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adverse reactions
ADVERSE EVENTS The premarketing development program for EMSAM included selegiline exposures in patients and/or normal subjects from two different groups of studies: 702 healthy subjects in clinical pharmacology/pharmacokinetics studies and 2036 exposures from patients in controlled and uncontrolled major depressive disorder clinical trials. The conditions and duration of treatment with EMSAM varied and included double-blind, open-label, fixed-dose, and dose titration studies of short-term and longer-term exposures. Safety was assessed by monitoring adverse events, physical examinations, vital signs, body weights, laboratory analyses, and ECGs. Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators. In the tables and tabulations that follow, standard COSTART terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Adverse Findings Observed in Short-Term Placebo-Controlled Trials Adverse Events Associated with Discontinuation of Treatment Among 817 depressed patients who received EMSAM at doses of either 3 mg/24 hours (151 patients), 6 mg/24 hours (550 patients) or 6 mg/24 hours, 9 mg/24 hours, and 12 mg/24 hours (116 patients) in placebo-controlled trials of up to 8 weeks in duration, 7.1% discontinued treatment due to an adverse event as compared with 3.6% of 668 patients receiving placebo. The only adverse event associated with discontinuation, in at least 1% of EMSAM -treated patients at a rate at least twice that of placebo, was application site reaction (2% EMSAM vs. 0% placebo). Adverse Events Occurring at an Incidence of 2% or More Among EMSAM -Treated Patients Table 2 enumerates adverse events that occurred at an incidence of 2% or more (rounded to the nearest percent) among 817 depressed patients who received EMSAM in doses ranging from 3 to 12 mg/24 hours in placebo-controlled trials of up to 8 weeks in duration. Events included are those occurring in 2% or more of patients treated with EMSAM and for which the incidence in patients treated with EMSAM was greater than the incidence in placebo-treated patients. Only one adverse event was associated with a reporting of at least 5% in the EMSAM group, and a rate at least twice that in the placebo group, in the pool of short-term, placebo-controlled studies: application site reactions (see Application Site Reactions , below). In one such study which utilized higher mean doses of EMSAM than that in the entire study pool, the following events met these criteria: application site reactions, insomnia, diarrhea, and pharyngitis. These figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physicians with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied. Table 2. Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials for Major Depressive Disorder With EMSAM Events reported by at least 2% of patients treated with EMSAM are included, except the following events, which had an incidence on placebo treatment ≥ EMSAM : infection, nausea, dizziness, pain, abdominal pain, nervousness, back pain, asthenia, anxiety, flu syndrome, accidental injury, somnolence, rhinitis, and palpitations. Body System/Preferred Term EMSAM (N = 817) Placebo (N = 668) (% of Patients Reporting Event) Body as a Whole Headache 18 17 Digestive Diarrhea 9 7 Dyspepsia 4 3 Nervous Insomnia 12 7 Dry Mouth 8 6 Respiratory Pharyngitis 3 2 Sinusitis 3 1 Skin Application Site Reaction 24 12 Rash 4 2 Application Site Reactions In the pool of short-term, placebo-controlled major depressive disorder studies, application site reactions (ASRs) were reported in 24% of EMSAM -treated patients and 12% of placebo-treated patients. Most ASRs were mild or moderate in severity. None were considered serious. ASRs led to dropout in 2% of EMSAM -treated patients and no placebo-treated patients. In one such study which utilized higher mean doses of EMSAM , ASRs were reported in 40% of EMSAM -treated patients and 20% of placebo-treated patients. Most of the ASRs in this study were described as erythema and most resolved spontaneously, requiring no treatment. When treatment was administered, it most commonly consisted of dermatological preparations of corticosteroids. Male and Female Sexual Dysfunction with MAO Inhibitors Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence. Table 3 shows that the incidence rates of sexual side effects in patients with major depressive disorder are comparable to the placebo rates in placebo-controlled trials. Table 3. Incidence of Sexual Side Effects in Placebo-Controlled Clinical Trials With EMSAM Adverse Event EMSAM Placebo IN MALES ONLY (N = 304) (N = 256) Abnormal Ejaculation 1.0% 0.0% Decreased Libido 0.7% 0.0% Impotence 0.7% 0.4% Anorgasmia 0.2% 0.0% IN FEMALES ONLY (N = 513) (N = 412) Decreased Libido 0.0% 0.2% There are no adequately designed studies examining sexual dysfunction with EMSAM treatment. Vital Sign Changes EMSAM and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure), and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. In the pool of short-term, placebo-controlled major depressive disorder studies, 3.0% of EMSAM -treated patients and 1.5% of placebo-treated patients experienced a low systolic blood pressure, defined