U.S. Brand Names: Meridia
Use: Sibutramine works to suppress the appetite primarily by inhibiting the reuptake of the neurotransmitters norepinephrine and serotonin. The Food and Drug Administration has approved sibutramine (Meridia) to aid weight loss only in people with significant obesity. It's not for simply shedding a few pounds, FDA guidelines say that the drug should be considered only for people with a body mass index of 30 or higher, or for those with a BMI of 27 or greater AND other conditions (such as obstructive sleep apnea and diabetes) which may improve with weight loss.
Pregnancy and Lactation: Not recommended when pregnant or nursing, unsure if drug is excreted in breast milk.
Contraindications: Do not use with MAOI's, allow at least a 2 week interval between stopping MAOI's and beginning Meridia and vice versa. Don't use if have a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Can cause mydriasis, use with caution if have narrow angle glaucoma.
Don't use if have hypersensitivity to sibutramine or any of its inactive ingredients. Don't use if have anorexia nervosa. Don't use if taking other centrally acting appetite suppresant drugs. Don't use if have severe renal impairment or severe hepatic dysfunction
Warnings/Precautions: Meridia substantially increases blood pressure in some patients. Regular monitoring of blood pressure is required when prescribing Meridia. Certain centrally acting weight loss agents that cause the release of serotonin from nerve terminals have been associated with pulmonary hypertension, a rare but lethal disease. Use with caution if have history of seizures, discontinue if have a seizure. Weight loss can equal gallstones. May interfer with judgement, thinking, or motor skills
Drug Interactions: Don't use with MAOI's, or with other serotonergic agents, use caution with drugs that raise the blood pressure or heart rate, don't use with alcohol.
1% to 10% experience:
GENERAL: Headaches, back pain, flu syndrome, injury accident, asthenia, abdominal pain, chest pain, neck pain, allergic reaction
CARDIOVASCULAR: Tachydardia, vasodilation, migrane, hypertension/increased blood pressure, palpitation
DIGESTIVE: Anorexia, constipation, increased appetite, nausea, dyspepsia, gastritis, vomiting, rectal disorder
METABOLIC AND NUTRITIONAL: Thirst, generalized edema
MUSCULOSKELETAL: Arthralgia, myalgia, tenosynovitis, joint disorder
NERVOUS SYSTEM: Dry mouth, insomnia, dizziness, nervousness, anxiety, depression, paresthesia, somnolence, CNS simulation
RESPIRATORY: Rhinitis, pharyngitis, sinusitis, cough increase, laryngitis
SKIN: Rash, sweating, herpes simplex, acne
SENSES: Taste perversion, ear disorder, ear pain
UROGENITAL: Dysmenorrhea, urinary tract infection, vaginal monilia, metrorrhagia
Less than 1% experience:
DIGESTIVE: Diarrhea, flatulence, gastroenteritis, tooth disorder
METABOLIC AND NUTRITIONAL: Peripheral edema
NERVOUS SYSTYEM: Agitation, leg cramps, hypertonia, thinking abnormal
RESPIRATORY: Bronchitis, dyspnea
UROGENITAL: Menstrual disorders
Other Notable Adverse Events:
Seizures experienced by less than .1% of patients, Ecchymosis bleeding disorders in .7% of patients, and interstitial nephritis.
U.S. Brand Names: Xenical
Use: Xenical is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. Xenical is indicated for obesity managment including weight loss and weight maintenance when used in cojunction with a reduced-calorie diet. Xenical is also indicated to reduce the risk for weight regain after prior weight loss. Xenical is indicated for obese patients with an initial body index (BMI) 30kg/m2 or 27kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).
Pregnancy and Lactation: Xenical is not recommended for use during pregnancy. It is not known if Xenical is secreted in human milk, so nursing women should not take Xenical while lactating.
Contraindications: Patients with chronic malabsorption syndrome or cholestasis should not use Xenical. Patients with known hypersensitivity to Xenical or to any component of this product should not use Xenical.
