"U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration, today seized tainted dietary supplements from Globe All Wellness, LLC (Globe All), in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active "...
TENUATE (diethylpropion) and TENUATE (diethylpropion) 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 (diethylpropion) or TENUATE (diethylpropion) 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 (diethylpropion) and TENUATE (diethylpropion) 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 (diethylpropion) or TENUATE (diethylpropion) DOSPAN treatment. TENUATE (diethylpropion) and TENUATE (diethylpropion) 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 (diethylpropion) or TENUATE (diethylpropion) 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 (diethylpropion) and TENUATE (diethylpropion) 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 (diethylpropion) or TENUATE (diethylpropion) 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.
Caution is to be exercised in prescribing TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN for patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias. TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN should not be administered to patients with severe hypertension.
Reports suggest that diethylpropion hydrochloride may increase convulsions in some epileptics. Therefore, epileptics receiving TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN should be carefully monitored. Titration of dose or discontinuance of TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN may be necessary.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No long-term animal studies have been done to evaluate diethylpropion hydrochloride for carcinogenicity. Mutagenicity studies have not been conducted. Animal reproduction studies have revealed no evidence of impairment of fertility (see Pregnancy).
Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 1.6 times the human dose (based on mg/m2) and have revealed no evidence of impaired fertility or harm to the fetus due to diethylpropion hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Spontaneous reports of congenital malformations have been recorded in humans, but no causal relationship to diethylpropion has been established.
Non-Teratogenic Effects. Abuse with diethylpropion hydrochloride during pregnancy may result in withdrawal symptoms in the human neonate.
Since diethylpropion hydrochloride and/or its metabolites have been shown to be excreted in human milk, caution should be exercised when TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN is administered to a nursing woman.
Clinical studies of TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug in known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Since safety and effectiveness in pediatric patients below the age of 16 have not been established, TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN is not recommended for use in pediatric patients 16 years of age and under.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/21/2007
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