Newsemia

• September 27, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: Adverse Drug Reactions Reported in < 1% of Patients During Clinical Trials Digestive System: Gastritisagranulocytosis and pancytopenia. Nervous System: Depressionanorexiaanuriaaphthous ulcerations of the buccal mucosaaplastic anemiaazotemiabruisingcystitisdiplopia and optic neuritis. Skin and Appendages: Exfoliative dermatitisdisorientationdry mouth and blood in the stool. Increases in alkaline phosphatasedysuriaelectrocardiographic changes and supraventricular tachycardia. Genitourinary Tract: Renal failureflatulencegastrointestinal hemorrhagehematuriahemolytic anemiahemorrhageinsomniainterstitial nephritisjaundice and cholestatic hepatitisLDHlymphadenopathymalaisemastodynia and fever.metallic taste and pancreatitis (see PRECAUTIONS). Cardiovascular: Atrial fibrillationnephrosis and papillary necrosis (see WARNINGS). Hyper sensitivity: Angioedema (angioneurotic edema). Hematologic: Purpuraoliguriapeptic ulcer with/without perforationpersonality changepulmonary edemaseizures and trigeminal neuralgia. Special Senses: Burning tongueSGOTStevens-Johnson Syndrome and alopecia. Miscellaneous: AnaphylaxistachycardiathrombocytopeniaTOXIC EPIDERMAL NECROLYSISurticaria

Updated Date: Sep 27, 2018 EST

• July 27, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: acute kidney failureacute renal failureallergic reactionamylase increasedand eye hemorrhage. Urogenital System Abnormal renal functionand procedural complication. Cardiovascular System Arrhythmiaand respiratory alkalosis. Musculoskeletal System Arthralgiaand rigors. Nervous System Agitationand sinusitis. Skin & Appendages Alopeciaand thrombocytopenia. Metabolic & Nutritional Disorders Acidosisand tremor. Respiratory System Asthmaand vaginal hemorrhage.and vasodilatation (flushing). Digestive System Anorexiaand veno-occlusive liver disease. Hemic & Lymphatic System Anemiaand vesiculobullous rash. Special Senses Conjunctivitisatelectasisatrial fibrillationbone painbradycardiacardiac arrestcardiomegalycell-mediated immunological reactioncellulitisclinical trials: Body as a Whole Abdomen enlargedcoagulation disordercomaconstipationconvulsioncoughdepressiondizzinessdry eyesdry mouth/nosedry skindysesthesiadyspepsiadysphagiaDystoniadysuriaecchymosiseructationface edemafecal incontinenceflatulencefluid overloadgraft-versus-host diseasegum/oral hemorrhagehallucinationshematemesishemoptysishemorrhageHemorrhoidshepatocellular damagehepatomegalyherpes simplexhiccuphyperchloremiahyperkalemiahypermagnesemiahyperphosphatemiahyperventilationhyponatremiahypophosphatemiahypoproteinemiaileusinfluenza-like symptomsinjection site inflammationKidney Failurelactate dehydrogenase increasedLess Common Adverse Events The following adverse events also have been reported in 2% to 10% of AmBisome-treated patients receiving chemotherapy or bone marrow transplantationliver function test abnormallung edemamaculopapular rashmalaisemucositismyalgianeck painnervousnessnonprotein nitrogen (NPN) increasedor who had HIV disease in six comparativeparesthesiapetechiapharyngitispneumoniapostural hypotensionprothrombin decreasedprothrombin increasedpurpurarectal disorderrespiratory failurerespiratory insufficiencyskin discolorationskin disorderskin ulcersomnolencestomatitisthinking abnormalitytoxic nephropathyulcerative stomatitisurinary incontinenceurticariavalvular heart diseasevascular disorder

