isotretinoin and Eye-Diseases

Despite many years of clinical use of isotretinoin, a comprehensive review of evidence for isotretinoin therapy in patients with acne is lacking. We searched MEDLINE, Embase, Cochrane Central, relevant web pages and bibliographies for randomized controlled trials in acne evaluating isotretinoin vs. control (placebo or other therapy). Data were extracted and summarized descriptively. Eleven trials were identified (total 760 patients randomized), containing mostly men. Mean treatment ages ranged from 18 to 47·9 years and participants generally had moderate-to-severe acne. Across all trials, isotretinoin therapy reduced acne lesion counts by a clinically relevant amount, and always by a greater amount than control, which was either placebo (two studies), oral antibiotics (seven studies) or other control (two studies). Across trials with an overall low risk of bias, two of three demonstrated statistically significant differences between isotretinoin and control. The frequency of adverse events was twice as high with isotretinoin (751 events) than with control (388 events). More than half of all adverse events were dermatological and related to dryness. Adverse events from isotretinoin causing participant withdrawal from trials (12 patients) included Stevens-Johnson syndrome, cheilitis, xerosis, acne flare, photophobia, elevated liver enzymes, decreased appetite, headaches and depressed mood. This review suggests that isotretinoin is effective in reducing acne lesion counts, but adverse events are common. This study was registered with PROSPERO number CRD42015025080.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Anti-Bacterial Agents; Dermatologic Agents; Drug Eruptions; Eye Diseases; Female; Gastrointestinal Diseases; Humans; Isotretinoin; Male; Mental Disorders; Middle Aged; Otorhinolaryngologic Diseases; Treatment Outcome; Young Adult

Rosacea is a chronic facial inflammatory dermatosis characterized by background facial erythema and flushing and may be accompanied by inflammatory papules and pustules, cutaneous fibrosis and hyperplasia known as phyma, and ocular involvement. These features can have adverse impact on quality of life, and ocular involvement can lead to visual dysfunction. The past decade has witnessed increased research into pathogenic pathways involved in rosacea and the introduction of novel treatment innovations. The objective of these guidelines is to offer evidence-based recommendations to assist Canadian health care providers in the diagnosis and management of rosacea. These guidelines were developed by an expert panel of Canadian dermatologists taking into consideration the balance of desirable and undesirable outcomes, the quality of supporting evidence, the values and preferences of patients, and the costs of treatment. The 2015 Cochrane review "Interventions in Rosacea" was used as a source of clinical trial evidence on which to base the recommendations.

Topics: Anti-Infective Agents; Consensus; Dermatologic Agents; Dicarboxylic Acids; Doxycycline; Eye Diseases; Humans; Intense Pulsed Light Therapy; Isotretinoin; Ivermectin; Laser Therapy; Metronidazole; Outliers, DRG; Practice Guidelines as Topic; Rosacea; Tetracycline

Based on the review of the medical publications, this article summarizes the main advances in the field of pediatric dermatology which occurred during the last year. The main results concern psoriasis, atopic dermatitis, acne and hemangiomas. A particular attention was given to genodermatoses.

Topics: Attention; Child; Depression; Dermatologic Agents; Dermatology; Etanercept; Eye Diseases; Humans; Immunoglobulin G; Immunosuppressive Agents; Isotretinoin; Mutation; Propranolol; Proto-Oncogene Proteins c-akt; Receptors, Tumor Necrosis Factor; Severity of Illness Index; Skin Diseases; Skin Neoplasms; Vasodilator Agents; Vitamin D

Isotretinoin is used for severe recalcitrant nodular acne and has a variety of associated ocular side effects. This review classifies these ocular side effects according to World Health Organization (WHO) criteria and reviews the existing literature as well as 2449 spontaneous case reports collected from around the world. Ocular sicca, decreased dark adaptation and intracranial hypertension are identified as "certain" side effects from isotretinoin and clinicians are provided guidelines for care and follow-up.