Warnings/Precautions: Patients should take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition since Xenical can reduce the absorption of some fat-soluble vitamins and beta-carotene. Take the supplement at least 2 hours before or after taking Xenical. Some patients may develop increased levels of urinary oxalate; use caution when prescribing Xenical to patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis. Weight loss induction be Xenical may be accompanied by improved metabolic control in diabetics, which might required a reduction in dose of oral hypoglycemia medication or insulin.
Less than 2% experienced:
GASTOINTESTINAL: Gastrointestinal events such as oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation, fecal incontinence may increase when Xenical is taken with a diet high in fat. Abdominal pain/discomfort, nausea, infectious diarrhea, rectal pain/discomfort, tooth disorder, gingival disorder, vomiting may also occur.
RESPIRATORY: Influenza, upper respiratory infection, lower respiratory infection, ear, nose, and throat symptoms
MUSCULOSKELETAL: Back pain, pain in the lower extremities, arthritis, myalgia, joint disorder, tendonitis
NERVOUS SYSYTEM: Headache, dizziness
GENERAL: Fatigue, sleep disorder
FEMEAL REPRODUCTIVE: Menstrual irregularity, vaginitis
URINARY: Urinary tract infection
PSYCHIATRIC DISORDER: Psychiatric Anxiety, Depression
HEARING AND VESTIBULAR DISORDERS: Otitis
CARDIVASCULAR: Pedal edema
U.S. Brand Names: Redux
Reason for Withdrawal from the Market: The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has asked the manufacturers to voluntarily withdraw both treatments for obesity from the market.
The action is based on new findings from doctors who have evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results.
The FDA recommends that patients using either of these products stop taking them. Users of these two products should contact their doctors to discuss their treatment.
These new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA's two earlier warnings concerning "fen-phen," a combination of fenfluramine and phentermine. "Fen-phen" has been widely used off-label in recent years for the long-term management of obesity.
Use: Redux, an anti-obesity durg, is a serotonin reuptake inhibitor and releasing agent. The action of Redux in treating obesity is primarily via decreased caloric intake associated with increased serotonin levels in brain synapses. Defenfluramine treatment in conjunction with a reduced-calorie diet is associated with a reduction in appetite and may slow gastric emptying.
Dexfenfluramine is indicated for the management of obesity including weight loss and maintenance of weight loss in patients on a reduced calorie diet. Dexfenfluramine is recommended for obese patients with an initial b.d. mass index greater than 30 kg/m2 or greater than 27 kg/m2 in the presence of other risk factors.
Pregnancy and Lactation: Not recommened in pregnant women. Not known if excreted in human milk, do not use if lactating.
Drug Interactions: In patients with MAOI's in combination with serotoninergic agents there have been reports of serious, sometimes fatal reactions. Caution is advised when using dexfenfluramine with other CNS-active drugs.
Contraindications: Patients with diagnosed pulmonary hypertension, patients receiving MOAI's inhibitors, patients with a hypersensitivity to dexfenfluramine, fenfluramine, or related compounds should not us this product. Don't use with alcohol as dexfenfluramine causes drowsiness. Do not use in conjunction with other weight loss drugs.
5% to 10% experienced:
Risk of primary pulmonary hypertension,diarrhea, dry mouth, somnolence, asthenia, insomnia, headache, depression.
