Keywords: EMEA, Sibutramine, Obesity, FDA, Merdia, Abbott
EMEA starts sibutramine review, as FDA investigates Meridia
Article | 23 November 2009
The European Medicines Agency (EMEA) says it has started a review of sibutramine-containing anti-obesity medicines (marketed in Europe under trade names such as Reductil, Zelium, Reduxade), because preliminary data suggest a possible increased risk of serious cardiovascular events. The decision to do so came at the agency’s November 16-19 meetings, which also saw decisions on a number of other drugs, reported separately today. under the heading of “Meeting highlights.”
The data raising the concern about the anti-obesity drug come from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which investigated long-term cardiovascular effects of sibutramine treatment in a population with high cardiovascular risk. Enjoying this article? To continue reading you need to login, take a FREE trial or subscribe.
FREE unlimited, no obligation access to The Pharma Letter website for 30 days, normally worth £60!
Sign up in less than 60 seconds...no payment needed
Want to read the full article?
Take a 30 day FREE Trial worth £60
Take a no obligations 30 day trial.
Only one trial per user. Find out more details
Subscribe now
for unlimited access to all articles
Subscriptions are £60 per month, pay as you go.
Find out more details.
Already a subscriber? Click here to log in
- Pfizer acts to stop Mylan marketing generic Chantix; Allergan in $600 million settlement over Botox marketing practices
- PDL BioPharma sues Roche’s Genentech over royalties
- Novartis/NIH-sponsored research yields promising malaria drug candidate
- Indian’s Ranbaxy inaugurates new $30 million drug manufacturing facility in South Africa
- Seattle Genetics gets milestone as Astellas unit moves cancer drug into Ph I
