The Ministry of Food and Drug Safety (MFDS) said Tuesday that it would restrict new approvals of amfepramone and mazindol, the two anorectic agents tantamount to psychotropic drugs among medical narcotics.
The restriction comes as public safety concerns are being raised about drug abuse because of increased adoption of appetite suppressants defying efforts to ensure proper use, the ministry said. About 1.28 million patients used anorectic agents from July 2019 to May 2020.
|The Ministry of Food and Drug Safety will restrict new approvals of amfepramone and mazindol, appetite suppressants frequently abused and misused as psychotic drugs. (MFDS)|
Other appetite suppressants, including phentermine and phendimetrazine, were designated as restricted ingredients in 2013.
The restricted anorectics are drugs containing amfepramone, mazindol, gamma-hydroxybutyrate (GHB), and the isomer and salts of isomers, phentermine, phendimetrazine, and propofol. The regulatory agency restricted the new approval of amfepramone and mazindol due to frequent misuses, such as confirmed cases of combined administration of different appetite suppressants and long term use.
The ministry restricted new approvals of GHB, a party drug or date rape drug, also known as liquid crystals, as people could use it for crimes.
Besides, some people considered the short-term weight loss adjuvants, phentermine and phendimetrazine, as a panacea for reducing weight, and have frequently misused or overuse them.
There have also been many cases of using propofol as medication for fatigue and sleeping pills, forcing regulators to restrict its new approvals.
However, new formulations or products for export can receive new approval regardless of this restriction, it noted.
The ministry said it explained the need to tighten up the control of these drugs at a meeting with industry officials and listened to their opinions before making the decision.
“We will continue to prevent drug misuse and abuse by promoting public relations activities and additional safety measures for experts to ensure their safe use and proper prescription of medical drugs,” a ministry official said.
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