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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling: Neuropsychiatric symptoms and suicidality [see and Boxed Warning Warnings and Precautions (5.1) Angioedema and hypersensitivity reactions [see ] Warnings and Precautions (5.2) Serious skin reactions [see ] Warnings and Precautions (5.3) Accidental injury [see ] Warnings and Precautions (5.5) In the placebo-controlled studies, the most common adverse events associated with CHANTIX (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. The treatment discontinuation rate due to adverse events in patients dosed with 1 mg twice daily was 12% for CHANTIX, compared to 10% for placebo in studies of three months' treatment. In this group, the discontinuation rates that are higher than placebo for the most common adverse events in CHANTIX-treated patients were as follows: nausea (3% vs. 0.5% for placebo), insomnia (1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo). Smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. Most common adverse reactions (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (e.g., vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. ( ) 6.1 To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During the premarketing development of CHANTIX, over 4500 subjects were exposed to CHANTIX, with over 450 treated for at least 24 weeks and approximately 100 for a year. Most study participants were treated for 12 weeks or less. The most common adverse event associated with CHANTIX treatment is nausea, occurring in 30% of patients treated at the recommended dose, compared with 10% in patients taking a comparable placebo regimen . [see ] Warnings and Precautions (5.6) Table 3 shows the adverse events for CHANTIX and placebo in the 12-week fixed dose studies with titration in the first week [Studies 2 (titrated arm only), 4, and 5]. Adverse events were categorized using the Medical Dictionary for Regulatory Activities (MedDRA, Version 7.1). MedDRA High Level Group Terms (HLGT) reported in ≥ 5% of patients in the CHANTIX 1 mg twice daily dose group, and more commonly than in the placebo group, are listed, along with subordinate Preferred Terms (PT) reported in ≥ 1% of CHANTIX patients (and at least 0.5% more frequent than placebo). Closely related Preferred Terms such as 'Insomnia', 'Initial insomnia', 'Middle insomnia', 'Early morning awakening' were grouped, but individual patients reporting two or more grouped events are only counted once. Table 3: Common Treatment Emergent AEs (%) in the Fixed-Dose, Placebo-Controlled Studies (HLGTs ≥ 5% of patients in the 1 mg BID CHANTIX Group and more commonly than placebo and PT ≥ 1% in the 1 mg BID CHANTIX Group, and 1 mg BID CHANTIX at least 0.5% more than Placebo) SYSTEM ORGAN CLASS High Level Group Term Preferred Term CHANTIX 0.5 mg BID N=129 CHANTIX 1 mg BID N=821 Placebo N=805 GASTROINTESTINAL (GI) GI Signs and Symptoms Nausea 16 30 10 Abdominal Pain Includes PTs Abdominal (pain, pain upper, pain lower, discomfort, tenderness, distension) and Stomach discomfort 5 7 5 Flatulence 9 6 3 Dyspepsia 5 5 3 Vomiting 1 5 2 GI Motility/Defecation Conditions Constipation 5 8 3 Gastroesophageal reflux disease 1 1 0 Salivary Gland Conditions Dry mouth 4 6 4 PSYCHIATRIC DISORDERS Sleep Disorder/Disturbances Insomnia Includes PTs Insomnia/Initial insomnia/Middle insomnia/Early morning awakening 19 18 13 Abnormal dreams 9 13 5 Sleep disorder 2 5 3 Nightmare 2 1 0 NERVOUS SYSTEM Headaches Headache 19 15 13 Neurological Disorders NEC Dysgeusia 8 5 4 Somnolence 3 3 2 Lethargy 2 1 0 GENERAL DISORDERS General Disorders NEC Fatigue/Malaise/Asthenia 4 7 6 RESPIR/THORACIC/MEDIAST Respiratory Disorders NEC Rhinorrhea 0 1 0 Dyspnea 2 1 1 Upper Respiratory Tract Disorder 7 5 4 SKIN/SUBCUTANEOUS TISSUE Epidermal and Dermal Conditions Rash 1 3 2 Pruritis 0 1 1 METABOLISM & NUTRITION Appetite/General Nutrit. Disorders Increased appetite 4 3 2 Decreased appetite/Anorexia 1 2 1 The overall pattern and frequency of adverse events during the longer-term trials was similar to those described in Table 3, though several of the most common events were reported by a greater proportion of patients with long-term use (e.g., nausea was reported in 40% of patients treated with CHANTIX 1 mg twice daily in a one-year study, compared to 8% of placebo-treated