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Regulators to add liver damage risks to antiobestic drug
  • By Lee Hye-seon
  • Published 2017.08.01 17:21
  • Updated 2017.08.01 17:21
  • comments 0

Antiobestic drug Contrav ER Tab. (compound: naltrexon/bupropion), imported and sold by Kwang Dong Pharmaceutical광동제약, has reportedly damaged livers in Europe, prompting Korean regulators to add such cases to their internal approvals, officials said.

The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 said Thursday it would announce changed approvals on Contrav ER Tab. on its website, and accept opinions until Aug. 11.

The proposed change in approvals comes as a follow-up step to safety information distributed by European Commission.

According to the report from Europe, people who took naltrexone HCl (16~48mg), one of the main components of Contrav콘트라브 ER Tab., showed drug-induced liver injury (DILI) and an increase in liver enzyme levels in clinical trials. Accordingly, patients suspected of suffering liver damage after taking Contrav ER Tab have to stop intake

Contrav ER Tab. Has been developed as the composite therapy of bupropion effective to nicotine addiction, and naltrexon used for the treatment of alcoholism and drug addiction.

It has been known to keep a balance between food ingestion and energy metabolism and control food intake by working on the brain’s compensation neural circuit.

It is the antiobestic drug approved both in the U.S. and Europe and was released as Mysimba in Europe and Contrav ER Tab.(Contrave) in the U.S. and Korea.

The drug made a debut in the Korean market in June 2016 and caught attention as a new therapy to treat obesity, along with Belviq.

lhs@docdocdoc.co.kr

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