5% or less experienced:
GENERAL: Anaphylaxis, congenital anomaly, eventration, hypothermia, laryngeal edema, peritonitis, reaction aggravation, retroperitoneal fibrosis, scleroderma, sudden death, infection, flu syndrome, pain, back pain, fever, allergic reaction, malaise, neck pain, chest pain, generalized edema, stress, face edema, neoplasm, pelvic pain, adenoma, immune system disorder, neck rigidity, suicide attempt
CARDIOVASCULAR: Pulmonary hypertension, atrial fibrillation, cardiomyopathy, cerebral vasculitis, ECG abnormal, heart arrest, heart failure, myocardial infarction, myocarditis, shock, tachycardia, ventricular fibrillation, ventricular tachycardia, hypertension, angine pectoris, palpitation, vasodilation, migrane, cardiovascular disorder, tachycardia, postural hyoptension, hypotension, peripheral vascular disorder, syncope, arrhythmia, extraystoles, hemorrhage, thrombophelebitis, varicose vein, heart block, pulmonary embolus, thrombosis
DIGESTIVE: Dysphagia, gastrointestinal disorder, tongue disorder
ENDOCRINE: Diabetic coma
GASTROINTESTINAL: Hepatic failure, jaundice, liver damage, constipation, nausea, dyspepsia, increased appetite, rectal disorder, gastritis, gastroenteritis, flatulence, colitis, eructation, gastrointestinal hemorrhage, enteritis, peptic ulcer, hepatitis, hepatomegaly, appendicitis, cholelithiasis, fecal incontinence, melena, mouth ulceration, pancreatitis, rectal hemorrhage, sialoadenitis
ENDOCRINE: Goiter, diabetes mellitus, thyroid disorder, hypothyroidism
HEMIC AND LYMPHATIC SYSTEM: Agranulocytosis, antinuclear antibody present, bone marrow depression, ecchymosis, hemolytic anemia, pancytopenia, anemia, lymphedema, coagulation disorder, lymphadenopathy, polycythemia, thrombocythemia
METABOLIC AND NUTRITIONAL: Dehydration, elevated lipases, increased prolactin, thyroid disease weight increase, edema, gout, hypoglycemia, hyopkalemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia
MUSCULOSKELETAL: Myopathy, arthralgia, myalgia, arthritis, leg cramps, joint disorder, tenosynovitis, myasthenia, rheumatoid arthritis, bursitis, tetany
NERVOUS: Antisocial reaction, apathy, cerebellar ataxia, cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, cerebral ischemia and cochlear infarction), choreoathetosis, convulsions, decreased reflexes, delirium, drug dependence, dyslexia, encephalopathy, grand mal convulsions, Guillain-Barre syndrome, hemiplegia,
hypoesthesia, manic-depressive psychosis, mania reaction, memory loss, meningism, meningitis, neuropathy, papilledema, paraplegia, personality disorder, reflexes increased, retrobulbar neuritis, schizophrenic reaction, stupor, subdural hematoma, twitch, withdrawal syndrome
nervousness, anxiety, increased libido, hypertonia, paresthesia, tremor, amnesia, euphoria, decreased libido, incoordination, neuralgia, speech disorder, ataxia, hyopkinesia, sleep disorder, abnormal gait, agitation, confusion, depersonalization, diplopia, hostility, hyperesthesia, hyperkinesia, peripheral neuritis
RESPIRATORY: Rhinitis, sinusitis, asthma, dyspnea, epistaxis, laryngitis, apnea, hyperventilation, pulmonary hypertenion, diffuse interstitial pneumonitis, dyspnea, hiccup, lung edema
SKIN: Sweating, alopecia, urticaria, pruritus, skin disorder, fungal dermatitis, hirsutism, eczema, psoriasis, skin hypertrophy
angioedema, bullous eruption, erythema multiforme, lower extremity purpura, purpura annularis telangiesctodes, Stevens-Johnson syndrome
SPEICAL SENSES: Taste perversion, amblyopia, abnormal vision, conjunctivitis, eye disorder, glaucoma, tinnitus, vestibular disorder, dry eyes, mydriasis, abnormality of accommodation, anisocoria, lacrimation disorder, miosis, parosmia, retinal disorder ophthalmoplegia, photophobia, transitory deafness, visual field defects
UROGENITAL: Menstrual disorder, urinary tract infection, nocturia, dysmenorrhea, amenorrhea, dysuria, oliguia, albuminuria, breast pain, kidney calculus, kidney pain, spontaneous abortion, threatened abortion, breast neoplasm, endometrial disorder, femal lactation, hematuria, impotence, mastitis, nephritis, prostatic disorder, testis disorder, urinary incontinence, urinary retention, uterine hemorrhage
breast enlargement, carcinoma (breast), carcinoma (cervix), ejaculation abnormal, gynecomastia, hypomenorrhea, kidney failure, placenta previa, urinary tract disorder
Adverse Events Occuring After Discontinuation: Abdominal pain, anxiety, asthenia, deulsion, depression, diarrhea, dizziness, hypertention, insomnia, nausea and vomiting
U.S. Brand Names: Pondimin (withdrawn)
Reason for Withdrawal from the Market: See information under Dexfenfluramine above.
