Korea bans local sales of Medytox’s BTX drug Meditoxin

Sales of the botulinum toxin product Meditoxin, from South Korean drugmaker Medytox, have been banned due to apprehensions about an unapproved ingredient, authorities said Friday.

The Ministry of Food and Drug Safety said it will indefinitely suspend the manufacturing, selling and use of Meditoxin, adding that it was canceling its approval for Meditoxin products containing doses of 2, 4 and 6 milliliters.

The ministry made the decision after the prosecution revealed the results of an investigation showing that Medytox had used an unapproved ingredient to produce the drug. The company is accused of acquiring export approval by fabricating data on the ingredient as well as the potency of the drug.

Also, Medytox manufactured and sold the products even though their contents failed to comply with the ministry’s standards, according to the prosecution.

Botulinum toxin -- which Allergan made famous when it introduced its trademarked Botox, widely used to reduce wrinkles -- is a toxic substance that paralyzes muscles by inhibiting neurotransmitters. Apart from cosmetic uses, it can also be used to treat eye twitches, muscle stiffness after a stroke and difficulty walking due to cerebral palsy.

Despite its decision to cancel its approval, the ministry said people who have already used the drug have little to worry about, as the doses are extremely small and the ingredient is easily broken down by enzymes in the body.

By Kim Byung-wook (kbw@heraldcorp.com)