Ingredient in certain blood pressure medicines could cause cancer/ Канцероген в лекарствах
Source: Raycom images
FDA RECALL: Ingredient in certain blood pressure medicines could cause cancer
Publiched: Monday, July 16th 2018, 12:00 pm PDT. Edited: Monday, July 16th 2018, 2:24 pm PDT.
By WBRC Staff.
BIRMINGHAM, AL (WBRC) -
The U.S. Food and Drug Administration (FDA) announced a voluntary recall of several medicines containing the active ingredient valsartan.
Valsartan is used to treat high blood pressure and heart failure.
The FDA says the recall is due to an impurity, N-nitrosodimethylamine (NDMA), that was found in the recalled products. Not all products containing valsartan are being recalled. NDMA is classified as a probable cancer-causing ingredient, based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, according to the FDA.
FDA объявило о добровольном отзыве нескольких медикаментов, содержащих активный ингредиент Валсартан (Valsartan). Он используется для лечения высокого артериального давления и сердечных заболеваний. Отзыв лекарств произошёл по причине загрязнения их Н-нитрозодиметиламином (N-nitrosodimethylamine (NDMA)), обнаруженным в отозванных медикаментах. По результатам проведенных лабораторных тестов NDMA классифицируется как ингредиент, который может вызвать заболевание раком. Не все препараты, содержащие Валсартан подверглись отзыву, а только произведенные несколькими компаниями, приведёнными в списке ниже.
Этими компаниями являются:
Major Pharmaceuticals
Solco Healthcare
Teva Pharmaceuticals Industries Ltd.
Recalled Medicines
Medicine
Company
Valsartan
Major Pharmaceuticals
Valsartan
Solco Healthcare
Valsartan
Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ)
Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)
Teva Pharmaceuticals Industries Ltd.
The companies listed in the chart above are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API, and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products, according to the FDA.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Information from the FDA for health care professionals and patients:
• Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
• To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
• If a patient is taking one of the recalled medicines listed above, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA's website.
• Patients should also contact their health care professional if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
Investigation into this matter is ongoing.
Copyright 2018 WBRC. All rights reserved.
Read full article at: http://www.14news.com/story/38656077/fda-recall-ingredient-in-certain-blood-pressure-medicines-could-cause-cancer .
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