Meridia Safety

In placebo-controlled studies:

• Rate of withdrawal due to all adverse events was comparable to placebo at 9% (n=2,068, MERIDIA) vs 7% (n=884, placebo)
• Rate of withdrawal due to hypertension was 0.4% for MERIDIA vs 0.4% for placebo
• MERIDIA once daily was associated with mean increases in systolic and diastolic blood pressure of approximately 1 mmHg to 3 mmHg relative to placebo
• Can be used with clinical supervision in controlled hypertensive patients. For patients who experience a sustained increase in blood pressure or pulse rate while receiving MERIDIA, either dose reduction or discontinuation should be considered
• Most common adverse events were mild to moderate and transient, and included headache (30%), dry mouth (17%), anorexia (13%), constipation (12%), and insomnia (11%)
• The safety and efficacy of MERIDIA have not been determined beyond 2 years at this time

ADDITIONAL SAFETY INFORMATION

IMPORTANT CONSIDERATIONS FOR MERIDIA

Because MERIDIA inhibits serotonin reuptake, in general, it should not be administered with other serotonergic agents. However, if such a combination is clinically indicated, appropriate observation of the patient is warranted.

MERIDIA is a controlled substance in Schedule IV.

MERIDIA is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs), who have anorexia nervosa, who have hypersensitivity to sibutramine or any of the inactive ingredients of MERIDIA, and those taking other centrally acting appetite-suppressant drugs.

MERIDIA substantially increases blood pressure in some patients. Regular monitoring of blood pressure is required when prescribing MERIDIA.

MERIDIA should not be used in patients with a history of coronary artery disease, arrhythmias, congestive heart failure, or stroke. MERIDIA should not be used in patients with uncontrolled or poorly controlled hypertension, severe hepatic dysfunction, or severe renal impairment. MERIDIA should be used with caution in patients with narrow-angle glaucoma or a history of seizures.

Current Safety Topics in the News

You may have heard MERIDIA mentioned in the news recently. Abbott Laboratories would like to assure you of the safety, effectiveness and continued availability of MERIDIA in the United States.

In early March 2002, the Ministry of Health in Italy temporarily suspended sales of Reductil® (sibutramine, brand available in Italy) based on 2 reports of death in Italy. Abbott Laboratories’ thorough review of these reports indicated that both patients had other complicating conditions and had been taking other medications. While any death is a tragedy, there is no established link between the cause of these deaths and MERIDIA. Based on Abbott’s worldwide safety analysis and clinical trial experience of MERIDIA, the evidence does not point to an increased risk of death in patients taking MERIDIA.

In June 2002, after completing a comprehensive assessment of sibutramine, Europe’s Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion reaffirming the favorable risk/benefit profile of sibutramine. The positive opinion was supported by an extensive analysis of data that included more than 100 clinical trials involving more than 12,000 obese patients. We are fully confident in the safety and effectiveness of MERIDIA.

Since it was first approved in 1997, more than 8.5 million people in more than 70 countries have used MERIDIA for the management of obesity. MERIDIA is the most extensively studied prescription medication for obesity and was determined to be safe and effective by the FDA.

For Abbott’s response to the Public Citizen’s petition submitted March 19, 2002, to the FDA regarding MERIDIA click here.