Topics: Adverse Drug Reaction Reporting Systems; Eye Diseases; Humans; Isotretinoin; United States; United States Food and Drug Administration; World Health Organization

Isotretinoin (Accutane, Roche Laboratories Inc, Nutley, NJ) is an important drug, not only for the treatment of severe acne, but also for other diagnoses and in chemoprevention settings. Because the use of isotretinoin is increasing, it is important for physicians to be aware of the adverse events, toxicities, and management issues related to its use. The most important issue is that of congenital defects, which has resulted in new pregnancy prevention policies and programs implemented by the manufacturer. A relatively new concern is that of depression associated with isotretinoin use, also resulting in new policies placed by the manufacturer and the FDA. The most common adverse effects observed during treatment are mucocutaneous and ocular in nature, but laboratory abnormalities and effects in the nervous, musculoskeletal, gastrointestinal, pulmonary, hematologic, and other systems are also described. Additionally, potential drug interactions, follow-up, and toxicity prevention measures are discussed.

Topics: Abnormalities, Drug-Induced; Acne Vulgaris; Cheilitis; Dermatologic Agents; Drug Interactions; Eye Diseases; Humans; Isotretinoin; Liver Function Tests; Mental Disorders; Mouth Mucosa; Musculoskeletal Diseases

Topics: Conjunctivitis; Eye Diseases; Humans; Isotretinoin

Phymas are slowly progressive, disfiguring disorders of the face and ears that represent the end stage of rosacea, a common centrofacial dermatosis. Phymas are probably caused by the sequelae of chronic edema and its related connective tissue and sebaceous gland hypertrophy. Rhinophyma is the commonest among them. Analogous swellings may occur on the chin (gnatophyma), forehead (metophyma), one or both ears (otophyma), and eyelids (blepharophyma). Although rhinophyma has been traditionally associated with alcoholism, there is no evidence to support this association. Four variants of rhinophyma (glandular, fibrous, fibroangiomatous, actinic) can be recognized on clinical and histological basis. The development of skin cancer, such as basal cell carcinoma or squamous cell carcinoma, in rhinophyma appears to be a matter of accidental coincidence of different diseases. Although phymas are best treated surgically, they may be a worthwhile indication for nonsurgical treatment modalities such as systemic isotretinoin. Phymas do not resolve spontaneously.

Topics: Anti-Bacterial Agents; Chronic Disease; Dermatologic Agents; Eye Diseases; Humans; Isotretinoin; Prognosis; Rhinophyma; Rosacea; Sunscreening Agents

To evaluate the ocular surface changes and tear-film functions in patients treated with systemic isotretinoin.. Fifty subjects treated with 0.8 mg/kg oral isotretinoin were enrolled in this prospective clinical trial. All patients underwent a full ophthalmoscopic examination before, during, and after treatment with isotretinoin. Ocular surface changes of the cell content of the surface conjunctival epithelium were evaluated by conjunctival impression cytology and tear-film functions using the Schirmer test, anesthetized Schirmer test, tear breakup time, and rose bengal staining. Subjective ocular complaints were scored with an Ocular Surface Disease Index questionnaire.. There were no significant differences observed in average Schirmer test scores for patients before, during, or after isotretinoin treatment. Mean anesthetized Schirmer test scores and tear breakup time decreased significantly during treatment (P < 0.001). Mean impression cytology scores, Ocular Surface Disease Index scores, and rose bengal staining scores increased significantly during treatment (P < 0.05, P < 0.001 and P < 0.001, respectively). Blepharitis was seen in 36% of patients. All abnormal findings disappeared 1 month after the cessation of treatment.. Conjunctival epithelial cells, tear basal secretion, and tear quality are markedly affected in patients during systemic treatment with isotretinoin (0.8 mg/kg). Ocular adverse effects of isotretinoin are generally not serious and are reversible after discontinuation.

