Posted by Leo on March 29, 2001, at 9:30:41
In reply to Anyone had success on Effexor XR? , posted by jp on October 24, 1999, at 14:59:14
Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor XR
During its premarketing assessment, multiple doses of Effexor XR were administered to 705 patients in phase 3 depression studies and Effexor was administered to 96 patients. During its premarketing assessment, multiple doses of Effexor XR were administered to 476 patients in phase 3 GAD studies. In addition, in the premarketing assessment of Effexor, multiple doses were administered to 2897 patients in phase 2-3 depression studies. The conditions and duration of exposure to venlafaxine in both development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (Effexor only) and outpatient studies, fixed-dose, and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 4174 patients exposed to multiple doses of either formulation of venlafaxine who experienced an event of the type cited on at least one occasion while receiving venlafaxine. All reported events are included except those already listed in Tables 3 and 4 and those events for which a drug cause was remote. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. It is important to emphasize that, although the events reported occurred during treatment with venlafaxine, 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 defined as those occurring on one or more occasions in at least 1/100.patients;
infrequent adverse events are defined as those occurring in 1/100 to 1/1000 patients;
rare events are those occurring in fewer than 1/1000 patients.
Body as a whole - Frequent: chest pain substernal, chills, fever; Infrequent: face edema, intentional injury, malaise, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt; Rare: appendicitis, carcinoma, cellulitis, withdrawal syndrome.
Cardiovascular system - Frequent: migraine, postural hypotension; Infrequent: angina pectoris, arrhythmia, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), syncope, thrombophlebitis; Rare: arteritis, first-degree atrioventricular block, bigeminy, bradycardia, bundle branch block, cerebral ischemia, coronary artery disease, congestive heart failure, heart arrest, mitral valve disorder, mucocutaneous hemorrhage, myocardial infarct, pallor.Digestive system - Frequent: eructation, increased appetite; Infrequent: bruxism, colitis, dysphagia, tongue edema, esophagitis, gastritis, gastroenteritis, gastrointestinal ulcer, gingivitis, glossitis, rectal hemorrhage, hemorrhoids, melena, stomatitis, mouth ulceration; Rare: cheilitis, cholecystitis, cholelithiasis, hematemesis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, ileitis, jaundice, intestinal obstruction, oral moniliasis, proctitis, increased salivation, soft stools, tongue discoloration.
Endocrine system - Rare: goiter, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis.
Hemic and lymphatic system - Frequent: ecchymosis; Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy, lymphocytosis, thrombocythemia, thrombocytopenia; Rare: basophilia, cyanosis, eosinophilia, lymphocytosis.Metabolic and nutritional - Frequent: edema, weight gain; Infrequent: alkaline phosphatase increased, glycosuria, hypercholesteremia, hyperglycemia, hyperuricemia, hypoglycemia, hypokalemia, SGOT increased, thirst; Rare: alcohol intolerance, bilirubinemia, BUN increased, creatinine increased, diabetes mellitus, dehydration, gout, hemochromatosis, hypercalcinuria, hyperkalemia, hyperlipemia, hyperphosphatemia, hyponatremia, hypophosphatemia, hypoproteinemia, SGPT increased, uremia.
Musculoskeletal system - Frequent: arthralgia; Infrequent: arthritis, arthrosis, bone pain, bone spurs, bursitis, leg cramps, myasthenia, tenosynovitis; Rare: pathological fracture, myopathy, osteoporosis, osteosclerosis, rheumatoid arthritis, tendon rupture.Nervous system - Frequent: amnesia, confusion, depersonalization, emotional lability, hypesthesia, vertigo; Infrequent: apathy, ataxia, circumoral paresthesia, CNS stimulation, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy, paranoid reaction, psychosis, seizure, abnormal speech, stupor; Rare: akathisia, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, loss of consciousness, delusions, dementia, dystonia, facial paralysis, abnormal gait, Guillain-Barré syndrome, hypokinesia, neuritis, nystagmus, psychotic depression, reflexes decreased, reflexes increased, suicidal ideation, torticollis.
Respiratory system - Frequent: dyspnea; Infrequent: asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration; Rare: atelectasis, hemoptysis, hypoventilation, hypoxia, pleurisy, pulmonary embolus, sleep apnea.
Skin and appendages - Frequent: rash, pruritus; Infrequent: acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin hypertrophy, maculopapular rash, psoriasis, urticaria; Rare: erythema nodosum, exfoliative dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma, pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin striae.
Special senses - Frequent: abnormality of accommodation, mydriasis, taste perversion; Infrequent: cataract, conjunctivitis, corneal lesion, diplopia, dry eyes, exophthalmos, eye pain, hyperacusis, otitis media, parosmia, photophobia, taste loss, visual field defect; Rare: blepharitis, chromatopsia, conjunctival edema, deafness, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, otitis externa, scleritis, uveitis.
Urogenital system - Frequent: metrorrhagia,* prostatitis,* urination impaired, vaginitis*; Infrequent: albuminuria, amenorrhea,* cystitis, dysuria, hematuria, female lactation,* leukorrhea,* menorrhagia,* nocturia, bladder pain, breast pain, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage*; Rare: abortion,* anuria, breast engorgement, breast enlargement, fibrocystic breast, calcium crystalluria, cervicitis,* ovarian cyst,* prolonged erection,* gynecomastia (male),* hypomenorrhea,* kidney calculus, kidney pain, kidney function abnormal, mastitis, menopause,* pyelonephritis, oliguria, salpingitis,* urolithiasis, uterine hemorrhage,* uterine spasm.*
*Based on the number of men and women as appropriate..Postmarketing Reports
Voluntary reports of other adverse events temporally associated with the use of Effexor (the immediate release form of venlafaxine) that have been received since market introduction and that may have no causal relationship with the use of Effexor include the following;agranulocytosis, anaphylaxis, aplastic anemia, catatonia, congenital anomalies, CPK increased, deep vein thrombophlebitis, delirium, EKG abnormalities (such as atrial fibrillation, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia), epidermal necrosis/Stevens-Johnson Syndrome, erythema multiforme, extrapyramidal symptoms (including tardive dyskinesia), hemorrhage (including eye and gastrointestinal bleeding), hepatic events (including GGT elevation; abnormalities of unspecified liver function tests; liver damage, necrosis, or failure; and fatty liver), involuntary movements, LDH increased, neuroleptic malignant syndrome-like events (including a case of a 10-year-old who may have been taking methylphenidate, was treated and recovered), pancreatitis, panic, prolactin increased, renal failure, serotonin syndrome, shock-like electrical sensations (in some cases, subsequent to the discontinuation of Effexor or tapering of dose), and syndrome of inappropriate antidiuretic hormone secretion (usually in the elderly).
There have been reports of elevated clozapine levels that were temporally associated with adverse events, including seizures, following the addition of venlafaxine. There have been reports of increases in prothrombin time, partial thromboplastin time, or INR when venlafaxine was given to patients receiving warfarin therapy.
poster:Leo
thread:13781
URL: http://www.dr-bob.org/babble/20010327/msgs/57905.html