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Three different companies recalled heart medications containing valsartan, an active ingredient, fearing that the drugs could be contaminated with a carcinogen that has been around for at least the last four years, according to the US Food and Drug Administration . The voluntary recalls were motivated by the discovery that valsartan produced in a particular Chinese facility contained a probable human carcinogen, N-nitrosodimethylamine (NDMA).
Contamination is attributed to changes in the manufacturing process of the facility since 2012, according to an opinion of the European Medicines Agency. The FDA told Drugwatch, "The amount of impurity varies in the batches of the company (active pharmaceutical ingredient), but we believe that some levels of impurity may have been present in products containing valsartan for four years. "
Valsartan medications are used to treat high blood pressure and heart failure.
Three pharmaceutical companies involved in the recall
The FDA says the recall does not affect any drugs containing valsartan. The recall relates to valsartan supplied by Zhejiang Huahai Pharmaceuticals, Linhai, China
The companies and drugs concerned are:
- Major Pharmaceutical Products (Teva Pharmaceuticals USA) – Valsartan 80 mg and 160 mg Products
- Solco Healthcare ( Prinson Pharmaceuticals) – Valsartan 40 mg, 80 mg, 160 mg and 320 mg; and valsartan / HCTZ 80 mg / 12.5 mg, 160 mg / 12.5 mg, 160 mg / 25 mg, 320 mg / 12.5 mg and 320 mg / 25 mg of products
- Actavic (Teva Pharmaceuticals Industries Ltd .) – Valsartan 40 mg 80 mg, 160 mg and 320 mg; and valsartan / HCTZ 80 mg / 12.5 mg, 160 mg / 12.5 mg, 160 mg / 25 mg, 320 mg / 12.5 mg and 320 mg / 25 mg of products
Click here for a detailed list products concerned. You can compare your prescription with this list to determine if your medicine has been recalled. If you are not sure, contact your pharmacist.
"We have carefully evaluated drugs containing valsartan sold in the United States, and we have found that valsartan sold by these specific companies does not meet our safety standards," said Dr. Janet Woodcock, director of Drug Evaluation and Research Center of the FDA. "That's why we asked these companies to take immediate action to protect patients."
The FDA recommends that patients who can take the recalled medications continue to take them until They are replaced or their treatment is different.
Adverse effects of valsartan reported to the FDA
Contacted by Drugwatch, the FDA had no information on the number or percentage of valsartan medications or patients affected by the recalls.
The agency said it received reports of adverse events. patients using valsartan medications and 'is currently assessing the nature of the events and determines what link they might have with the products affected by the recall. A preliminary review of these reports did not identify any new security issues. "
The agency did not disclose in its e-mail response to Drugwatch how many reports it has received." A search in the FDA's online adverse reaction reporting system found more than 19 reports. 000 serious reports, including more than 2,800 deaths related to valsartan dating back to 2009.
The most common type of reporting was high blood pressure.There were 150 reports of liver injury, including 29 reports of metastases. to the liver
Remember affected Europe, Asia and Canada
Previously, valsartan products were recalled in 23 countries in Europe, as well as in Japan, Canada, China, Hong Kong and Taiwan.
According to the Environmental Protection Agency, N-nitrosodimethylamine is a probable carcinogen to humans.It is mainly used as a research chemical.It is also used as an antioxidant, such as additive for lubricants and softeners for copolymers. It was used in the manufacture of rocket fuels.
Short-term exposure can damage the liver. Long-term exposure can cause liver damage and low platelet count.
Animal studies have suggested that prolonged ingestion and inhalation of NDMA may cause an increase in tumors, including in the liver, kidneys and lungs. The exposure occurs in industrial environments, including tannery, fish processing, dye and surfactant industries.
Chinese manufacturer makes other heart drugs
Some foods contain a small amount of NDMA. This includes deli products and smoked fish.
According to a Bloomberg company profile, Zhejiang Huahai Pharmaceutical Co. also manufactures drugs for the heart captopril, enalapril and lisinopril.
The company's website states that it is the largest supplier of these products. "Products in the world, with the" leading products "being captopril and enalapril.
The company informed regulators that it had discovered residues of NDMA in its valsartan supplies after the adoption of a new manufacturing process. disclosed on the Shanghai Stock Exchange, she sold about $ 50 million of the ingredient in 2017 and raised $ 20.4 million of drugs containing
The FDA states that it is conducting a survey on the NDMA levels in the recalled products.It also assesses the possible effect on the patients who took the drugs and the measures that can be taken. taken to eliminate or reduce impurities from future batches of the company.
Harry Lever, a cardiologist at the Cleveland Clinic, told The New York Times that he was concerned about quality control Generic drugs like valsartan, made in China and India. He thinks there should be more transparency on the part of manufacturers as to the manufacture of their active ingredients.
"This is not just about Valsartan," Lever told The Times. "It becomes very difficult for me to write prescriptions at all.There are so many drugs coming in from India and China and the companies are buying and selling and you do not know what. to do. "
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