My office is investigating claims of injury because of this recalled product.
Sibutramine is a centrally-acting serotonin-norepinephrine reuptake inhibitor. Serotonin and norepinephrine reuptake inhibitors (SNRIs) are a type of antidepressant medication that increases the levels of both serotonin and norepinephrine by inhibiting their reabsorption (reuptake) into cells in the brain. Although the precise mechanism of action isn't clear, it's thought that these higher levels enhance neurotransmission — the sending of nerve impulses — and so improve and elevate mood. Medications in this group of antidepressants are sometimes called dual reuptake inhibitors.
Sibutramine was originally launched and marketed by Knoll Pharmaceuticals and was most recently manufactured and marketed by Abbott Laboratories before its withdrawal from the market.
This product should not be used by people with with:
- Psychiatric conditions
- Patients with a history of or a predisposition to drug or alcohol abuse
- Patients below 18 and above 65 years of age
- 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)
- Stroke or transient ischemic attack (TIA)
- Hyperthyroidism (overactive thyroid gland)
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.
Sibutramine may substantially increase blood pressure and pulse in some patients.
These 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.