Topics: Acne Vulgaris; Administration, Oral; Adolescent; Adult; Blepharitis; Conjunctiva; Dermatologic Agents; Epithelial Cells; Eye; Eye Diseases; Female; Follow-Up Studies; Humans; Incidence; Isotretinoin; Male; Tears; Young Adult

To evaluate ocular side effects associated with systemic isotretinoin histopathologically.. In this multicenter study, a total of 15 male and 15 female rats were randomly divided into 3 equal groups according to the oral dose of isotretinoin they were administered: 0 mg/kg/d (group A), 7.5 mg/kg/d (group B), and 15 mg/kg/d (group C). Biopsy specimens were taken from the globe conjunctiva, cornea, and eyelid conjunctiva. Expression levels of human beta-defensin-1, human beta-defensin-2, toll-like receptor (TLR)-2, and TLR-4 were evaluated by immunohistochemical methods.. The number of goblet cells in eyelid conjunctiva was significantly lower in group B than that in group A and group C (P = 0.002). The sizes of meibomian gland acini were significantly smaller in group B and group C than those in group A (P < 0.001). Fibrosis of eyelid conjunctiva was significantly higher in group C and group B than that in group A (P = 0.002). The levels of staining of TLR-4 in the cornea with group B were significantly lower compared with group C (P = 0.035).. Our study suggests that isotretinoin in the early period affects eyelid conjunctiva and meibomian glands without affecting the globe conjunctiva and cornea. Occurrence of the initial symptoms of isotretinoin on the eyelids, especially on the meibomian glands, suggests that the symptoms of patients occur because of evaporative dry eye.

Topics: Administration, Oral; Animals; Biopsy; Conjunctiva; Cornea; Dermatologic Agents; Disease Models, Animal; Eye Diseases; Female; Immunohistochemistry; Isotretinoin; Male; Meibomian Glands; Rats; Rats, Wistar

Isotretinoin is a vitamin A derivative used for serious acne that is refractory to other modes of treatment. The most common side effects include dryness of the skin and mucous membranes. Itching as a result of neurological, hematological and ocular side effects has also been reported. Here, we present a 19-year-old female patient who developed premacular hemorrhage and consequent loss of vision in the left eye after oral use of isotretinoin. To the best of our knowledge, this is the first report of the development of premacular hemorrhage as a result of isotretinoin use.

Topics: Acne Vulgaris; Adult; Blindness; Dermatologic Agents; Eye Diseases; Female; Hemorrhage; Humans; Isotretinoin; Young Adult

To examine whether isotretinoin therapy could result in deleterious ocular effects, as previously described in case report studies.. Retrospective cohort study.. The study was conducted using the electronic medical databases of a large health maintenance organization in Israel.. The study population consisted of 14 682 adolescents and young adults who were new users of isotretinoin for acne and 2 age- and sex-matched comparison groups (isotretinoin-naive patients with acne and acne-free patients).. Ocular adverse effects (AEs) or purchases of ophthalmic medications within 1 year after the first dispensed isotretinoin prescription.. In total, 13.8% of the isotretinoin group experienced ocular AEs vs 9.6% of the isotretinoin-naive group and 7.1% of the acne-free group. During a 1-year follow-up period, the isotretinoin group had significantly higher risk for any ocular AEs (hazard ratio, 1.70; P.001) compared with the acne-free group. No such increased risk was observed for the isotretinoin-naive group. The isotretinoin group had higher relative risks for inflammatory and structural AEs.. Isotretinoin use may be associated with short-term ocular events, especially conjunctivitis, underscoring the importance of educating patients and caregivers about these potentially important AEs of the therapy.

Topics: Acne Vulgaris; Adolescent; Case-Control Studies; Cohort Studies; Conjunctivitis; Databases, Factual; Dermatologic Agents; Eye Diseases; Follow-Up Studies; Health Maintenance Organizations; Humans; Isotretinoin; Israel; Male; Patient Education as Topic; Proportional Hazards Models; Retrospective Studies; Risk; Young Adult

Current concerns about persistent visual abnormalities after the use of isotretinoin may lead the Federal Aviation Administration to further restrict its use in pilots or future pilots.

Topics: Accidents, Aviation; Acne Vulgaris; Adverse Drug Reaction Reporting Systems; Aviation; Dose-Response Relationship, Drug; Eye Diseases; Humans; Isotretinoin; Risk Assessment; United States; Vision, Low; Visual Acuity

Isotretinoin can cause a wide variety of ophthalmological adverse effects.

