http://www.straitstimes.com/BreakingNews/TechandScience/Story/STIStory_457337.html
WASHINGTON - US REGULATORS are reviewing preliminary data suggesting patients taking Abbott Laboratories Inc's weight loss drug Meridia may have a higher risk of cardiovascular problems, the Food and Drug Administration said on Friday.
'The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time,' the agency said in a statement.
The FDA said early findings from a recent study suggested patients taking Meridia, also known as sibutramine, may have a higher number of cardiovascular-related problems, including heart attacks, strokes, cardiac arrests and deaths, when compared to patients who took a placebo.
A spokesman for Abbott said the study, launched in 2003 at the request of European regulators, involved high-risk patients with a history of cardiovascular problems. 'Sibutramine is approved for patients who are obese and have no history of cardiovascular disease,' said Abbott spokesman Kurt Ebenhoch.
'Meridia is not approved for 90 per cent of patients in the study.' He said Abbott is reviewing the data, but does not believe that it indicates the need for a change in the safety profile of the drug when it is used in the approved patient population according to prescribing instructions.
Meridia is an appetite suppressant approved to treat obese adults. It can cause side effects ranging from headaches and constipation to higher blood pressure and a faster heart rate. -- REUTERS
Sat Nov 21, 2009 11:10 am