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NorMeiTing and Similar Weight-Loss Drugs Recalled Nationwide
pine Webmaster of Pineapple
2010/10/12 14:12
508 topics published
【United Daily News╱Reporters Liu Huimin and International News Group】2010.10.11
The weight-loss drug Reductil (sibutramine), which has been on the market in Taiwan for eight years with a high market share, will be withdrawn due to its increased risk of severe heart disease. Following similar actions by the EU, the U.S., Canada, and other countries, Taiwan’s Department of Health has decided to follow suit. Starting tomorrow, Reductil and other weight-loss drugs containing the same active ingredient will be completely pulled from the market, and pharmaceutical companies will have one month to recall all products currently on sale.
Abbott Laboratories, the manufacturer of Reductil, stated that it will comply with the decision. Hsü Chien-wen, deputy director of the Drug Division at the Taiwan Food and Drug Administration (TFDA), advised those currently taking Reductil to consult their prescribing physicians as soon as possible to adjust their medication or seek alternative treatments. Consumers concerned about the risks may also request refunds.
Studies have shown that long-term use of weight-loss drugs containing sibutramine, such as Reductil, may increase the risk of cardiovascular diseases. Earlier this year, the EU recommended that member states withdraw these drugs from the market. On October 8, Australia, the U.S., and Canada also announced their removal. The U.S. Food and Drug Administration (FDA) noted that sibutramine, the key ingredient in Reductil, is a stimulant that may cause hypertension, stroke, or heart problems in some consumers.
After receiving the news late on October 9, the Department of Health deliberated overnight and decided to follow the international trend. Hsü Chien-wen stated that Taiwan has approved 15 weight-loss drug licenses containing sibutramine. In addition to the well-known Reductil, nine other brands—including Meishan Ailixian, Leshaozhi, Qingting, Nuoyu, Kaka, and Shiquan Xiti Capsules—also contain this ingredient and must be withdrawn simultaneously.
Domestic statistics show that since Reductil’s launch, 302 adverse reaction reports related to sibutramine-containing drugs have been filed, with 115 cases linked to cardiovascular diseases. In just the past month alone, 16 new adverse reaction cases involving cardiovascular issues were reported. However, Hsü noted that no severe or fatal cases have been identified in Taiwan so far.
The Department of Health announced that starting tomorrow, medical institutions, pharmaceutical companies, and pharmacies must immediately cease importing, manufacturing, dispensing, or retailing Reductil and related products. Companies have one month to recall all products on the market. Violators may face fines ranging from NT$20,000 to NT$100,000 under the Pharmaceutical Affairs Act.
Source:
http://udn. com/ NEWS/ HEALTH/ HEA1/ 5900749. shtml