WASHINGTON, Nov 20 (Reuters) - U.S. 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 percent 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.
The FDA in 2005 rejected a consumer group's petition to remove Meridia from the market due to cardiovascular problems, deciding that the drug's benefits outweighed its risks when used appropriately to treat obesity.
The FDA said at that time that it was not possible to conclude Meridia caused the reported problems and that it had worked with Abbott to change the drug's labeling and to educate doctors about which patients can take the drug.
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.
(Reporting by Lisa Richwine and Deena Beasley; Editing by Carol Bishopric, Gary Hill) Keywords: ABBOTT MERIDIA/ (Reuters Messaging: lisa.richwine.reuters.com@reuters.net +1 202 310 5691) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
'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 percent 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.
The FDA in 2005 rejected a consumer group's petition to remove Meridia from the market due to cardiovascular problems, deciding that the drug's benefits outweighed its risks when used appropriately to treat obesity.
The FDA said at that time that it was not possible to conclude Meridia caused the reported problems and that it had worked with Abbott to change the drug's labeling and to educate doctors about which patients can take the drug.
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.
(Reporting by Lisa Richwine and Deena Beasley; Editing by Carol Bishopric, Gary Hill) Keywords: ABBOTT MERIDIA/ (Reuters Messaging: lisa.richwine.reuters.com@reuters.net +1 202 310 5691) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.