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NDMA, which was found in the valsartan products, could cause cancer, according to lab tests. “The presence of NDMA was unexpected and is thought (Whatsapp Status Video Download) to be related to changes in the way the active substance was manufactured,” the FDA said in a statement.
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Valsartan Major Pharmaceuticals
Valsartan Solco Healthcare
Valsartan Teva Pharmaceuticals
Valsartan/Hydrochlorothiazide (HCTZ) Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals
All of the companies say the possibly contaminated valsartan was supplied by one outside company. But not all of their valsartan drugs feature material from (Whatsapp Status Video Download) that company, which the FDA did not name. The supplier has stopped distributing its product, known as the valsartan active pharmaceutical ingredient, and the FDA is working with the affected companies to lessen or remove it from future products.
The FDA is investigating how much NDMA is in the recalled products and is trying to find out the possible effects on patients who have been taking them.
“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” FDA Commissioner Scott Gottlieb, MD, said in the statement.
Because valsartan is used to treat serious medical conditions, patients taking the recalled products should continue taking their medicine until they have a replacement product, the FDA advises.
Patients should contact their doctor or pharmacist if their medication is part of the recall.
Earlier this month, European authorities recalled drugs that had valsartan that were supplied by a Chinese drugmaker over concerns they may contain NDMA, as reported by Medscape Medical News.
Recalls of certain drugs containing (Whatsapp Status Video Download) heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the U.S., as the FDA sought voluntary actions to take some affected drugs off the shelves due to the potential cancer risk.
The recall, like the one announced earlier by the European Medicines Agency, is because the API in those drugs was unexpectedly tainted with N-nitrosodimethylamine (NDMA), a substance that could cause cancer.
The recalled finished products in the U.S. include all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco. Valsartan’s original developer Novartis previously told FiercePharma none of its valsartan products marketed in the U.S.—branded or generic— are affected.
“We have carefully assessed the valsartan-containing medications sold in the (Whatsapp Status Video Download) 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, in a statement.
In Europe, Novartis is recalling Sandoz’ valsartan and valsartan HCT film-coated tablets in 23 countries. Teva, Stada, Dexcel Pharma and Accord Healthcare are among (Whatsapp Status Video Download) affected by the EU recalls. Drugmakers selling valsartan products made of Huahai’s API are also recalling their meds in Japan, Canada, Chinese mainland, Hong Kong and Taiwan.
China’s Huahai suspended manufacturing and supply to those markets and informed regulatory agencies after it discovered the residue in its supplies. It attributed the impurity to a new manufacturing (Whatsapp Status Video Download) process it recently adopted. The FDA said it is currently investigating the levels of NDMA in the recalled products, assessing the effect on patients and working with Huahai to solve the problem in future batches.
NDMA has been classified by the World Health Organization’s International Agency for Research on Cancer as a probable carcinogen to humans. There is ample evidence to prove it is toxic to animals, but not enough data can determine a quantitative risk of cancer in humans.(Whatsapp Status Video Download)
Based in China’s Zhejiang Province, Huahai is one of the world’s major valsartan API suppliers. According to the company’s disclosures to the Shanghai Stock Exchange, in 2017, it sold CNY 328 million (about $50 million) worth of the ingredient in 2017 and collected $20.4 million from valsartan-containing drugs.
Because valsartan is a common medicine to help patients with high blood pressure and to reduce the chance of heart attack, the FDA suggests patients taking the recalled medicine to continue taking their medicine until a replacement is in place. The agency said its drug shortages team is also trying to ensure an adequate supply of unaffected alternatives.(Whatsapp Status Video Download)
he U.S. Food and Drug Administration has recalled a common drug used to treat heart conditions after it was found to contain a chemical linked to cancer. The U.S. decision came a week after 22 other countries had recalled the medication.
The FDA flagged concerns about valsartan, which is used to treat high blood pressure and heart failure, on July 13. Officials found traces of the chemical compound N-nitrosodimethylamine (NDMA) in the recalled products.
NDMA is a carcinogen, a substance that could cause cancer. The natural compound was formerly used to make liquid rocket fuel and antioxidants but is currently used only for research purposes.
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