Other safety alerts
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| Update on worldwide action on Sibutramine |
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Situation in the United States
U.S. Food and Drug Administration announced that Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke. The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular OUTcomes trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.
Situation in Australia
Following discussions with the Therapeutic Goods Administration (TGA), Abbott Australasia will cease supply of sibutramine (Reductil) in Australia from 9 October 2010. Sibutramine, marketed in Australia as Reductil, is a prescription medicine indicated for weight loss.
Situation in Canada
Health Canada informs healthcare practitioners and Canadians that Abbott Laboratories is voluntarily withdrawing the prescription weight-loss drug sibutramine, which is marketed under the brand name Meridia®, from the Canadian market. The decision comes in light of data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, a large study that suggested an increased risk of serious cardiovascular events associated with sibutramine use in patients with heart problems.
Situation in Singapore
Health Sciences Authority informed that it has consulted with experts from its Pharmacovigilance Advisory Committee. Deliberations have taken into consideration the findings from the Sibutramine Cardiovascular OUTcomes (SCOUT) study, the use of the product locally, and developments in other international jurisdictions. A regulatory decision will be announced upon completion of the review.
Situation in Hong Kong
Press release regarding Abbott Lab Ltd’s withdrawal of the registration of Reductil and its generic version Sibutil (both containing sibutramine) in Hong Kong and recall the products from local shelves was issued on 8 October 2010. Letters to inform healthcare professionals about this issue were also issued on the same day. There are 49 other generic products containing sibutramine registered in Hong Kong. The Registration Committee of the Pharmacy and Poisons Board will discuss the updated results of the SCOUT study in the coming meeting.
Please refer to the following websites for details:
1. Food and Drug Administration, the United States
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm228812.htm
2. Therapeutic Goods Administration, Australia
http://www.tga.gov.au/alerts/medicines/reductil-withdrawal.htm
3. Health Canada, Canada
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_169-eng.php
4. Health Sciences Authority, Singapore
http://www.hsa.gov.sg/publish/hsaportal/en/news_events/hsa_updates/2010/hsa_reviews_benefit-risk.html
Ends/Monday, October 11, 2010
Issued at HKT 14:30
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