Taiwan FDA recalls tainted sartan blood pressure medicine by Sanofi

Three types of sartan high blood pressure medicine produced by French pharmaceutical maker Sanofi were ordered on Monday to be recalled after being found to contain a potential carcinogen, according to Taiwan’s Food and Drug Administration (FDA).

In a statement, the FDA said the three types of sartan medicines have been found to contain a type of impurity known as azidomethyl-biphenyl-tetrazole (AZBT), a chemical compound that can form during the manufacturing process of the active ingredient in some sartan medicines.

Sartans, which are also called angiotensin II receptor blockers, are medicines used to treat high blood pressure.

The three recalled Sanofi medicines pertain to the Aprovel Tab 150mg film-coated tablets, the Aprovel Tab 300mg film-coated tablets and the Coaprovel 300mg/12.5mg film-coated tablets, the FDA said.

A total of roughly 9.14 million tablets of these medicines must be fully withdrawn from the market by Nov. 26, FDA official Shirley Pan (???) told CNA.

They are commonly prescribed to patients suffering from high blood pressure, Pan said, indicating that these three medicine types are currently covered by the National Health Insurance (NHI) program.

More than 38 million of these tablets were consumed in Taiwan last year, Pan said, citing NHI data.

She advised patients currently taking any of the sartan medicines to consult a doctor and discuss alternatives.

Source: Focus Taiwan News Channel