Food and drug agency under fire over diet pill

By Bae Ji-sook

The Korea Food and Drug Administration (KFDA), headed by Noh Yun-hong, is coming under criticism for its lax management of controversial sibutramine-based drugs used for weight loss, which have recently been banned from the U.S. and European markets.

The KFDA, which reapproved its safety and distribution in July, Saturday announced a plan to review the substance once again after much criticism arose regarding lax monitoring. The meeting will decide whether Korea will also shelve the drug.

Sibutramine is an orally administered appetite suppressant for the treatment of obesity. It is manufactured and marketed by Abbott Laboratories, under brand names such as Reductil, Meridia and Sibutrex. In Korea, 56 products using the chemical from 38 companies including Abbott’s Reductil are sold.

Sibutramine has been associated with increased cardiovascular disease and strokes and has been ordered withdrawn from use in the U.S., U.K., EU and Australia.

“The FDA requested this withdrawal after concluding that the continued availability of this product is not justified since patients taking the drug are at an increased risk of suffering a heart attack or stroke,” John Jenkins, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, was quoted as saying at a press conference by media outlets. Besides finding an increased risk of heart attack and stroke, the review trial found only a small difference in weight loss among those taking the drug and those receiving a placebo, he said.

The agency advised doctors to stop prescribing Meridia (Abbott’s U.S. sibutramine product) to their patients, pharmacists to stop dispensing it, and patients to stop taking the drug, while disposing of any remaining products.

However, the Korean FDA’s moves were less than impressive during the same period. In July, it reauthorized the sales of Reductil and other sibutraimine-based drugs saying under the strict monitoring of doctors, the drugs seemed safe. It was only after the slew of other countries’ announcement of countermeasures that the authorities stepped in to make a revision.

“It seems that all the KFDA is worried about is following other countries’ guidelines instead of setting up its own investigation into such drugs. Though sibutramine has been an issue for a long time, the Korean government has done nothing but wait and see what others were doing. We aren’t even sure what the exact health damage Korean customers would suffer,” said Kang Ah-ra, spokeswoman for the Korean Pharmacists for a Democratic Society.

Abbott decided to make a voluntary recall of Meridia, but its Korean branch has yet to make any decision about a recall.

Regardless of the authorities’ decision, the safety issue of the slimming pills began to grab the attention of consumers. According to industry insiders, the sales of weight loss pills slid 10 percent within a year, after the safety issue dealt a huge blow last year. The market’s revenue reached 101.1 billion won last year, a huge jump from 60.3 billion won in 2006, but fell to 20.01 billion won in the first quarter of the year and is expected to remain sluggish for the rest of the year.

식약청이 최근 비만치료제인 시부트라민의 사용제제를 놓고 애매한 태도를 보이고 있어 비난의 대상이 되고 있다.

식약청은 미국과 유럽의 식약청이 성분의 사용중지결정을 내린 후에야, 이에 대해 재검토를 하기로 했다.

식약청은 지난 7월 시부트라민의 사용에 대해 다시 한 번 사용허가를 했으며 안정성을 인정했다. 그러나 지난 9일 미국 등지의 소식이 전해진 후 여론의 비난을 듣게 되자 다시 사용검토를 하겠다고 밝혔다.

따라서 심의회에서 다시 한 번 시부트라민의 사용 향방이 갈릴 것으로 예상된다.

시부트라민은 식욕억제재로 비만치료에 사용된다. 애보트사에서 현재 생산, 관리되고 있으며 리덕틸, 매리디아 등의 이름으로 판매되고 있다. 한국에서는 판매명은 리덕틸이다.