Updated Date: Jul 27, 2018 EST

• July 25, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: abdominal painand positive test for occult blood in stool. Genitourinary: Urinary frequency (2 to 6%); and rarelyankle edemaanorexiaataxiablurred visionchest painconstipation (2 to 6%); and rarelycoordination disorderdepressiondiarrheadiplopiadry mouthdysarthriaDystoniadysuriaenuresisepileptic seizure. Cardiovascular: Hypotension (0 to 9%). Rare instances of dyspneaeuphoriaexcessive perspirationexcitementhallucinationsheadache (4 to 8%)hematuria. Other: Instances of rashimpotenceinability to ejaculateinsomnia (2 to 7%); and rarelymiosismuscle painmydriasisnocturianystagmuspalpitationparesthesiapruritusrigidityslurred speechstrabismussyncope. Gastrointestinal: Nausea (4 to 12%)taste disorderThe most common is transient drowsiness (10 to 63%). In one controlled study of 175 patientstinnitustransient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 to 15%)tremorurinary retentionvomitingweakness (5 to 15%) and fatigue (2 to 4%). Others reported: Neuropsychiatric: Confusion (1 to 11%)weight gain

Updated Date: Jul 25, 2018 EST

• July 18, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: acarodermatitisacneactive-controlledalanine aminotransferase increasedamenorrheaand anorgasmia Renal and Urinary Disorders: enuresisand Mediastinal Disorders: wheezingand open-label studies of RISPERDAL ® in adults and pediatric patients. Blood and Lymphatic System Disorders: anemiaanorexia Musculoskeletal and Connective Tissue Disorders: joint stiffnessaptyalism General Disorders: edema peripheralatrioventricular block Ear and Labyrinth Disorders: ear painatrioventricular block first degreeblood glucose increasedblood pressure decreasedblood prolactin increasedblunted affectbody temperature decreasedbreast enlargement Respiratorybronchitisbronchopneumoniabundle branch block leftbundle branch block rightcellulitiscerebral ischemiacerebrovascular accidentcerebrovascular disordercheilitischest discomfortchillsconfusional stateconjunctivitiscoordination abnormalcystitisdepressed level of consciousnessdiabetic comadiscomfortdisturbance in attentiondrug withdrawal syndromedry eyedysarthriadyskinesiadysphoniadysuriaear infectionedemaejaculation disorderelectrocardiogram abnormaleosinophil count increasederectile dysfunctioneye dischargeeye infectioneye rollingeye swellingeyelid edemaeyelid margin crustingface edemafecal incontinencefecalomafeeling abnormal Immune System Disorders: drug hypersensitivity Infections and Infestations: pneumoniaflushinggait disturbancegalactorrheagastritisgeneralized edemaglaucomagranulocytopeniaGynecomastiahead titubation Psychiatric Disorders: agitationhematocrit decreasedhemoglobin decreasedhyperkeratosishyperventilationhypoesthesiainfluenzainfluenza-like illnessjoint swellinglacrimation increasedlibido decreasedlip swellinglistlessnesslocalized infectionloss of consciousnessmalaisemenstrual disordermiddle insomniamovement disordermuscular weaknessmusculoskeletal chest painmyalgianasal edema Skin and Subcutaneous Tissue Disorders: erythemaneck painnervousnessneuroleptic malignant syndromeneutropenia Cardiac Disorders: sinus bradycardiaonychomycosisOther Adverse Reactions Observed During the Clinical Trial Evaluation of Risperidone The following additional adverse reactions occurred across all placebo-controlledotitis mediaotitis media chronic Investigations: body temperature increasedperipheral coldnesspharyngitisphotophobiapitting edemapneumonia aspirationpollakiuriapolydipsiaposture abnormalproductive coughprurituspulmonary congestionralesrash erythematousrash generalizedrash maculopapularrash papularrespiratory disorderrespiratory tract congestionrespiratory tract infectionretrograde ejaculationrhabdomyolysis Nervous System Disorders: balance disorderseborrheic dermatitis Vascular Disorders: hypotensionsexual dysfunctionsinus congestionsinus tachycardiaskin discolorationskin disorderskin lesionsleep disordersluggishnessspeech disordersyncopetardive dyskinesiathirstThoracictinnitus Endocrine Disorders: hyperprolactinemia Eye Disorders: ocular hyperemiatonsillitistracheobronchitistransaminases increased Metabolism and Nutrition Disorders: decreased appetitetransient ischemic attackunresponsive to stimuliurinary incontinence Reproductive System and Breast Disorders: menstruation irregularvaginal dischargeviral infectionvisual acuity reduced Gastrointestinal Disorders: dysphagiawhite blood cell count decreased

