The Ministry of Food and Drug Safety (MFDS) has refuted criticism that patients suffer due to its hasty recall of an epilepsy drug.

In a news release on Tuesday, the ministry said it was aware of the shortage of Sanofi's epilepsy and infantile spasms drug Sabril (vigabatrin) and would supply a large amount of the drug in Korea this month.

The ministry refuted the criticism that it had caused a supply shortage by recalling Sabril tablets without securing an alternative drug. Last Friday, the ministry ordered Handok, the domestic licensee of Sabril, to recall the batch of Sabril with specific manufacturing numbers.

The ministry said it had been aware of the shortage in advance and planned to supply it quickly this month through discussions with the medical community and manufacturers. According to the ministry, the recent recall of some Sabril tablets was made amid such a situation and would not have a significant impact.

"To carefully grasp the demand and supply status of the drug in the medical field, we have made various efforts by, for instance, holding a meeting with the Korean Children’s Hospital Association on June 27, listening to experts’ advice, and having industrial consultation,” the ministry said. “We also encouraged Handok, the domestic manufacturer, to supply Sabril tablets quickly."

The ministry noted that Handok decided to import 980,000 tablets of Sabril in bulk tablets this month instead of the originally scheduled December, which will likely pass customs clearance on Friday. The ministry added that it is equivalent to a five-month supply, and Handok also has 92,000 Sabril tablets not subject to recall.

"While we were taking these measures, we received overseas information that tiny amounts of tiapride, a main ingredient of other medicines, were detected in some of the vigabatrin used in Sabril tablets," the ministry said. "Although the likelihood of adverse effects is low, we recommended that the manufacturer proceed with the recall as a precautionary measure, considering that the safety of the detected ingredient has not been established for children."

The ministry does not plan to conduct a separate risk assessment for detecting tiapride in the active ingredient vigabatrin in Sabril tablets. Tiapride is the main ingredient of medicines used to treat neurological and psychiatric disorders, such as movement disorders, neuromuscular pain, aggression, and agitation.

"We have no plans for an investigation," the official added.