About

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Sibutramine, formerly sold under the brand name Meridia among others, is an appetite suppressant which has been discontinued in many countries. Until 2010, it was widely marketed and prescribed as an adjunct in the treatment of obesity along with diet and exercise. It has been associated with increased cardiovascular events and strokes and has been withdrawn from the market in several countries and regions including Australia,^[1] Canada,^[2] China,^[3] the European Union,^[4] Hong Kong,^[5] India,^[6] Mexico, New Zealand,^[7] the Philippines,^[8] Thailand,^[9] the United Kingdom,^[10] and the United States.^[11] However, the drug remains available in some countries.^[12]

Sibutramine was originally developed in 1988 by Boots in Nottingham, UK,^[13] and marketed by Knoll Pharmaceuticals after BASF/Knoll AG purchased the Boots Research Division in 1995, and was most recently manufactured and marketed by Abbott Laboratories before its withdrawal from most markets. It has been sold under a variety of brand names including Reductil, Meridia, Siredia, and Sibutrex. It is classified as a Schedule IV controlled substance in the United States.

Medical uses

Sibutramine has been used to produce appetite suppression for the purpose of attaining weight loss in the treatment of patients with obesity.

Contraindications

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Sibutramine is contraindicated in patients with:

• Psychiatric conditions as bulimia nervosa, anorexia nervosa, serious depression or pre-existing mania
• Patients with a history of or a predisposition to drug or alcohol abuse
• Hypersensitivity to the drug or any of the inactive ingredients
• Patients below 18 and above 65 years of age^[14]
• Concomitant treatment with a MAO inhibitor, antidepressant or other centrally active drugs, particularly other anoretics
• History of peripheral arterial disease
• Hypertension that is not sufficiently controlled (e.g., >145/90 mmHg), caution in controlled hypertension
• Existing pulmonary hypertension
• Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction
• A history of coronary artery disease (e.g., angina, history of myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack (TIA))^[14]
• Stroke or transient ischemic attack (TIA)
• Hyperthyroidism (overactive thyroid gland)
• Closed angle glaucoma
• Seizure disorders
• Enlargement of the prostate gland with urinary retention (relative contraindication)
• Pheochromocytoma
• Pregnant and lactating women (relative contraindication)

Side effects

A higher number of cardiovascular events has been observed in people taking sibutramine versus control (11.4% vs. 10.0%).^[15] In 2010 the FDA noted the concerns that sibutramine increases the risk of heart attacks and strokes in patients with a history of cardiovascular disease.^[15]

Frequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.

In a 2016 Cochrane review sibutramine was found to substantially increase blood pressure and heart rate in some patients, in the updated review in 2021 sibutramine was not included since the drug had been withdrawn from the market.^[16] When used, regular blood pressure monitoring needed to be performed.

The following side effects are infrequent but serious and require immediate medical attention: cardiac arrhythmias, paresthesia, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).

Symptoms that require urgent medical attention are seizures, problems urinating, abnormal bruising or bleeding, melena, hematemesis, jaundice, fever and rigors, chest pain, hemiplegia, abnormal vision, dyspnea and edema.

Currently, no case of pulmonary hypertension has been noted. (Fenfluramine, of the 1990s “Fen-Phen” combo, forced excess release of neurotransmitters—a different action. Phentermine was uninvolved in the rare—but clinically significant—heart issues of fenfluramine.)