Diet Drugs Containing Sibutramin Prohibited

Food and Drugs Supervisory Agency, cancel and withdraw the marketing authorization of drugs that contain sibutramine which there are many on drugs decrease overweight or diet drug.

In a press release, POM states, withdrawal of drugs containing sibutramine be conducted from 14 October. This is a follow-up of the information security aspects of drug product obtained by the study results "Sibutramine on Cardiovascular Outcomes Triaf" (SCOUT), which showed an increased risk of cardiovascular events.

Also, sibutramine has also been banned from some authority in other countries on the basis of updated information on safety aspects of long-term use of sibutramine SCOUT study results, which showed an increased risk of incident kadiovaskular in patients with a history of cardiovascular disease.

"With this latest information security aspects, in order to protect the safety and public health, POM RI has conducted the cancellation and withdrawal of marketing authorization of drug products containing sibutramine starting on 14 October," said Chief BPOM Kustantinah.
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