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adverse reactions
ADVERSE REACTIONS Pre-Marketing Clinical Trial Experience: The specific adverse event data described in this section are based on studies of the immediate-release tablet formulation. In clinical trials, once-daily treatment with RAZADYNE ® ER (galantamine hydrobromide) Extended-Release Capsules was well tolerated and adverse events were similar to those seen with RAZADYNE ® Tablets. Adverse Events Leading to Discontinuation: In two large scale, placebo-controlled trials of 6 months duration in which patients were titrated weekly from 8 to 16 to 24, and to 32 mg/day, the risk of discontinuation because of an adverse event in the galantamine group exceeded that in the placebo group by about threefold. In contrast, in a 5-month trial with escalation of the dose by 8 mg/day every 4 weeks, the overall risk of discontinuation because of an adverse event was 7%, 7%, and 10% for the placebo, galantamine 16 mg/day, and galantamine 24 mg/day groups, respectively, with gastrointestinal adverse effects the principle reason for discontinuing galantamine. Table 1 shows the most frequent adverse events leading to discontinuation in this study. Table 1: Most Frequent Adverse Events Leading to Discontinuation in a Placebo-Controlled, Double-Blind Trial With a 4-Week Dose Escalation Schedule 4-Week Escalation Placebo 16 mg/day 24 mg/day Adverse Event N=286 N=279 N=273 Nausea <1% 2% 4% Vomiting 0% 1% 3% Anorexia <1% 1% <1% Dizziness <1% 2% 1% Syncope 0% 0% 1% Adverse Events Reported in Controlled Trials: The reported adverse events in trials using RAZADYNE ® (galantamine hydrobromide) Tablets reflect experience gained under closely monitored conditions in a highly selected patient population. In actual practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior and the types of patients treated may differ. The majority of these adverse events occurred during the dose-escalation period. In those patients who experienced the most frequent adverse event, nausea, the median duration of the nausea was 5-7 days. Administration of RAZADYNE ® with food, the use of anti-emetic medication, and ensuring adequate fluid intake may reduce the impact of these events. The most frequent adverse events, defined as those occurring at a frequency of at least 5% and at least twice the rate on placebo with the recommended maintenance dose of either 16 or 24 mg/day of RAZADYNE ® under conditions of every 4-week dose-escalation for each dose increment of 8 mg/day, are shown in Table 2 . These events were primarily gastrointestinal and tended to be less frequent with the 16 mg/day recommended initial maintenance dose. Table 2: The Most Frequent Adverse Events in the Placebo-Controlled Trial With Dose Escalation Every 4 Weeks Occurring in at Least 5% of Patients Receiving RAZADYNE ® and at Least Twice the Rate on Placebo. Placebo RAZADYNE ® 16 mg/day RAZADYNE ® 24 mg/day Adverse Event N=286 N=279 N=273 Nausea 5% 13% 17% Vomiting 1% 6% 10% Diarrhea 6% 12% 6% Anorexia 3% 7% 9% Weight decrease 1% 5% 5% Table 3 : The most common adverse events (adverse events occurring with an incidence of at least 2% with RAZADYNE ® treatment and in which the incidence was greater than with placebo treatment) are listed in Table 3 for four placebo-controlled trials for patients treated with 16 or 24 mg/day of RAZADYNE ® . Table 3: Adverse Events Reported in at Least 2% of Patients With Alzheimer's Disease Administered RAZADYNE ® and at a Frequency Greater Than With Placebo Body System Adverse Event Placebo (N=801) RAZADYNE ® Adverse events in patients treated with 16 or 24 mg/day of RAZADYNE ® in four placebo-controlled trials are included. (N=1040) Body as a whole - general disorders Fatigue 3% 5% Syncope 1% 2% Central & peripheral nervous system disorders Dizziness 6% 9% Headache 5% 8% Tremor 2% 3% Gastrointestinal system disorders Nausea 9% 24% Vomiting 4% 13% Diarrhea 7% 9% Abdominal pain 4% 5% Dyspepsia 2% 5% Heart rate and rhythm disorders Bradycardia 1% 2% Metabolic and nutritional disorders Weight decrease 2% 7% Psychiatric disorders Anorexia 3% 9% Depression 5% 7% Insomnia 4% 5% Somnolence 3% 4% Red blood cell disorders Anemia 2% 3% Respiratory system