Tenuate (Diethylpropion) Contraindications/Precautions
- anorexia nervosa
- arteriosclerosis
- cardiac arrhythmias
- children
- glaucoma
- hypertension
- hyperthyroidism
- pulmonary hypertension
- substance abuse
- valvular heart disease
- abrupt discontinuation
- breast-feeding
- elderly
- mania
- pregnancy
- psychosis
- renal failure
- renal impairment
- seizure disorder
- surgery
- thyroid disease
Tenuate (Diethylpropion) Contraindications/Precautions
Patients with anorexia nervosa should not receive anorexiants, since this could worsen the patient’s nutritional status. Further, diethylpropion should not be prescribed to patients who have been treated with anorexiant drugs in the preceding 12 months.
Due to its vasopressor effects, diethylpropion is contraindicated in patients with symptomatic cardiovascular disease including advanced arteriosclerosis, moderate to severe hypertension, or cardiac arrhythmias. Diethylpropion is not recommended in patients with known heart murmur or valvular heart disease. Valvular heart disease is associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine. Cardiac valvulopathy has been very rarely reported with diethylpropion monotherapy, but the causal relationship remains uncertain. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. Baseline cardiac evaluation should be considered to detect preexisting valvular heart diseases or pulmonary hypertension prior to initiation of diethylpropion treatment. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. In a case-control epidemiological study, the use of anorectic agents, including diethylpropion, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than 3 months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, diethylpropion should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension. The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss.
Because diethylpropion is a sympathomimetic agent, its use should be avoided in patients with glaucoma or thyroid disease with hyperthyroidism.
Diethylpropion is contraindicated in patients with a history of substance abuse. Diethylpropion is chemically and pharmacologically related to the amphetamines, which have been extensively abused. Physiological dependence can occur with diethylpropion. Abrupt discontinuation of prolonged high dose diethylpropion therapy can result in extreme fatigue and mental depression as well as changes in sleep EEG. If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
Diethylpropion should be used cautiously in patients with psychosis, mania, or agitated states. Amphetamine-like agents have been shown to aggravate these conditions.
Safety and effectiveness of diethylpropion in children have not been established. Diethylpropion is not recommended for patients under 16 years of age.
Reports suggest that diethylpropion may increase the risk of seizures in some epileptic patients. Patients with a seizure disorder receiving diethylpropion should be closely monitored.
Diethylpropion is classified as FDA pregnancy risk category B. Diethylpropion and/or its metabolites are thought to cross the placental barrier. No adequate, well controlled studies exist in pregnant women, however, diethylpropion is not approved for use pregnant women. Animal data reveal no harmful effects during pregnancy. Spontaneous reports of congenital malformation have been reported in humans, but no causal relationship to diethylpropion has been established. Diethylpropion hydrochloride and its metabolites have been shown to be excreted into breast milk. It is unknown if diethylpropion or its metabolites will cause harm to the nursing infant. Caution should be exercised when diethylpropion is used during breast-feeding or pregnancy.
The use of inhalational anesthetics during surgery may sensitize the myocardium to the effects of sympathomimetic drugs. Because of this, and its effects on blood pressure, diethylpropion should be discontinued several days prior to surgery.
Adequate numbers of elderly patients were not included in diethylpropion clinical trials to determine if their response would be different from younger patients, although differences have not been seen. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range due to potential decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy. Diethylpropion is known to be substantially excreted by the kidney. Because elderly patients are more likely to have renal impairment or renal failure, care should be taken in dose selection and monitoring.
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