'Oxiracetam' shows no improvement in 'vascular cognitive impairment'... "Other medications should be used"

[Asia Economy Reporter Byeon Seon-jin] The Ministry of Food and Drug Safety announced on the 16th that it has distributed a drug information letter recommending the suspension of prescription and dispensing of 'Oxiracetam' formulations, which have not proven effectiveness in improving symptoms of vascular cognitive impairment, and the use of alternative medicines.

This measure follows a comprehensive evaluation based on the review by the Ministry of Food and Drug Safety and consultation with the Central Pharmaceutical Review Committee of clinical trial results recently submitted by pharmaceutical companies.

The Ministry had previously instructed pharmaceutical companies to re-evaluate the effectiveness of the approved indications of formulations containing this ingredient through domestic clinical trials at the latest scientific standards. Accordingly, pharmaceutical companies submitted the results of clinical trials conducted on the efficacy of Oxiracetam formulations for 'improving symptoms of vascular cognitive impairment,' but failed to prove the effectiveness of this product.

In the drug information letter, the Ministry requested cooperation from medical and pharmaceutical professionals to use alternative medicines for patients with 'vascular cognitive impairment.' Patients already taking formulations containing this ingredient were advised to consult with their doctors or pharmacists.

Additionally, cooperation was requested from the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to ensure that hospitals, clinics, and pharmacies exercise caution when prescribing and dispensing this product.

The Ministry explained that although there are no safety issues, the measure is a proactive step ahead of subsequent administrative procedures such as public viewing of the re-evaluation draft (20 days), objection period (10 days), and announcement of results (deletion of the relevant indication/effect).

The Ministry of Food and Drug Safety stated that it will continue to re-evaluate the safety and effectiveness of medicines at the latest scientific standards to ensure that the public can use medicines with confidence.