patients). Following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening. . anemia, lymphadenopathy. leukocytosis, splenomegaly, thrombocytopenia. Blood and Lymphatic System Disorders Infrequent: Rare: . angina pectoris, arrhythmia, bradycardia, myocardial infarction, palpitations, tachycardia, ventricular extrasystoles. acute coronary syndrome, atrial fibrillation, cardiac flutter, cor pulmonale, coronary artery disease. Cardiac Disorders Infrequent: Rare: . tinnitus, vertigo. deafness, Meniere's disease. Ear and Labyrinth Disorders Infrequent: Rare: . thyroid gland disorders. Endocrine Disorders Infrequent: . conjunctivitis, dry eye, eye irritation, eye pain, vision blurred, visual disturbance. acquired night blindness, blindness transient, cataract subcapsular, ocular vascular disorder, photophobia, vitreous floaters. Eye Disorders Infrequent: Rare: . diarrhea dysphagia, enterocolitis, eructation, esophagitis, gastritis, gastrointestinal hemorrhage, mouth ulceration. gastric ulcer, intestinal obstruction, pancreatitis acute. Gastrointestinal Disorders Frequent: . Infrequent: Rare: . chest pain, edema, influenza-like illness. chest discomfort, chills, pyrexia. General Disorders and Administration Site Conditions Frequent: Infrequent: . gall bladder disorder. Hepatobiliary Disorders Infrequent: . liver function test abnormal, weight increased. electrocardiogram abnormal, muscle enzyme increased, urine analysis abnormal. Investigations Frequent: Infrequent: . diabetes mellitus, hyperlipidemia, hypokalemia. hypoglycemia. Metabolism and Nutrition Disorders Infrequent: Rare: . : arthralgia, back pain, muscle cramp, musculoskeletal pain, myalgia. arthritis, osteoporosis. myositis. Musculoskeletal and Connective Tissue Disorders Frequent Infrequent: Rare: . disturbance in attention, dizziness, sensory disturbance. amnesia, migraine, parosmia, psychomotor hyperactivity, restless legs syndrome, syncope, tremor. balance disorder, cerebrovascular accident, convulsion, dysarthria, facial palsy, mental impairment, multiple sclerosis, nystagmus, psychomotor skills impaired, transient ischemic attack, visual field defect. Nervous System Disorders Frequent: Infrequent: Rare: . disorientation, dissociation, libido decreased, mood swings, thinking abnormal. bradyphrenia, euphoric mood. Psychiatric Disorders Infrequent: Rare: . polyuria. nephrolithiasis, nocturia, urethral syndrome, urine abnormality. R renal failure acute, urinary retention. Renal and Urinary Disorders Frequent: Infrequent: are: . sexual dysfunction. menstrual disorder. erectile dysfunction. Reproductive System and Breast Disorders Rare: Frequent: Infrequent: epistaxis, respiratory disorders. asthma. pleurisy, pulmonary embolism. Respiratory, Thoracic and Mediastinal Disorders. Frequent: Infrequent: Rare: . hyperhidrosis. acne, dry skin, eczema, erythema, psoriasis, urticaria. photosensitivity reaction. Skin and Subcutaneous Tissue Disorders Frequent: Infrequent: Rare: . hot flush. thrombosis. Vascular Disorders Frequent: Infrequent: CHANTIX has also been studied in postmarketing trials including (1) a trial conducted in patients with chronic obstructive pulmonary disease (COPD) (2) a trial conducted in generally healthy patients (similar to those in the premarketing studies) in which they were allowed to select a quit date between days 8 and 35 of treatment ("alternative quit date instruction trial"). (3) a trial conducted in patients with stable cardiovascular disease and (4) a trial conducted in patients with stable schizophrenia or schizoaffective disorder. Adverse events in the trial of patients with COPD and in the alternative quit date instruction trial were quantitatively and qualitatively similar to those observed in premarketing studies. In the trial of patients with stable cardiovascular disease, more types and a greater number of cardiovascular events were reported compared to premarketing studies. Treatment-emergent (on-treatment or 30 days after treatment) cardiovascular events reported with a frequency ≥ 1% in either treatment group in this study were angina pectoris (3.7% and 2.0% for varenicline and placebo, respectively), chest pain (2.5% vs. 2.3%), peripheral edema (2.0% vs. 1.1%), hypertension (1.4% vs. 2.6%), and palpitations (0.6 % vs. 1.1%). Deaths and serious cardiovascular events occurring over the 52 weeks of the study (treatment emergent and non-treatment emergent) were adjudicated