Handok recalls part of the domestic supply of its antiepileptic treatment, Sabril Tab 500mg (vigabatrin), likely exacerbating the drug’s supply shortage.
According to the Ministry of Food and Drug Safety (MFDS), Handok has recalled some batches of Sabril 500 mg (manufacturing number SAFA001) since last Friday. Sabril is a treatment for epilepsy and infantile spasms developed by Sanofi and supplied by Handok with a domestic license.
Handok said that it got information from abroad that a tiny amount of “tiapride,” a different drug component, had been found in Sabril’s primary ingredient of vigabatrin. It added that the ongoing recall is a preventive marketing move by withdrawing the product batch using that component from the market.
Tiapride is the main ingredient of medicines used to treat neurological and psychiatric disorders, including movement disorders, neuromuscular pain, aggression, and agitation. There are no tiapride-based products approved in Korea.
Regarding why tiapride was found in vigabatrin, Handok presumed that an Italy-based manufacturer of vigabatrin might have produced it using the same facilities that had been used to make tiapride without knowing a fraction of tiapride remained in them.
The recall of the tiapride-containing vigabatrin is underway globally.
However, the highest detected level of tiapride is below the daily exposure limit of 200μg/day, and it is unlikely to cause adverse effects, according to Handok.
Sabril had caused supply problems before, running out of stock frequently. For instance, the Korea Children's Hospital Association held a news conference in June, announcing essential medicines for severe diseases with supply shortages, including Sabril.
At the press conference, Choi Yong-jae, vice chairman of the association, said, "Drugs needed to treat severe pediatric diseases have been out of stock for more than a year, making it impossible to make treatment decisions," calling for the government to take action.
The ministry ordered Handok to conduct a recall and distributed a drug safety letter to medical and pharmaceutical professionals.
It also urged users to check the manufacturing number and expiration date and exercise caution when using the drug, emphasizing the need to report immediately any abnormalities, such as the occurrence of side effects, to the Korea Institute of Drug Safety and Risk Management.