Updated Date: Jul 18, 2018 EST

• July 17, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactionsanaphylactoid reactionsanemiaaplastic anemiaappetite changes Cardiovascular system - arrhythmiaaseptic meningitis Respiratory - apneaastheniabloatingcerebrovascular accidentcomaconfusionconjunctivitisconstipationcontact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.Closedecreased creatinine clearancedepressiondiarrheadizzinessdream abnormalitiesdrowsinessdry eyesduodenititsdyspepsiadyspnea Skin and appendages - alopeciadysuriaedemaelevated liver enzymesemotional lability hallucinationseosinophiliaepigastric painerythema multiformeesophagitisexfoliative dermatitisflatulencefluid retentiongastric or duodenal ulcer with bleeding and/or perforationgastritisgastrointestinal bleedinggastrointestinal experiences (including abdominal paingingival ulcerglomerulitisglossitisheadacheshearing impairment Urogenital - azotemiaheartburnhematemesishematuriahemolytic anemiahepatitishepatorenal syndromehypertensionhypotensionIn patients taking ibuprofen or other NSAIDsincreased bleeding timeinfectioninsomniainterstitial nephritisjaundiceleukopenialiver failureliver necrosislymphadenopathymalaisemelenamyocardial infarctionnauseanervousnessneutropeniaoliguria/polyuriapalpitationspancreatitis Hemic and lymphatic system - agranulocystosispancytopenia Metabolic and nutritional - hyperglycemia Nervous system - convulsionsparesthesiaphotosensitivitypneumoniaproteinuriaprurituspurpurarashes (including maculopapular) and tinnitus. Additional adverse experiences reported occasionally include: Body as a whole - feverrectal bleeding Hemic and lymphatic system - ecchymosisrenal papillary necrosisrespiratory depressionrhinitis Skin and appendages - angioedemascotomata and/or changes in color vision)sepsis Cardiovascular system - congestive heart failure in patients with marginal cardiac functionsomnolenceStevens-Johnson syndromestomatitissweat Special senses - blurred vision Urogenital system - cystitissyncope Digestive system - dry mouthtachycardiathe most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Abnormal renal functionthrombocytopenia Metabolic and nutritional - weight changes Nervous system - anxietytoxic epidermal necrosistremorstubular necrosis To report SUSPECTED ADVERSE EVENTSurticariavasculitis Digestive system - eructationvertigo Respiratory system - asthmavesiculobullous eruptions Special senses - amblyopia (blurred and/or diminished visionvomitingwhich occur rarely are: Body as a whole - anaphylactic reactions

Updated Date: Jul 17, 2018 EST

• July 13, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: Adverse Drug Reactions Reported in <1% of Patients During Clinical Trials Digestive System—GastritisAGRANULOCYTOSISand alopecia. Miscellaneous—Anaphylaxisand fever.and optic neuritis. Skin and Appendages—Exfoliative dermatitisand pancreatitis (see PRECAUTIONS). Cardiovascular—Atrial fibrillationand pancytopenia. Nervous System—Depressionand papillary necrosis (see WARNINGS). Hypersensitivity—Angioedema (angioneurotic edema). Hematologic—Purpuraand supraventricular tachycardia. Genitourinary Tract—Renal failureand trigeminal neuralgia. Special Senses—Burning tongueanorexiaanuriaaphthous ulcerations of the buccal mucosaaplastic anemiaazotemiablood in the stool. Increases in alkaline phosphatasebruisingcholestatic hepatitiscystitisdiplopiadisorientationdry mouthdysuriaelectrocardiographic changesflatulencegastro- intestinal hemorrhagehematuriahemolytic anemiahemorrhageinsomniainterstitial nephritisjaundiceLDHlymphadenopathymalaisemastodyniametallic tastenephrosisoliguriapeptic ulcer with/without perforationpersonality changepulmonary edemaseizuresSGOTStevens-Johnson syndrometachycardiathrombocytopeniaTOXIC EPIDERMAL NECROLYSISurticaria

Updated Date: Jul 13, 2018 EST

• July 11, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: agitationblurring of vision. Gastrointestinal: Dryness of the mouthCardiovascular: Palpitationchanges in libido.Closeconstipationdiarrheadizzinessdysuriaelevated blood pressure. Central Nervous System: Overstimulationflushingheadacheinsomnianauseapsychotic staterestlessnessstomach pain. Genitourinary: Urinary frequencysweatingtachycardiatremor

Updated Date: Jul 11, 2018 EST