"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of SORIATANE resemble those of the hypervitaminosis A syndrome.
Adverse Events/Postmarketing Reports
In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of SORIATANE. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders
Aggressive feelings and/or suicidal thoughts have been reported. These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking SORIATANE. Since other factors may have contributed to these events, it is not known if they are related to SORIATANE (see PRECAUTIONS).
Vulvo-vaginitis due to Candida albicans.
Skin and Appendages
Thinning of the skin, skin fragility, and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed. Madarosis and exfoliative dermatitis/erythroderma have been reported (see WARNINGS).
Capillary leak syndrome (see WARNINGS).
During clinical trials with SORIATANE, 513 of 525 (98%) subjects reported a total of 3,545 adverse events. One-hundred sixteen subjects (22%) left trials prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three subjects died. Two of the deaths were not drug-related (pancreatic adenocarcinoma and lung cancer); the other subject died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, SORIATANE was associated with elevations in liver function test results or triglyceride levels and hepatitis.
The tables below list by body system and frequency the adverse events reported during clinical trials of 525 subjects with psoriasis.
Table 3: Adverse Events
Frequently Reported during Clinical Trials Percent of Subjects Reporting (N =
|Body System||> 75%||50% to 75%||25% to 50%||10% to 25%|
|Mucous Membranes||Cheilitis||Rhinitis||Dry mouth Epistaxis|
|Musculoskeletal||Arthralgia Spinal hyperostosis (progression of existing lesions)|
|Skin and Appendages||Alopecia Skin peeling||Dry skin Nail disorder Pruritus||Erythematous rash Hyperesthesia Paresthesia Paronychia Skin atrophy Sticky skin|
Table 4: Adverse Events Less
Frequently Reported during Clinical Trials (Some of Which May Bear No Relationship
to Therapy) Percent of Subjects Reporting (N = 525)
|Body System||1% to 10%||< 1%|
|Body as a Whole||Anorexia Edema Fatigue Hot flashes Increased appetite||Alcohol intolerance Dizziness Fever Influenza-like symptoms||Malaise Moniliasis Muscle weakness Weight increase|
|Cardiovascular||Flushing||Chest pain Cyanosis Increased bleeding time||Intermittent claudication Peripheral ischemia|
|CNS (also see Psychiatric)||Headache Pain||Abnormal gait Migraine Neuritis||Pseudotumor cerebri (intracranial hypertension)|
|Eye Disorders||Abnormal/ blurred vision Blepharitis Conjunctivitis/ irritation Corneal epithelial abnormality||Decreased night vision/night blindness Eye abnormality Eye pain Photophobia||Abnormal lacrimation Chalazion Conjunctival hemorrhage Corneal ulceration Diplopia Ectropion||Itchy eyes and lids Papilledema Recurrent sties Subepithelial corneal lesions|
|Gastrointestinal||Abdominal pain Diarrhea Nausea Tongue disorder||Constipation Dyspepsia Esophagitis Gastritis Gastroenteritis||Glossitis Hemorrhoids Melena Tenesmus Tongue ulceration|
|Liver and Biliary||Hepatic function abnormal Hepatitis Jaundice|
|Mucous Membranes||Gingival bleeding Gingivitis Increased saliva||Stomatitis Thirst Ulcerative stomatitis||Altered saliva Anal disorder Gum hyperplasia||Hemorrhage Pharyngitis|
|Musculoskeletal||Arthritis Arthrosis Back pain Hypertonia Myalgia||Osteodynia Peripheral joint hyperostosis (progression of existing lesions)||Bone disorder Olecranon bursitis Spinal hyperostosis (new lesions) Tendonitis|
|Psychiatric||Depression Insomnia Somnolence||Anxiety Dysphonia Libido decreased Nervousness|
|Reproductive||Atrophic vaginitis Leukorrhea|
|Respiratory||Sinusitis||Coughing Increased sputum Laryngitis|
|Skin and Appendages||Abnormal skin odor Abnormal hair texture Bullous eruption Cold/clammy skin Dermatitis Increased sweating Infection||Psoriasiform rash Purpura Pyogenic granuloma Rash Seborrhea Skin fissures Skin ulceration Sunburn||Acne Breast pain Cyst Eczema Fungal infection Furunculosis Hair discoloration Herpes simplex Hyperkeratosis Hypertrichosis Hypoesthesia Impaired healing Otitis media||Otitis externa Photosensitivity reaction Psoriasis aggravated Scleroderma Skin nodule Skin hypertrophy Skin disorder Skin irritation Sweat gland disorder Urticaria Verrucae|
|Special Senses/ Other||Earache Taste perversion Tinnitus||Ceruminosis Deafness Taste loss|
|Urinary||Abnormal urine Dysuria Penis disorder|
Therapy with SORIATANE induces changes in liver function tests in a significant number of patients. Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 subjects treated with SORIATANE. In most subjects, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In subjects receiving SORIATANE during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% (see WARNINGS). Transient, usually reversible elevations of alkaline phosphatase have been observed.
