Tenuate (diethylpropion) is a stimulant. As an appetite suppressant, it usually is prescribed on a short-term basis (a few weeks), in combination with diet, to help obese individuals lose weight.

Tenuate comes as a regular and extended-release (long-acting) tablet (Tenuate Dospan). The regular drug usually is taken three times a day, 1 hour before meals, and the extended-release pill is taken once a day in midmorning.

The benefits of Tenuate tend to decrease within a few weeks and its use therefore is not recommended beyond that period. It is recommended only for people with an initial body mass index (BMI) of 30 or greater (27 or greater if the person has other risk factors).

Diethylpropion is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or an "anorexigenic" drug. Diethylpropion stimulates the central nervous system (nerves and brain), which increases heart rate and blood pressure and decreases appetite. The drug also may be habit forming.

No longer a patented drug, Tenuate (originally distributed by Aventis Pharmaceuticals, now part of Sanofi-Aventis) was at one point distributed in the U.S. under the generic name diethylpropion by several pharmaceutical companies. But no generic versions of the drug are currently on the FDA's approved list.

WARNINGS:

Tenuate and Tenuate Dospan should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations, and herbal products.

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, Tenuate or Tenuate Dospan should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. Valvulopathy has been very rarely reported with Tenuate and Tenuate Dospan monotherapy, but the causal relationship remains uncertain.

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.

Baseline cardiac evaluation should be considered to detect preexisting valvular heart diseases or pulmonary hypertension prior to initiation of Tenuate or Tenuate Dospan treatment. Tenuate and Tenuate Dospan are not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be
useful for detecting any valvular disorders which may occur.

To limit unwarranted exposure and risks, treatment with Tenuate or Tenuate Dospan should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds, or as determined by the physician and patient).

Tenuate and Tenuate Dospan are not recommended for patients who used any anorectic agents within the prior year. If tolerance develops, the recommended dose should not be exceeded in an attempt to increase
the effect; rather, the drug should be discontinued.

Tenuate or Tenuate Dospan may impair the ability of the patient to engage in potentially hazardous activities such as operating
machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Prolonged use of diethylpropion hydrochloride may induce dependence with withdrawal syndrome on cessation of therapy. Hallucinations have occurred rarely following high doses of the drug. Several cases of toxic psychosis have been reported following the excessive use of the drug and some have been reported in which the recommended dose appears not to have been exceeded. Psychosis abated after the drug was discontinued.

When central nervous system active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.