FENFLURAMINE HYDROCHLORIDE (PONDIMINTM)
20mg tablets
Anorectics that are currently FDA approved, are centrally acting appetite suppressants which work via adrenergic or serotonergic pathways. Noradrenergic agents, such as phentermine, cause anorexia by releasing catecholamines from nerve endings and/or inhibiting reuptake and are often associated with mild CNS stimulant side effects. Serotonin causes a decrease in the physiological level of activity including a reduction in food intake and somnolence. Thus, drugs which release serotonin and/or block its reuptake decrease food intake and body weight. Fenfluramine both releases and prevents the reuptake of serotonin and unlike other drugs in this class, can produce CNS depression.
Historically, drug regimens for weight loss have consisted of the short term use of a single agent and are associated with a high relapse rate (weight gain), approximating 95% at 5 year follow-up. In theory, use of anorectic drugs with different mechanisms of action may be used in combination to enhance efficacy, reduce tolerance and allow lower dosages than when agents are used alone.
The most common adverse events cited in clinical trials, resulting from the combination use of phentermine and fenfluramine, are gastrointestinal (dry mouth, unpleasant taste, nausea, vomiting, abdominal discomfort, diarrhea, and constipation) and CNS (drowsiness, sleep disturbances, nervousness, and increased dreaming) in nature. Palpitations and decreased libido occur infrequently. Continuous therapy is associated with fewer side effects than intermittent regimens. There have been isolated reports of ischemic stroke and psychosis associated with phentermine use/misuse.
| Phentermine: | Single daily dose: 15-37.5mg before breakfast or 10-14 hours before bedtime. |
| Fenfluramine: | 20mg TID before meals. May increase at weekly intervals by 20mg daily to a maximum of 40mg TID. |
These two medications may be prescribed concomitantly for obesity and have been added to the KUMC Formulary. The Pharmacy and Therapeutics Committee has approved their use in the Obesity Clinic and Family Practice/Medicine Clinics at KUMC utilizing the protocol developed by Dr. Shadrach Smith.
| Eligible Patients: | Patients weighing greater than 130% of ideal body weight or weighing greater than 120% of ideal body weight with co-morbidities. Patients must also have no history of substance abuse. |
| Patient Evaluations: | Include history, physical, and laboratory data. |
| Medical Therapy: | Medications - anorectic medications limited to uncontrolled and class IV
controlled substances in dosages consistent with manufacturer recommendations. Combination Therapy - limited to treatment regimens using agents from different classes and based on positive results published in peer reviewed journals. Support Therapy - consisting of nutritional, psychological and physiological support. |
| Informed Consent: | When applicable. |
| Continued Medical Therapy: | Based on initial response and maintenance of weight loss. |
| Return Visits: | Specified intervals between visits and specified services to be provided on follow-up visits. |
