isotretinoin and Headache

Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formulation of isotretinoin has been shown to be clinically equivalent to standard isotretinoin with improved bioavailability and minimal food effect. The safety profile of the micronized formulation has not been described previously.. The objective of this article is to report the incidence and intensity of adverse events found in a comparative, double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the standard isotretinoin formulation (Accutane).. Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin (n = 300) under fasted conditions or standard isotretinoin (n = 300) under fed conditions. One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of standard isotretinoin in two divided doses with food. Adverse events were monitored during 20 weeks of drug therapy.. The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving standard isotretinoin.. Micronized isotretinoin appears to have a safety profile similar to that of standard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia.

Topics: Acne Vulgaris; Affect; Biological Availability; Depression; Dosage Forms; Double-Blind Method; Drug Administration Schedule; Headache; Humans; Isotretinoin; Lipids; Liver Function Tests; Mucous Membrane; Skin; Tablets; Xerophthalmia

It is generally accepted that the inhibition of sebum excretion has a predictive value for anti-acne activity. Whereas oral 13-cisretinoic acid (13-cis-RA) decreases sebum excretion, it has not been shown so far if oral all-trans-retinoic acid (tretinoin, tRA) does so. The aim of this exploratory study was to investigate the effect of oral tRA on the sebum excretion rate (SER) in young male subjects.. 12 healthy volunteers with a baseline SER above 1.0 microgram/cm2/min were treated with 20 mg/day tRA for 4 weeks. The SER was measured at weeks 2 and 4. Adverse reactions were recorded.. The mean SER varied from 1.56 at baseline to 1.65 at week 2 and to 1.49 micrograms/cm2/min at week 4. Comparison with values obtained in the same subjects previously treated with either 13-cis-RA or 9-cis-retinoic acid indicated that tRA less sebosuppressive. Mucocutaneous reactions and headache were the most frequent side effects of oral tRA.. The lack of effect on the SER suggests that oral tRA would probably be ineffective against acne. The fact that, of the three isomers tested, only 13-cis-RA (which does not bind to nuclear receptors) shows activity may suggest that sebosuppression is not nuclear receptor mediated. We discuss other hypotheses related to pharmacokinetics.

Topics: Acne Vulgaris; Administration, Oral; Adult; Alitretinoin; Drug Eruptions; Facial Dermatoses; Headache; Humans; Isotretinoin; Keratolytic Agents; Lip Diseases; Male; Mucous Membrane; Retinoids; Sebum; Skin; Tretinoin

Topics: Acne Vulgaris; Acute Disease; Adult; Clinical Trials as Topic; Depression; Female; Headache; Humans; Isotretinoin; Male; Middle Aged; Skin Diseases

Purpose/aim: We describe, in detail, the first case of isotretinoin-induced aseptic meningitis. A brief summary of the literature on drug-induced aseptic meningitis (DIAM) is also presented.. A 20-year old female patient with probable (Naranjo adverse reaction probability score of 7) DIAM during treatment with isotretinoin therapy for nodular acne solely, presenting with headache. Pseudotumor cerebri was appropriately ruled-out.. Summary of data altogether lead us suggest that isotretinoin triggered DIAM, possible due to a delayed hypersensitivity mechanism type III or IV.. We highlight a quite uncommon cause of DIAM that may be increasing in frequency due to the current increasing use of isotretinoin against nodular acne.

Topics: Acne Vulgaris; Female; Headache; Humans; Isotretinoin; Meningitis, Aseptic; Young Adult

Isotretinoin, for acne treatment, is associated with high rates of permanent remission. However, at recommended doses of 0.5-1.0 mg/kg/day for 5-6 months [average cumulative dose: 120-150 mg/kg], more than 20% of patients experience a relapse within two years that requires further medical management.. To examine outcomes of high-dose isotretinoin in a cohort with cystic acne, as well as measuring its impact on quality of life (QOL).. A single dermatologist, single institution investigation within an academic tertiary care center in Bronx, NY. Eighty patients with nodulocystic acne, maintained on oral isotretinoin at a dose of 1.3 mg/kg/day or greater, were studied from 2006-2009 while additionally participating in a QOL survey. Main outcome measures included documented events, acne clearance, presence of relapse, and quality of life parameters.. The mean daily dose of isotretinoin was 1.6 mg/kg/day for an average time course of 178 days [cumulative dose: 290 mg/kg]. No side effects or laboratory abnormalities led to discontinuation of treatment. There were no psychiatric symptoms. One-hundred percent (100%) of patients were disease-free upon completion of treatment. During the three-year study period, 10 patients (12.5%) developed a relapse that required an additional course of isotretinoin. Analysis of QOL domains (self-perception, role-social, symptoms) revealed significant improvement following isotretinoin therapy (p = 0.0124, p = 0.0066, p = 0.0265, respectively).. Isotretinoin prescribed at 1.5 mg/kg/day or greater for 5-6 months [cumulative total dose of 290 mg/kg] is safe and effective compared to current standard dosing practices. We propose the use of high-dose isotretinoin (>1.3 mg/kg/day) as a treatment option in severe nodulocystic acne and encourage larger, prospective, multicenter studies into this therapeutic approach.

