FDA recalls blood-pressure drugs due to cancer-risk ingredient
THE FOOD and Drug Administration (FDA) has recalled immediately five registered drugs to control blood pressure because of a potentially dangerous key ingredient.
“It contains something that poses cancer risk,” FDA secretary-general Dr Wanchai Sattayawuthipong said during the weekend.
The recall is now underway and will conclude within the next 14 days. Recalled 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; and Valsarin 320 drug registration No 1A 6/60.
The first two drugs are manufactured by Silom Medical while the other three are by Unison Laboratories.
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.
“In Thailand, there are only two firms that have used valsartan from Zhejiang Huahai Pharmaceuticals,” FDA secretary-general Dr Wanchai Sattayawuthipong said recently.
‘These drugs must be destroyed’
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.”
Wanchai said Silom Medical and Unison Laboratories had been ordered to stop manufacturing drugs containing valsartan coming from the Chinese supplier.
“Urgent alerts have already been issued to all relevant authorities, too,” he said.
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.
A Thai-language community Facebook page “1412 Cardiology”, which is often used as an online source of useful medical information, has recommended Diovan, Co-Diovan, Tareg, Co-Tareg, Valpres, Exforge, Exforge-HCT, Dafiro, and Entresto brands.
Their ingredients are from European manufacturers and not from Zhejiang Huahai Pharmaceuticals.