Tenuate (Diethylpropion) Adverse Reactions
- abdominal pain
- agitation
- alopecia
- angina
- anxiety
- blurred vision
- cardiac valvulopathy
- chest pain (unspecified)
- coma
- confusion
- constipation
- delirium
- diaphoresis
- diarrhea
- dizziness
- dysgeusia
- dyskinesia
- dysphoria
- dyspnea
- euphoria
- flushing
- gynecomastia
- hallucinations
- headache
- hypertension
- hypotension
- impotence
- insomnia
- libido decrease
- libido increase
- menstrual irregularity
- mydriasis
- nausea/vomiting
- ocular irritation
- pallor
- palpitations
- paranoia
- psychological dependence
- psychosis
- pulmonary hypertension
- restlessness
- rhabdomyolysis
- seizures
- sinus bradycardia
- sinus tachycardia
- stroke
- tachypnea
- tolerance
- torsade de pointes
- tremor
- urticaria
- withdrawal
- xerostomia
Tenuate (Diethylpropion) Adverse Reactions
The incidence of central nervous system adverse reactions associated with diethylpropion therapy are less common and less severe than those symptoms attributed to amphetamine. Central nervous system adverse reactions noted to occur with diethylpropion therapy include agitation, confusion, dizziness, dyskinesia, dysphoria, headache, insomnia, restlessness, and tremor. Psychosis associated with diethylpropion therapy has been reported with therapeutic as well as high doses, but is more common in previous abusers of stimulant medications. Hallucinations have occurred rarely following high doses of the drug. Several cases of toxic psychosis have been reported following 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. Seizures may be more frequent in epileptic patients receiving diethylpropion. Psychological dependence may occur with diethylpropion, but is much less common than other amphetamine-like agents such as dextroamphetamine and phentermine. The low abuse potential of diethylpropion is related to the lower incidence of euphoria as compared to other amphetamine-like drugs. Prolonged use of diethylpropion may induce physiological dependence leading to a withdrawal syndrome on cessation of therapy. Psychosis has also been reported following abrupt withdrawal of diethylpropion therapy. It is advised to avoid abrupt discontinuation of therapy.
Cardiovascular adverse effects due to diethylpropion include hypertension, precordial pain, palpitations, ECG changes, cardiac arrhythmias (including ventricular arrhythmias and sinus tachycardia), and stroke. A reflex sinus bradycardia is common, though usually not clinically significant. The occurrence of torsade de pointes in a patient receiving diethylpropion has been reported. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. 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.
Tolerance is common with the entire class of amphetamine-like drugs. Tolerance to the anorexiant effects of diethylpropion may develop within a few weeks of starting therapy and higher doses of diethylpropion are required to produce the same response. The long term pharmacologic benefit of diethylpropion may be maintained by utilizing pulse dosing. Once the weight loss appears to slow or stop, the drug is held for several weeks and is then restarted.
Anorectic agents have been associated with pulmonary hypertension. A case-control study assessed 95 patients with primary pulmonary hypertension and 355 controls from 35 centers in Europe. When the previous year was assessed, patients with primary pulmonary hypertension were 10 times as likely to have received anorectic agents (mainly derivatives of fenfluramine) and were 23 times as likely to have received anorectic agents for greater than 3 months when compared to controls. Although this does not prove causality, the manufacturer of diethylpropion recommends that treatment be discontinued if symptoms of pulmonary hypertension (e.g., dyspnea upon exertion, syncope, chest pain (unspecified), palpitations, or cardiac insufficiency) occur. Primary pulmonary hypertension has been reported to occur in patients receiving a combination of diethylpropion with fenfluramine or dexfenfluramine. The onset or aggravation of exertional dyspnea, angina pectoris, syncope, or lower extremity edema may suggest the occurrence of pulmonary hypertension, and patients with these symptoms should discontinue use of diethylpropion immediately. Patients should be advised to report immediately any deterioration in exercise tolerance.
Ocular adverse effects of diethylpropion include blurred vision, mydriasis, and ocular irritation.
The most common gastrointestinal adverse effects of diethylpropion are constipation and xerostomia. Other adverse effects include abdominal pain, diarrhea, dysgeusia, nausea/vomiting.
Toxic effects of amphetamine-like agents (e.g., diethylpropion) appear to occur over a wide dosage range. Practitioners should be alert to the signs of excessive dosages or overdose which may include: angina, anxiety, agitation, blurred vision, delirium, diaphoresis, flushing or pallor, hallucinations, hypotension or hypertension, mydriasis, palpitations, paranoia, psychosis, sinus tachycardia, tachypnea, or tremor. Minor manifestations of any of these symptoms during prescription use indicates a need for dosage reduction or discontinuation. Severe manifestations of diethylpropion overdose include cardiac arrhythmias including heart block, circulatory collapse, rhabdomyolysis, seizures, coma, and death.
Other adverse reactions to diethylpropion include alopecia, gynecomastia, impotence, libido increase, libido decrease, menstrual irregularity, and urticaria.
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