Meridia (sibutramine) by Abbott risks heart disease in obese patients, says US FDA

Meridia, a drug to help patients lose weight, promoted by Abbott, may lead to heart disease, studies found.

Meridia, which contains sibutramine hydrochloride monohydrate risk hear, has higher risk of cardiovascular events experts suggest.

Meridia (sibutramine hydrochloride monohydrate) is currently being reviewed by US FDA to ascertain the possible risk of cardiac side-effects.

Preliminary data on Meridia (sibutramine hydrochloride monohydrate) suggest that patients taking the drug may have a higher risk of cardiovascular problems, US FDA said.

“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.

Abbott lauched a study to analyze the risk of cardiovascular-related problems of Meridia (sibutramine hydrochloride monohydrate) in 2003 at the request of European regulators.

Abbott’s Meridia (sibutramine hydrochloride monohydrate), study involved high-risk patients with a history of cardiovascular problems.

Meridia was not approved for 90 percent of patients in the study.

“Sibutramine is approved for patients who are obese and have no history of cardiovascular disease,” statedAbbott spokesman Kurt Ebenhoch.

Abbott is reviewing the data. However, Abbott did not believe in 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.

Tt 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, at that time.

Meridia is an appetite suppressant.Sibutramine produces its therapeutic effects by norepinephrine, serotonin and dopamine reuptake inhibition.

Sibutramine (Meridia’s) efficacy as a weight loss treatment was examined in 11 double-blind, placebo-controlled obesity trials with study durations of 12 to 52 weeks and doses ranging from 1 to 30 mg once daily.

Weight was significantly reduced in a dose-related manner in sibutramine-treated patients compared to placebo over the dose range of 5 to 20 mg once daily. In two 12-month
studies, maximal weight loss was achieved by 6 months and statistically significant weight loss was maintained over12 months.

Analysis of the data in three long-term obesity trials indicated that patients who lose at least 4 pounds in the first 4 weeks of therapy with a given dose of sibutramine are most likely to achieve significant long-term weight loss on that dose of sibutramine.

Approximately 60% of such patients went on to achieve a placebo-subtracted weight loss of  5% of their initial body weight by month 6. Conversely, of those patients on a given dose of sibutramine who did not lose at least 4 pounds in the first 4 weeks of therapy, approximately 80% did not go on to achieve a placebo-subtracted weight loss of 5% of their initial body weight on that dose by month 6.

Meridia can cause side effects ranging from headaches and constipation to higher blood pressure and a faster heart rate.