disorders Rhinitis 3% 4% Urinary system disorders Urinary tract infection 7% 8% Hematuria 2% 3% Adverse events occurring with an incidence of at least 2% in RAZADYNE-treated patients that was either equal to or greater than with placebo treatment were constipation, agitation, confusion, anxiety, hallucination, injury, back pain, peripheral edema, asthenia, chest pain, urinary incontinence, upper respiratory tract infection, bronchitis, coughing, hypertension, fall, and purpura. There were no important differences in adverse event rates related to dose or sex. Therewere too few non-Caucasian patients to assess the effects of race on adverse event rates. No clinically relevant abnormalities in laboratory values were observed. Other Adverse Events Observed During Clinical Trials RAZADYNE ® Tablets were administered to 3055 patients with Alzheimer's disease. A total of 2357 patients received galantamine in placebo-controlled trials and 761 patients with Alzheimer's disease received galantamine 24 mg/day, the maximum recommended maintenance dose. About 1000 patients received galantamine for at least one year and approximately 200 patients received galantamine for two years. To establish the rate of adverse events, data from all patients receiving any dose of galantamine in 8 placebo-controlled trials and 6 open-label extension trials were pooled. The methodology to gather and codify these adverse events was standardized across trials, using WHO terminology. All adverse events occurring in approximately 0.1% are included, except for those already listed elsewhere in labeling, WHO terms too general to be informative, or events unlikely to be drug caused. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; infrequent adverse events - those occurring in 1/100 to 1/1000 patients; rare adverse events - those occurring in fewer than 1/1000 patients. These adverse events are not necessarily related to RAZADYNE ® treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies. Additional adverse events observed in other clinical trials are also included below. Body As a Whole – General Disorders: Frequent: chest pain, asthenia, fever, malaise Cardiovascular System Disorders: Infrequent : postural hypotension, hypotension, dependent edema, cardiac failure, myocardial ischemia or infarction Central & Peripheral Nervous System Disorders: Infrequent : vertigo, hypertonia, convulsions, involuntary muscle contractions, paresthesia, ataxia, hypokinesia, hyperkinesia, apraxia, aphasia, leg cramps, tinnitus, transient ischemic attack or cerebrovascular accident Gastrointestinal System Disorders: Frequent: flatulence; Infrequent: gastritis, melena, dysphagia, rectal hemorrhage, dry mouth, saliva increased, diverticulitis, gastroenteritis, hiccup; Rare: esophageal perforation Heart Rate & Rhythm Disorders: Infrequent: AV block, palpitation, atrial arrhythmias including atrial fibrillation and supraventricular tachycardia, QT prolonged, bundle branch block, T-wave inversion, ventricular tachycardia; Rare: severe bradycardia Metabolic& Nutritional Disorders: Infrequent : hyperglycemia, alkaline phosphatase increased Platelet, Bleeding& Clotting Disorders: Infrequent : purpura, epistaxis, thrombocytopenia Psychiatric Disorders: Infrequent : apathy, paroniria, paranoid reaction, libido increased, delirium; Rare: suicidal ideation, suicide Urinary System Disorders: Frequent : incontinence; Infrequent : hematuria, micturition frequency, cystitis, urinary retention, nocturia, renal calculi Post-Marketing Experience: Other adverse events from post-approval controlled and uncontrolled clinical trials and post-marketing experience observed in patients treated with RAZADYNE ® include: Body as a Whole – General Disorders: dehydration (including rare, severe cases leading to renal insufficiency and renal failure) Psychiatric Disorders: aggression Gastrointestinal System Disorders: upper and lower GI bleeding, stomach discomfort, abdominal discomfort Hepatobiliary Disorders: elevated liver enzymes, hepatitis Metabolic& Nutritional Disorders: hypokalemia Nervous System Disorders: lethargy, dysgeusia, hypersomnia Eye disorders: vision blurred These adverse events may or may not be causally related to the drug.