The Food and Drug Administration announced only a recall of Valsartan, a potentially life-threatening blood pressure medicine, following the discovery…
The Food and Drug Administration announced only a recall of Valsartan, a potentially life-threatening blood pressure medicine, following the discovery of a carcinogenic contamination found in certain rates. This is the third recall for this type of medication in 2018.
Teva Pharmaceuticals has recalled amlodipine / valsartan and amlodipine / valsartan / hydrochlorothiazide combination tablets, medicines commonly used to treat high blood pressure.
The recall began after high levels of an active ingredient in Valsartan, N-nitroso diethylamine (NDEA), were found in tablets prepared in India. NDEA is a naturally occurring chemical in some foods and can be found in drinking water, air pollution and industrial processes, but it is also classified as a carcinogen, which means that it can cause high levels of cancer.
Less than a month ago, the FDA also announced the withdrawal of Irbesartan tablets, a drug of the same class as Valsartan, which also contained the NDEA ingredient. The tablets were manufactured by ScieGen Pharmaceuticals, a New York-based company with manufacturing relations in India.
In July, the FDA announced another recall of an ingredient in Valsartan called N-nitrosodimethylamine (NDMA). This contaminant, another carcinogen, was noted in medicines manufactured by Zhejiang Huahai Pharmaceuticals in China. The pollution, according to the FDA, was a result of changes in the production process of the company.
“The FDA is committed to maintaining our gold standard for safety and efficiency,” said FDA Commissioner Scott Gottlieb in a statement from July. He added that when the Agency detects quality control problems, they take decisive action to warn the public and remove the product.
What is high blood pressure?
High blood pressure, affecting 75 million adults in the United States, is one of the most common medical conditions. Blood pressure is a measure of how effectively our hearts push blood through our arteries. If the pressure is too low there is a risk that the organs will not get enough blood. If the pressure is too high, there is a risk that the heart will work too hard.
What is normal blood pressure?
Blood pressure measurement is divided into two phases. The first is the pressure when the heart pinches, so-called systolic. The other is the pressure when the heart is relaxing, known as diastolic. If your doctor says your blood pressure is 130/80 – “130” would be systolic and “80” would be diastolic.
While your target blood pressure is often determined by your age and medical condition, most doctors recommend keeping it around 120/80.
Why is my blood pressure high?
It is important to understand that the number will vary throughout the day, but it is normal. High blood pressure can be caused by family history, obesity, smoking, high salt diets, diabetes, lack of exercise or underlying kidney disease. Often it can be controlled by a combination of lifestyle modifications and different medications.
What is Valsartan / Ibresartan?
Valsartan is a high blood pressure medication in a class called angiotensin receptor blockers (ARB). These block a natural hormone called angiotensin II, which works to limit your arteries, which increases your blood pressure. High blood pressure causes stress on your heart and can contribute to heart disease.
What does this memory mean to you?
If you are taking a blood pressure medicine recently recalled, do not stop taking it. Instead, contact your doctor immediately to discuss a replacement drug. The FDA said that the effects of stopping this type of medicine suddenly can lead to increases in blood pressure that could pose additional health risks.
Teva said they have not been informed of any health problems related to pollutants in the recalled drugs.
According to the FDA website, persons with questions should contact Teva on telephone: 888-838-2872 Monday-Friday, 9:00 to 17:00 EST. Voicemail is available 24 hours a day. You can also email them at [email protected].com.
Some Shah, M.D. is an emergency medical practitioner in New York City, and a member of the ABC News Medical Unit.