SEROTONERGIC DRUGS

MERIDIA

COMBINATION DRUGS

FAT BLOCKERS

METFORMIN

OTC, HERBS, VITAMINS

CHROMIUM PICOLINATE

It is estimated that 14% of adults are using prescription weight loss products and another 7% are using OTC weight loss medications.

Criteria for efficacy:

Use results in weight loss of at least 5% of initial body weight and maintenance of that loss.

Reduction of comorbidities such as hyperglycemia, hypertension, dyslipidemias.

Minimum of tolerable side effects. Noradrenergic drugs Suppress appetite by direct stimulation of the satiety center in the hypothalamic and limbic regions of the brain. Amphetamines have high abuse potential; there is no clinical need for these drugs in the treatments of obesity. Structurally similar drugs have appetite suppressing effects with lower risk for CNS stimulation and abuse.

Generic Name

Trade Name

Dosage Form, Strength

Dosage Regimen

DEA Schedule

Diethylpropion

Tenuate Tepanil Tenuate

Tablet: 25 mg Dospan: 75 mg Ten-Tab: 75 mg

25 mg 3 times daily, 1 hour before meals, and in mid-evening if needed. Sustained release 75mg once daily, mid-morning

IV

Phentermine

Phentermine (various mfg.) Fastin Ionamin

Tablet: 8 mg Capsule: 8 mg Sustained release capsule: 30 mg Sustained release capsule: 15, 30 mg

8 mg 3 times daily, ½ hour before meals, or 15 to 30 mg as a single daily dose before breakfast or 10-14 hours before bedtime

IV

Phenylpropanolamine

Dexatrim Pre-Meal Prolamine Acutrim 16 Hour

Capsule: 25 mg Capsule: 37.5 mg Tablet: 75 mg

25 mg 3 times daily, not to exceed 75 mg in 24 hours, or 75 mg once daily (as sustained release)

Was OTC- pulled from market in 2000 due to increased incidence in hemorrhagic stroke

Side effects: CNS stimulation, blood pressure elevation, false sense of well being, irritability, nervousness, restlessness, insomnia. After the effects have worn off, unusual fatigue or weakness, drowsiness, trembling, mental depression.

Serotonergic drugs The increased serotonin is thought to be responsible for satiation, and thereby reduces food intake. Fluoxetine (Prozac) Dosing: Recommended daily dose for weight loss id 60 mg Side effects: Anxiety, nervousness, diarrhea, and drowsiness Efficacy: Weight loss slows after first few months of therapy and is minimal by months 6 to 10.

Fenfluramine (Pondimin)- withdrawn from market 1997 Dexfenfluramine (Redux)- withdrawn from market 1997

Sibutrimine (Meridia) DEA schedule: class IV Action: Promotes appetite control by inhibiting the reuptake of norepinephrine, serotonin and dopamine. Dosing Comes in 5, 10 and 15 mg capsules. The recommended starting dose id 10 mg daily, and increase depending on patient tolerance to 15 mg daily. The 5 mg dose is reserved for patients not tolerating the 10 mg dose. Titration is dependent on blood pressure and heart rate. The safety and efficacy of use longer than 1 year has not been evaluated. Side effects: Most commonly dry mouth, constipation, and insomnia. Others include headache, increased sweating, increase in blood pressure (sometimes substantial- blood pressure must be monitored regularly), increase in heart rate. Primary pulmonary hypertension has been reported with other weight loss drugs in this class. Efficacy: Studies showed an average weight loss of 4.4 to 6.9 kg over 12 weeks. Approximate cost: $90 per month

Combination “Fen-phen” combination was tested at doses of fenfluramine 60mg plus phentermine 15 mg (half the usual dose of each drug) in 121 men and women for 210 weeks. 48 of the patients were still participating in the study at its conclusion. The adverse effects noted were dry mouth, GI symptoms such as abdominal pain, nausea, metallic taste, diarrhea and constipation, and fatigue. These studies concluded that the drugs retained their effectiveness without serious adverse events. However, widespread use of the drug combination revealed an incidence of 18 million cases per million of primary pulmonary hypertension and the occurrence of valvular heart disease.

