy levels," says Francisco Lopez-Jimenez, M.D. "Having more than three drinks in one sitting temporarily raises blood pressure. Repeated binge drinking can lead to long-term increases in blood pressure. Heavy alcohol users who cut back to moderate drinking can lower their top number in a blood pressure reading (systolic pressure) by about 5.5 millimeters of mercury (mm Hg) and their bottom number (diastolic pressure) by about 4 mm Hg."
Doctors recommend that people with high blood pressure lower their intake. "If you have high blood pressure, avoid alcohol or drink alcohol only in moderation," says Dr. Lopez-Jiminez. "For healthy adults, that means up to one drink a day for women and up to two drinks a day for men. Keep in mind that alcohol contains calories and may cause weight gain. Weight gain is a risk factor for high blood pressure. Alcohol may interact with certain blood pressure medications. It may affect the level of the medication in the body or increase side effects.
Tip for Lowering Blood Pressure: Don't Smoke
Smoking is linked to dangerously high blood pressure, experts say. Research shows even non-smokers benefit when smoking is banned from public places. "We found that nonsmoking adults in the study who lived in areas with smoke-free laws in restaurants, bars or workplaces had lower systolic blood pressure by the end of the follow-up period compared to those who lived in areas without smoke-free laws," says Stephanie Mayne, Ph.D., research scientist at PolicyLab and the Center for Pediatric Clinical Effectiveness at Children's Hospital of Philadelphia.
"Quitting smoking can be a challenge, but the benefits are worth it. Many of the diseases treated in our community are in some way related to tobacco use. If you are a smoker, the best thing you can do, is quit," says Rob Williamson, RN, BSN, CRN, CTTS, Pulmonary Care Management Consultant and Certified Tobacco Treatment Specialist with the Genesis HealthCare System.
Tip for Lowering Blood Pressure: Get Your Sleep
Not getting enough sleep is linked to high blood pressure, experts say. "Sleep experts recommend that adults get 7 to 8 hours of sleep each night," says Dr. Lopez-Jiminez. "Getting less than six hours of sleep is known to be bad for overall health. Stress, jet lag, shift work and other sleep disturbances make it more likely to develop heart disease and risk factors for heart disease, including obesity and diabetes. A regular lack of sleep may lead to high blood pressure (hypertension) in children and adults.
"The less you sleep, the higher your blood pressure may go. People who sleep six hours or less may have steeper increases in blood pressure. If you already have high blood pressure, not sleeping well may make your blood pressure worse. It's thought that sleep helps the body control hormones needed to control stress and metabolism. Over time, a lack of sleep could cause swings in hormones. Hormone changes can lead to high blood pressure and other risk factors for heart disease."