as a reading less than or equal to 90 mmHg with a change from baseline of at least 20 mmHg. In one study which utilized higher mean doses of EMSAM , 6.2% of EMSAM -treated patients and no placebo-treated patients experienced a low standing systolic blood pressure by these criteria. In the pool of short-term major depressive disorder trials, 9.8% of EMSAM -treated patients and 6.7% of placebo-treated patients experienced a notable orthostatic change in blood pressure, defined as a decrease of at least 10 mmHg in mean blood pressure with postural change. Weight Changes In placebo-controlled studies (6 - 8 weeks), the incidence of patients who experienced ≥5% weight gain or weight loss is shown in Table 4. Table 4. Incidence of Weight Gain and Weight Loss in Placebo-Controlled Trials With EMSAM Weight Change EMSAM Placebo (N = 757) (N = 614) Gained ≥ 5% 2.1% 2.4% Lost ≥ 5% 5.0% 2.8% In these trials, the mean change in body weight among EMSAM -treated patients was -1.2 lbs compared to + 0.3 lbs in placebo-treated patients. Laboratory Changes EMSAM and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with EMSAM . ECG Changes Electrocardiograms (ECGs) from EMSAM (N = 817) and placebo (N = 668) groups in controlled studies were compared with respect to (1) mean change from baseline in various ECG parameters, and (2) the incidence of patients meeting criteria for clinically significant changes from baseline in these variables. No clinically meaningful changes in ECG parameters from baseline to final visit were observed for patients in controlled studies. Other Events Observed During the Premarketing Evaluation of EMSAM During the premarketing assessment in major depressive disorder, EMSAM was administered to 2036 patients in Phase III studies. The conditions and duration of exposure to EMSAM varied and included double-blind and open-label studies. In the tabulations that follow, reported adverse events were classified using a standard COSTART-based dictionary terminology. All reported adverse events are included except those already listed in Table 2 or elsewhere in labeling, and those events occurring in only one patient. It is important to emphasize that although the events occurred during treatment with EMSAM ,they were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients. Body as a Whole: Frequent: Chest pain, neck pain. Infrequent: Bacterial infection, fever, cyst, fungal infection, chills, viral infection, suicide attempt, neck rigidity, pelvic pain, photosensitivity reaction, face edema, flank pain, hernia, intentional injury, neoplasm, generalized edema, overdose. Rare: Body odor, halitosis, heat stroke, parasitic infection, malaise, moniliasis. Cardiovascular System: Frequent: Hypertension. Infrequent: Vasodilatation, tachycardia, migraine, syncope, atrial fibrillation, peripheral vascular disorder. Rare: Myocardial infarct. Digestive System: Frequent: Constipation, flatulence, anorexia, gastroenteritis, vomiting. Infrequent: Increased appetite, thirst, periodontal abscess, eructation, gastritis, colitis, dysphagia, tongue edema, glossitis, increased salivation, abnormal liver function tests, melena, tongue disorder, tooth caries. Rare: GI neoplasia, rectal hemorrhage. Hemic and Lymphatic System: Frequent: Ecchymosis. Infrequent: Anemia, lymphadenopathy. Rare: Leukocytosis, leukopenia, petechia. Metabolic and Nutritional: Frequent: Peripheral edema. Infrequent: Hyperglycemia, increased SGPT, edema, hypercholesteremia, increased SGOT, dehydration, alcohol intolerance, hyponatremia, increased lactic dehydrogenase. Rare: Increased alkaline phosphatase, bilirubinemia, hypoglycemic reaction. Musculoskeletal System: Frequent: Myalgia, pathological fracture. Infrequent: Arthralgia, generalized spasm, arthritis, myasthenia, arthrosis, tenosynovitis. Rare: Osteoporosis. Nervous System: Frequent: Agitation, paresthesia, thinking abnormal, amnesia. Infrequent: Leg cramps, tremor, vertigo, hypertonia, twitching, emotional lability, confusion, manic reaction, depersonalization, hyperkinesias, hostility, myoclonus, circumoral paresthesia, hyperesthesia, increased libido, euphoria, neurosis, paranoid reaction. Rare: Ataxia. Respiratory System: Frequent: Cough increased, bronchitis. Infrequent: Dyspnea, asthma, pneumonia, laryngismus. Rare: Epistaxis, laryngitis, yawn. Skin and Appendages: Frequent: Pruritus, sweating, acne. Infrequent: Dry skin, maculopapular rash, contact dermatitis, urticaria, herpes simplex, alopecia, vesiculobullous rash, herpes zoster, skin hypertrophy, fungal dermatitis, skin benign neoplasm. Rare: Eczema. Special Senses: Frequent: Taste perversion, tinnitus. Infrequent: Dry eyes, conjunctivitis, ear pain, eye pain, otitis media, parosmia. Rare: Mydriasis, otitis external, visual field defect. Urogenital System: Frequent: Urinary tract infection, urinary frequency, dysmenorrhea, metrorrhagia. Infrequent: Urinary tract infection (male), vaginitis, cystitis (female), hematuria (female), unintended pregnancy, dysuria (female), urinary urgency (male and female), vaginal moniliasis, menorrhagia, urination impaired (male), breast neoplasm (female), kidney calculus (female), vaginal hemorrhage, amenorrhea, breast pain, polyuria (female).