Use: Fenfluramine is an appetitie suppressant and is used to manage exogenous obesity on a short-term (a few weeks) basis.
Contraindications: Patients with glaucoma or with hypersensitivity to fenfluramine or other sympathomimetic amines should not use this product. Do not use with MAOI's inhibitors. Do not use with alcohol or with drugs. Do not use if have a history of psychotic illness. Use with caution when using potent anesthetic agents.
Pregnancy: Do not use while pregnant or while lactating.
Drug Interactions: Use with caution with other CNS depressant drugs.
NERVOUS SYSTEM: Drowsiness, dizziness, confusion, incoordination, headache, elevated mood, depression, anxiety, nervousness, or tension, insomnia, weakness or fatigue, increased or decreased libido, agitation, dysarthria
GASTROINTESTINAL: Constipation, abdominal pain, nausea, diarrhea, dry mouth
AUTONOMIC: Dysuria, Urinary frequency
CARDIOVASCULAR: Palpiation, hyoptension, hypertension, fainting, pulmonary hypertension
SKIN: Rash, urticaria, burning sensation
MISC: Eye irritation, myaligia, fever, chest pain, bad taste
U.S. Brand Names: Tenuate, Tenuate dospan
Use: Diethylpropion is used for the short term managment of exogenous obesity.
Contraindications: Use caution if have arteriosclerosis, hyperthyroidism, hypersensitivity to the sympathomimetic amines, glaucoma, or severe hypertension. Do not use if have a history of agitated states, drug abuse, or are using MAOI's inhibitors.
Pregnancy and Lactation: Do not use during pregnancy or while lactating (this drug is execreted in human milk).
Drug Interactions: May alter antidiabetic drug requirements. Use with general anesthetics may result in arrhythmias. Do not use concurrently with phenothiazines.
CARDIOVASCULAR: Precordial pain, arrhythmia, ECG changes, tachycardia, elevation of blood pressure, palpitation
CENTRAL NERVOUS SYSTEM: Rarely an increase in convulsive episodes in epileptics, rare psychotic episodes, dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache
GASTROINTESTINAL: Vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation, other gastrointestinal disturbances
ALLERGIC: Utricaria, rash, ecchymosis, erthema
ENDOCRINE: Impotence, changes in libido, gynecomastia, menstrual upset
HEMATOPOLETIC SYSTEM: Bone marrow depression, agranulocytosis, leukopenia
MISC: Dysuria, dyspnea, hair loss, muscle pain, increased sweating, polyuria
U.S. Brand Names: Bontril, Plegine, Prelu-2, X-Trozine
Use: Use for the short term weight loss management of exogenous obesity.
Contraindications: Do not use if have hypersensitivity to sympathomimetics. Do not use if have advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, or glaucoma.
Pregnancy: Do not use while pregnant or lactating.
CARDIOVASCULAR: Palpitation, tachycardia, elevation of blood pressure
CENTRAL NERVOUS SYSTEM: Overstimulation, restlessness, dizziness, insomnia, tremor, headache, psychotic state, agitation, flushing, sweating blurring of vision
GASTROINTESTINAL: Dryness of the mouth, diarrhea, constipation, nausea, stomach pain
GENITOURINARY: Changes in libido, urinary frequency, dysuria
U.S. Brand Names: Adipex-P, Fasting, Ionamin, Obytrim
Use: Use Phentermine for the short term weight loss managment of exogenous obesity.
Contraindications: Do not use if have advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity to the sympathomimetic amines, or glaucoma. Do not use if have a history of agitated states or of drug abuse or if are using an MAOI inhibitor.
Do not use with alcohol.
Warnings: Use caution when driving or operating heavy machinery as this drug may impair these abilities.
Pregnancy and Lacation: Unknown how this drug affects pregnant or lactating women so use with caution if must use.
CARDIOVASCULAR: Palpitation, tachycardia, elevation of blood pressure
CENTRAL NERVOUS SYSTEM: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headche, rarely psychotic episodes at recommended doses.
GASTROINTESTINAL: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastronintestinal disturbances
ENDOCRINE: Impotence, changes in libido