Table 5 lists the laboratory abnormalities reported during clinical trials.
Table 5: Abnormal Laboratory Test Results Reported
during Clinical Trials Percent of Subjects Reporting
|Body System||50% to 75%||25% to 50%||10% to 25%||1% to 10%|
|Electrolytes||Increased: -Phosphorus -Potassium -Sodium Increased and decreased: -Magnesium||Decreased: -Phosphorus -Potassium -Sodium Increased and decreased: -Calcium -Chloride|
|Hematologic||Increased: -Reticulocytes||Decreased: -Hematocrit -Hemoglobin -WBC Increased: -Haptoglobin -Neutrophils -WBC||Increased: -Bands -Basophils -Eosinophils -Hematocrit -Hemoglobin -Lymphocytes -Monocytes Decreased: -Haptoglobin -Lymphocytes -Neutrophils -Reticulocytes Increased or decreased: -Platelets -RBC|
|Hepatic||Increased: -Cholesterol -LDH -SGOT -SGPT Decreased: -HDL cholesterol||Increased: -Alkaline phosphatase -Direct bilirubin -GGTP||Increased: -Globulin -Total bilirubin -Total protein Increased and decreased: -Serum albumin|
|Miscellaneous||Increased: -Triglycerides||Increased: -CPK -Fasting blood sugar||Decreased: -Fasting blood sugar -High occult blood||Increased and decreased: -Iron|
|Renal||Increased: -Uric acid||Increased: -BUN -Creatinine|
|Urinary||WBC in urine||Acetonuria Hematuria RBC in urine||Glycosuria Proteinuria|
Read the Soriatane (acitretin) Side Effects Center for a complete guide to possible side effects
In a trial of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose-lowering effect of glyburide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the trial with 6 healthy male volunteers in the absence of glyburide did not detect an effect of acitretin on glucose tolerance. Careful supervision of diabetic patients under treatment with SORIATANE is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics and DOSAGE AND ADMINISTRATION).
It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin “minipill” preparations. Microdosed “minipill” progestin preparations are not recommended for use with SORIATANE (see CLINICAL PHARMACOLOGY: Pharmacokinetic Drug Interactions). It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see CONTRAINDICATIONS).
If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.
Vitamin A and Oral Retinoids
Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of hypervitaminosis A.
There appears to be no pharmacokinetic interaction between acitretin and cimetidine, digoxin, or glyburide. Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment.
Some patients receiving retinoids have experienced problems with blood sugar control. In addition, new cases of diabetes have been diagnosed during retinoid therapy, including diabetic ketoacidosis. In diabetics, blood-sugar levels should be monitored very carefully.
In clinical trials, the incidence of hypertriglyceridemia was 66%, hypercholesterolemia was 33%, and that of decreased HDL was 40%. Pretreatment and follow-up measurements should be obtained under fasting conditions. It is recommended that these tests be performed weekly or every other week until the lipid response to SORIATANE has stabilized (see WARNINGS).
Liver Function Tests
Elevations of AST (SGOT), ALT (SGPT), or LDH were experienced by approximately 1 in 3 patients treated with SORIATANE. It is recommended that these tests be performed prior to initiation of therapy with SORIATANE, at 1-to 2-week intervals until stable, and thereafter at intervals as clinically indicated (see CONTRAINDICATIONS and BOXED WARNINGS).
Read the Soriatane Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/11/2015
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