Taiwan recalls cold medicines over health concerns

台灣回收有健康疑慮的感冒藥

Medicines containing ingredient 'fenspiride' to be taken off shelves


TAIPEI (Taiwan News) — The health authorities in Taiwan announced on Wednesday (June 17) the removal of a dozen cold medicines from the marketplace over a potentially harmful ingredient.

Fenspiride (芬士比瑞), a compound used to treat respiratory diseases, including rhinitis, laryngitis, and bronchitis, has been found to be associated with adverse drug reactions (ADR), such as torsade de pointes and QT prolongation, according to the Taiwan Food and Drug Administration (FDA). The adverse reactions involve abnormal heart rhythms that when serious, could result in cardiac arrest.

The drug recall is a pre-emptive measure, as there have been no reports yet of serious fenspiride-induced ADR cases in Taiwan. However, the country has recorded two incidents involving heart palpitations in the past five years related to medications containing the compound, said Huang Chyn-liang (黃琴喨), a technical specialist at the FDA.

Given the risk of fenspiride's side effects and the adequate availability of alternatives, the FDA has decided to revoke 12 drug licenses and withdraw the medications. Import, manufacture, sale, and display of the relevant medications will be banned starting June 17, and an assessment of the drug's efficacy and risks will be conducted, noted Huang.

According to data from the National Health Insurance Administration, 446,355 people accessed capsules and tablets containing the compound in 2017, while 229 received injections. Most of the patients were treated at local clinics, wrote CNA.