No more approval on all appetite suppressants

Concerns of abusing narcotics for medical purpose raised, amfepramone and mazindol newly added on restricted approval list

New approval on appetite suppressant amfepramone, also known as diethylpropion hydrochloride, and mazindol drugs would be restricted.

 

These substances were added to the list of restricted approval substance due to the risk of abusing narcotics for medical purposes.

 

Now, the list of restricted narcotic drugs includes amfepramone, mazindol, GHB, phentermine, phendimetrazine and propofol.

 

On Aug.

 

14, South Korea’s Ministry of Food and Drug Safety (MFDS) announced appetite suppressant amfepramone and mazindol would be designated as narcotics for medical purpose (psychotropic drug) ad restricted from new approval.

 

Currently, 14 amfepramone items and two mazindol items are approved and available in the market.

 

The ministry explained the restriction has been ordered to protect the safety of the people as concerns of abusing these drugs have been raised, regardless of the effort made so far to promote the adequate use of appetite suppressants.

 

The production volume of appetite suppressants have increased from 244,213 in 2017 to 283,042 in 2019.

 

Also 128 users have been reported for using the products from July last year through last May.

 

Other appetite suppressants like phentermine and phendimetrazine have been restricted from new approval since 2013.

 

With the new action, MFDS stated all appetite suppressants would be restricted from new approval.

 

However, a product in new formulation or for export purpose would be able to seek for approval, regardless of the new restriction.

 

Prior to the action, MFDS noted the government has explained the need of tightened control over these drugs through industry meetings and opinion survey.

 

MFDS official said, “For the safe use and appropriate prescription of narcotics for medical purposes, the government would draw up plans to raise awareness of safe use of narcotics among the public and medical professionals.

 

And by cooperating with relevant institutes and companies, the ministry would do the best to prevent any harm caused by abusing narcotics for medical purpose.”