Fat blocking drugs Orlistat (Xenical) Action: Inhibits the absorption of dietary fats. Dosing: 120 mg 3 times daily (or with each meal, may skip with non-fat meals) + multivitamin to supplement fat-soluble vitamins. Side effects: Most commonly oily spotting, flatus with discharge, fecal urgency, fatty/ oily stool, oily evacuation, increased defecation, and fecal incontinence. Side effect management: Psillium (Metamucil) 10-15 ml (12 grams) with water at bedtime, or 1 rounded teaspoonful (6 grams) with each dose, to adsorb the oily discharge, panty liners as patient adjusts to drug. Efficacy: Studies showed a weight loss of 5.6 to 6.1 kg at one year. Approximate cost: $105 per month (120 mg TID)

Metformin (Glucophage) Action: Decreases insulin resistance. Dosing: 1500 mg/day, start with 500 mg daily-> BID-> TID Side effects: GI upset, diarrhea Efficacy: Studies show 9- 13 kg weight loss at one year when combined with low carbohydrate diet. Approximate cost: $66 per month

OTC drugs, herbal, vitamin, trace elements Metabolife Contains: Vitamin E, Magnesium, Zinc, Chromium, Guarana Concentrate (40 mg naturally occurring caffeine), Ma Huang Concentrate (12 mg naturally occurring ephedrine), Bee Pollen, Ginseng, Ginger, Lecithin, Bovine Complex, Damiana, Sarsaparilla, Golden Seal, Nettles, Gotu, Kola, Spirulina Algae, Royal Jelly, L-Carnitine-L-Tartrate, Gymnema Sylvestre. Warnings: Donot use if pregnant, nursing, heart disease, thyroid disease, diabetes, high blood pressure, depression, or other psychiatric condition, glaucoma, difficulty urinating, prostate enlargement, seizure disorder, using an MAO inhibitor, or any other prescription drug containing ephedrine, pseudoephedrine, or phenylpropanolamine.

Ephedra warning: The herb industry is largely unregulated compared to FDA standards. With the market withdrawal of phenylpropanolamine, many “herbal” weight loss drugs have been marketed. Many of these contain ephedra as a pharmacologic means to stimulate metabolism. Ephedra can be referred to as many different products: ephedra herba, desert herb, ma huang, joint fir, popotillo, sea grape, teamster’s tea, and yellow horse.

What to warn your patients about: Physiologic effects: Amphetamine-like effect, stimulation of alpha-1, beta-1, and beta-2 receptors which increase heart rate, peripheral vascular resistance, and blood pressure. Many of the marketed products also contain caffeine. When used with other stimulants, ephedra use was associated with adverse effects such as heart palpitations, psychiatric effects, gastrointestinal effects, symptoms of autonomic hyperactivity, including tremor and insomnia. Dangerous drug interactions: with non-cardioselective beta blockers could result in an increased pressor effect from unopposed alpha receptor stimulation. With MAO inhibitors (isocarboxazid Ò Marplan, phenelzine ÒNardil, tranylcypromine Ò Parnate) severe hypertension can result. All patients undergoing anesthesia with halogenated general anesthetics need to stop all ephedra use prior to surgery to avoid drug interactions. Adverse effects: Hypertension, palpitation, tachycardia, stroke, and seizures. The American Association of Poison Control Centers reported 1178 adverse reactions related to ephedra in 2001. This is 64% of the adverse reactions reported secondary to commonly used herbs, but ephedra products are only 0.82% of the herbal products for sale. This translates to a 10 to 40 fold higher risk of an adverse reaction with ephedra use.

Chromium picolinate Action enhances glucose metabolism Dosing: There is no RDA, but intake of 50 to 200 mcg daily has been deemed safe. Efficacy: Anecdotal

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