Weight-loss pill sibutramine (Meridia) may face ban in US

Weight loss drug sibutramine, which is being sold under the brand name Meridia by Abbott, could face ban in US.

Sibutramine (Meridia) is being used by roughly a quarter million people to lose weight in US. Backgrounder: Meridia (sibutramine) by Abbott risks heart disease in obese patients, says US FDA

Sibutramine (Meridia) can increase the risk of heart attack, stroke and death, in patients consuming the drug as an aid to shed their excess flab.

Preliminary results from a study involving 10,000 patients showed a slightly higher risk of heart-related problems in patients taking Meridia compared with a dummy pill.

The study group consisted patients older than 55, overweight with a history of heart disease or diabetes.

On the basis of this study, a consumer advocacy group Public Citizen has petitioned the government and the US Food and Drug Administration to ban the weight loss pill Meridia.

The only appropriate US FDA action to protect the public health was to immediate remove Meridia from the market since the science behind the results seen in this study would mandate nothing less than that, the petition said.

A total of 84 deaths were associated with Meridia as of June since US FDA approved the drug in 1997 as a weight loss aid together with diet and exercise.

However, US FDA was making no conclusions about the preliminary findings, the agancy clarified on release of the data last month.

US FDA’s panel of outside specialists voted out 5 to 4 for sibutramine (Meridia) as they found the drug’s risks outweighed its benefits, the Public Citizen group’s petition pointed out.

US FDA had rejected a similar petition from Public Citizen in 2005 seeking withdrawal of  Meridia, suggesting that wanted to wait for the findings of the 10,000-patient study.

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 review ing 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.

What is sibutramine?

Sibutramine is a centrally acting stimulant chemically related to amphetamines. Sibutramine is classified as a Schedule IV controlled substance in the United States. Sibutramine acts by increasing serotonin and norepinephrine levels in the brain.

Sibutramine’s serotonergic action is thought to influence appetite.

Sibutramine is a neurotransmitter reuptake inhibitor that helps enhance satiety by inhibiting the reuptake of serotonin (by 53%), norepinephrine (by 54%), and dopamine (by 16%).

Sibutramine may cause side effects including: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, anorgasmia and delayed ejaculation, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.

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