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 amfepramone. 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 amfepramone has been established.
Abuse with amfepramone during pregnancy may result in withdrawal symptoms in the human neonate.
Since amfepramone and/or its metabolites have been shown to be excreted in human milk, caution should be exercised when amfepramone extended release tablets, 75 mg are administered to a nursing woman.
No long-term animal studies have been done to evaluate amfepramone for carcinogenicity. Mutagenicity studies have not been conducted. Animal reproduction studies have revealed no evidence of impairment of fertility.
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 diethylpropion hydrochloride extended release tablets, 75 mg 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
Gastrointestinal: Vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation, other gastrointestinal disturbances
Allergic: Urticaria, rash, ecchymosis, erythema
Endocrine: Impotence, changes in libido, gynecomastia, menstrual upset
Hematopoietic System: Bone marrow depression, agranulocytosis, leukopenia
Miscellaneous: A variety of miscellaneous adverse reactions has been reported by physicians. These include complaints such as dysuria, dyspnea, hair loss, muscle pain, increased sweating, and polyuria.
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