"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 "...
Cardiovascular: Precordial pain, arrhythmia (including ventricular), ECG changes, tachycardia, elevation of blood pressure, palpitation and rare reports of pulmonary hypertension. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination, have been reported. Valvulopathy has been very rarely reported with TENUATE (diethylpropion) or TENUATE (diethylpropion) DOSPAN monotherapy, but the causal relationship remains uncertain.
Central Nervous System: In a few epileptics an increase in convulsive episodes has been reported; rarely psychotic episodes at recommended doses; dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache, and cerebrovascular accident
Miscellaneous: A variety of miscellaneous adverse reactions has been reported by physicians.
Drug Abuse And Dependence
TENUATE (diethylpropion) and TENUATE DOSPAN are schedule IV controlled substances. Diethylpropion hydrochloride has some chemical and pharmacologic similarities to the amphetamines and other related stimulant drugs that have been extensively abused. There have been reports of subjects becoming psychologically dependent on diethylpropion. The possibility of abuse should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with varying degrees of psychologic dependence and social dysfunction which, in the case of certain drugs, may be severe. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
Read the Tenuate (diethylpropion) Side Effects Center for a complete guide to possible side effects
Because TENUATE (diethylpropion) and TENUATE (diethylpropion) DOSPAN are monoamines, hypertension may result when either agent is used with monoamine oxidase (MAO) inhibitors (See CONTRAINDICATIONS). Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic agents is contraindicated.
Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.
Read the Tenuate Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/21/2007
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