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warnings
WARNINGS Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility : Impairment of Fertility . There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility .) The glucocorticoid activity of megestrol acetate oral suspension, USP has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol acetate therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic megestrol acetate therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection).
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Akorn Operating Company LLC at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Clinical Adverse Events Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing megestrol acetate oral suspension. ADVERSE EVENTS % of Patients Reporting Megestrol Acetate, mg/day No. of Patients Trial 1 (N=236) Placebo 0 100 400 800 N=34 N=68 N=69 N=65 Trial 2 (N=87) Placebo 0 800 N=38 N=49 Open Label Trial 1200 N=176 Diarrhea Impotence Rash Flatulence Hypertension Asthenia Insomnia Nausea Anemia Fever Libido Decreased Dyspepsia Hyperglycemia Headache Pain Vomiting Pneumonia Urinary Frequency 15 13 8 15 3 4 6 14 9 9 4 12 9 0 1 9 0 0 0 8 3 2 3 6 0 3 4 6 9 4 0 5 6 3 3 5 3 6 4 5 3 4 0 5 0 0 3 3 3 0 6 3 6 10 1 3 6 0 0 2 9 3 0 2 6 2 0 2 0 0 1 2 8 6 1. 4 3 2 3 10 2. 0 8 4 3. 0 3 4 4. 0 3 2 5. 2 5 4 6. 0 3 0 5 6 3 6 3 0 5 2 10 7 6 6 4 5 1 5 0 1 1 2 3 3 4 4 1 1 Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo. Body as a Whole: abdominal pain, chest pain, infection, moniliasis and sarcoma Cardiovascular System: cardiomyopathy and palpitation Digestive System: constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis Hemic and Lymphatic System: leukopenia Metabolic and Nutritional: LDH increased, edema and peripheral edema Nervous System: paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking Respiratory System: dyspnea, cough, pharyngitis and lung disorder Skin and Appendages: alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder Special Senses: amblyopia Urogenital System: albuminuria, urinary incontinence, urinary tract infection and gynecomastia Postmarketing Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS ).