Thai FDA Recalls Blood-pressure Drugs Due to Cancer-Risk Ingredient

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THE FOOD and Drug Administration (FDA) has recalled immediately five registered drugs to control blood pressure because of a potentially dangerous key ingredient.

The Thai FDA is the government department responsible for issuing licenses to importers and producers of medicines, food, food supplements, medical devices, as well as other potentially toxic substances, so that those products can be imported and sold in Thailand. “It contains something that poses cancer risk,” said FDA Secretary-general Dr Wanchai Sattayawuthipong. The recalled products are: Valatan 80 drug registration No 1A/54 (NG); Valatan 160 drug registration No 1A 10/54; Valsarin 80 drug registration No 1A 4/60; Valsarin 160 drug registration No 1A 5/60; Valsarin 320 drug registration No 1A 6/60. He urged people to check if they were using the drugs being recalled. “If yes, please return them to the hospital or pharmacy that gave them to you,” Wanchai said. “These drugs must be destroyed.” “Urgent alerts have already been issued to all relevant authorities, too,” he said. FDA Secretary-general Dr Wanchai Sattayawuthipong Valsartan, an angiotensin II receptor blocker, is usually prescribed for patients with hypertension. “Patients can continue to use drugs containing valsartan as long as they are not the ones that are now being recalled. Other batches are not contaminated,” Wanchai explained. Their manufacturing processes are not at fault, but an impurity has been introduced during the production of key ingredient valsartan by its supplier – China-based Zhejiang Huahai Pharmaceuticals. Recall of drugs containing valsartan are now underway in 22 countries around the world. The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) 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. The FDA (US) says that 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 packaging. If the information is not provided, patients should contact the pharmacy or medical facility that dispensed the medicine. 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.

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