The drug regulator is taking steps to revoke the indication of acetyl-L-carnitine, a cognitive function enhancer.
On Friday, the Ministry of Food and Drug Safety suspended the prescription and dispensing of acetyl-L-carnitine-containing medicines and recommended using alternative drugs.
Earlier, the MFDS requested acetyl-L-carnitine manufacturers to conduct local clinical trials of the drug and submit trial results. Upon the request, companies tested acetyl-L-carnitine to prove its effect against “a secondary degenerative disease after a cerebrovascular disease” and submitted the outcomes.
However, acetyl-L-carnitine failed to prove its efficacy in that indication, the MFDS said. After reviewing the clinical results and the Central Pharmaceutical Affairs Council’s advice, the MFDS concluded that the treatment had no safety issues but failed to prove effectiveness.
The MFDS said it would allow acetyl-L-carnitine manufacturers to check the latest re-evaluation results, designate a period for objections, and publicize the agent’s efficacy/effectiveness deletion.
In June 2016, the MFDS deleted acetyl-L-carnitine’s indication for “a primary degenerative disease after a cerebrovascular disease” due to its failure to prove the efficacy during the drug re-evaluation.
In a statement to patients, the MFDS said those taking acetyl-L-carnitine should consult with a doctor or a pharmacist.
“We will review the need for the drug’s additional safety measures and promptly take actions putting the highest priority on public safety,” the MFDS said. “We request medical and pharmaceutical professionals to pay attention to the drug’s latest information and provide guidance on prescription, administration, and medication.”
Thirty-five Korean drug companies make acetyl-L-carnitine medicines, including Hanmi Pharmaceutical and Dong-A Pharmaceutical.