by a blinded, independent committee. The following treatment-emergent adjudicated events occurred with a frequency ≥1% in either treatment group: nonfatal MI (1.1% vs. 0.3% for varenicline and placebo, respectively), and hospitalization for angina pectoris (0.6% vs. 1.1%). During non-treatment follow up to 52 weeks, the adjudicated events included need for coronary revascularization (2.0% vs. 0.6%), hospitalization for angina pectoris (1.7% vs. 1.1%), and new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (1.4% vs. 0.6%). Some of the patients requiring coronary revascularization underwent the procedure as part of management of nonfatal MI and hospitalization for angina. Cardiovascular death occurred in 0.3% of patients in the varenicline arm and 0.6% of patients in the placebo arm over the course of the 52-week study. In the trial of patients with stable schizophrenia or schizoaffective disorder, 128 smokers on antipsychotic medication were randomized 2:1 to varenicline (1 mg twice daily) or placebo for 12 weeks with 12-week non-drug follow-up. The most common adverse events in patients taking varenicline were nausea (24% vs. 14.0% on placebo), headache (11% vs. 19% on placebo) and vomiting (11% vs. 9% on placebo). Among reported neuropsychiatric adverse events, insomnia was the only event that occurred in either treatment group in ≥ 5% of subjects at a rate higher in the varenicline group than in placebo (10% vs. 5%). These common and neuropsychiatric adverse events occurred on treatment or within 30 days after the last dose of study drug. There was no consistent worsening of schizophrenia in either treatment group as measured by the Positive and Negative Syndrome Scale. There were no overall changes in extra-pyramidal signs, as measured by the Simpson-Angus Rating Scale. The Columbia-Suicide Severity Rating Scale was administered at baseline and at clinic visits during the treatment and non-treatment follow-up phases. Over half of the patients had a lifetime history of suicidal behavior and/or ideation (62% on varenicline vs. 51% on placebo), but at baseline, no patients in the varenicline group reported suicidal behavior and/or ideation vs. one patient in the placebo group (2%). Suicidal behavior and/or ideation were reported in 11% of the varenicline-treated and 9% of the placebo-treated patients during the treatment phase. During the post-treatment phase, suicidal behavior and/or ideation were reported in 11% of patients in the varenicline group and 5% of patients in the placebo group. Many of the patients reporting suicidal behavior and ideation in the follow-up phase had not reported such experiences in the treatment phase. However, no new suicidal ideation or behavior emerged in either treatment group shortly (within one week) after treatment discontinuation (a phenomenon noted in post-marketing reporting). There were no completed suicides. There was one suicide attempt in a varenicline-treated patient. The limited data available from this single smoking cessation study are not sufficient to allow conclusions to be drawn. 6.2 Postmarketing Experience The following adverse events have been reported during post-approval use of CHANTIX. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been reports of depression, mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide in patients attempting to quit smoking while taking CHANTIX . Smoking cessation with or without treatment is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness. Not all patients had known pre-existing psychiatric illness and not all had discontinued smoking. [see , ] Boxed Warning Warnings and Precautions (5.1) There have been reports of hypersensitivity reactions, including angioedema . [see ] Warnings and Precautions (5.2) There have also been reports of serious skin reactions, including Stevens-Johnson Syndrome and erythema multiforme, in patients taking CHANTIX [see ]. Warnings and Precautions (5.3) There have been reports of myocardial infarction (MI) and cerebrovascular accident (CVA) including ischemic and hemorrhagic events in patients taking Chantix. In the majority of the reported cases, patients had pre-existing cardiovascular disease and/or other risk factors. Although smoking is a risk factor for MI and CVA, based on temporal relationship between medication use and events, a contributory role of varenicline cannot be ruled out.