Topics: Anti-Infective Agents, Local; Eye Diseases; Humans; Isotretinoin

Topics: Eye Diseases; Histiocytosis, Sinus; Humans; Isotretinoin; Laryngeal Diseases; Male; Middle Aged; Skin Diseases

To evaluate reported ocular side effects associated with isotretinoin usage.. One thousand seven hundred forty-one case reports received from spontaneous reporting systems, data from the Drug Safety Section of Roche Pharmaceuticals, and the world's literature were evaluated using the World Health Organization Causality Assessment Guide of Suspected Adverse Reactions.. Thirty-eight different signs or symptoms of ocular abnormalities associated with isotretinoin usage have been classified as "certain," "probable/likely," "possible," "unlikely," or "conditional/unclassifiable.". Adverse ocular side effects secondary to isotretinoin that are "certain" include abnormal meibomian gland secretion, blepharoconjunctivitis, corneal opacities, decreased dark adaptation, decreased tolerance to contact lens, decreased vision, increased tear osmolarity, keratitis, meibomian gland atrophy, myopia, ocular discomfort, ocular sicca, photophobia, and teratogenic ocular abnormalities. Those that are "probable/likely" are decreased color vision (reversible) and permanent loss of dark adaptation. Those that have a "possible" association include permanent keratoconjunctivitis sicca. Suggested guidelines for ocular examination for patients on isotretinoin are given.

Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Eye Diseases; Female; Humans; Isotretinoin; Male; Product Surveillance, Postmarketing

Isotretinoin (13-cis-retinoic acid) is commonly used for the treatment of acne vulgaris. We included 55 patients in this prospective study, and inspected them before, while and after therapy with isotretinoin regarding ocular side effects. Careful slit-lamp inspection, measurement of break-up-time and Schirmer-test and microbiological investigations of the conjunctival flora were performed. While staphylococcus aureus was cultured from the conjunctival sac before application of isotretinoin in 7.3%, this percentage increased to 61.8% during therapy. A pathological decrease of break-up-time was realized in 69.1% of the cases, the development of blepharitis in 40%. But in spite of the alteration of conjunctival flora, bacterial conjunctivitis developed in just 7.3% of the cases. However, only 34.5% of the patients showed symptoms of a conjunctivitis sicca, in spite of the impressive diminution of break-up-time in so many cases. All ocular side effects of isotretinoin were treatable and disappeared completely within 1 month after stopping therapy.

Topics: Acne Vulgaris; Adult; Bacterial Infections; Blepharitis; Conjunctiva; Conjunctivitis; Eye Diseases; Female; Humans; Isotretinoin; Male; Staphylococcus aureus; Tears

Isotretinoin (Accutane Capsules) is a synthetic vitamin A compound used for treatment of recalcitrant cystic acne. It has numerous ocular toxic side effects which include anterior segment inflammation, dry eye syndrome, contact lens intolerance, altered refraction, photosensitivity, and reduced night vision. Eye care practitioners should be aware of these potential side effects and be prepared to communicate with the prescribing physician if side effects present.

Topics: Anterior Eye Segment; Epithelium; Eye Diseases; Humans; Isotretinoin; Night Blindness; Papilledema; Photosensitivity Disorders; Refraction, Ocular; Reproduction; Retina; Tretinoin; Vitamin A

A total of 261 adverse ocular reactions occurred in 237 patients who received isotretinoin, a commonly used drug in the treatment of severe cystic acne. Blepharoconjunctivitis, subjective complaints of dry eyes, blurred vision, contact lens intolerance, and photodermatitis are reversible side effects. More serious ocular adverse reactions include papilledema, pseudotumor cerebri, and white or gray subepithelial corneal opacities; all of these are reversible if the drug is discontinued. Reported cases of decreased dark adaptation are under investigation. Isotretinoin is contraindicated in pregnancy because of the many reported congenital abnormalities after maternal use (including microphthalmos, orbital hypertelorism, and optic nerve hypoplasia).

Topics: Acne Vulgaris; Cataract; Conjunctivitis; Cysts; Eye; Eye Diseases; Eyelid Diseases; Humans; Inflammation; Isotretinoin; Photosensitivity Disorders; Skin Diseases; Tretinoin; Vision Disorders