Topics: Acne Vulgaris; Adolescent; Adult; Child; Dermatologic Agents; Female; Headache; Health Surveys; Humans; Isotretinoin; Liver Function Tests; Male; Middle Aged; Musculoskeletal Pain; Quality of Life; Recurrence; Retrospective Studies; Self Concept; Surveys and Questionnaires; Treatment Outcome; Young Adult

A 16-year-old male started on isotretinoin 80 mg daily for acne developed persistent headache 3 weeks later, with myoclonus and confusion 10 weeks later. During initial hospital assessment his Glasgow Coma Scale score fell acutely to 8 and he required ventilation. Brain imaging and cerebrospinal fluid (CSF) analysis were normal and an electroencephalogram (EEG) showed features of encephalopathy. No cause was found. He was extubated after 24 hours and made a full recovery. This is the first report of a generalized encephalopathy thought likely to be due to isotretinoin.

Topics: Acne Vulgaris; Adolescent; Brain Diseases; Confusion; Dermatologic Agents; Headache; Humans; Isotretinoin; Male; Myoclonus

Physicians make some medical decisions without disclosure to their patients. Nondisclosure is possible because these are silent decisions to refrain from screening, diagnostic or therapeutic interventions. Nondisclosure is ethically permissible when the usual presumption that the patient should be involved in decisions is defeated by considerations of clinical utility or patient emotional and physical well-being. Some silent decisions--not all--are ethically justified by this standard. Justified silent decisions are typically dependent on the physician's professional judgment, experience and knowledge, and are not likely to be changed by patient preferences. We condemn the inappropriate exclusion of the patient from the decision-making process. However, if a test or treatment is unlikely to yield a net benefit, disclosure and discussion are at times unnecessary. Appropriate silent decisions are ethically justified by such considerations as patient benefit or economy of time.

Topics: Acne Vulgaris; Adult; Alzheimer Disease; Contraception Behavior; Cost-Benefit Analysis; Decision Making; Ethics, Clinical; Ethics, Medical; Female; Headache; Humans; Isotretinoin; Male; Mass Screening; Patient Participation; Personal Autonomy; Prostatic Neoplasms; Teratogens; Truth Disclosure

Topics: Depression; Headache; Humans; Isotretinoin

Topics: Adrenal Cortex Hormones; Adult; Antineoplastic Combined Chemotherapy Protocols; Brain; Brain Neoplasms; Carboplatin; Carmustine; Dacarbazine; Disease Progression; Dose Fractionation, Radiation; Ependymoma; Gadolinium; Headache; Humans; Isotretinoin; Magnetic Resonance Imaging; Male; Neoplasm Recurrence, Local; Remission Induction; Tamoxifen; Temozolomide; Tomography, X-Ray Computed; Treatment Outcome

Only mild symptoms of retinoid intoxication--headache, hallucinations and vertebral pain--were observed after ingestion of 800 mg isotretinoin among other drugs. Transaminases and serum lipids were found within normal range five days later. Mucocutaneous effects due to overdosage were absent.

Topics: Adolescent; Hallucinations; Headache; Humans; Isotretinoin; Male; Suicide, Attempted; Tretinoin

Topics: Adult; Drug Administration Schedule; Female; Headache; Humans; Isotretinoin; Male; Menstruation Disturbances; Middle Aged; Neoplasms; Pain; Risk; Tretinoin

We investigated the effect of the synthetic vitamin A derivative isotretinoin (13-cis-retinoic acid) on advanced cancers in 103 patients and on preneoplastic lesions in five patients. Six of 14 patients with squamous cell epithelial cancers had objective regressions of skin or subcutaneous metastases. Three of five patients with preneoplastic lesions had objective responses. The major dose-limiting toxic effects were reversible dermatitis, emotional lability, and headaches. We conclude that the growth of some squamous cell epithelial malignancies can be inhibited by isotretinoin and suggest that other retinoids should be evaluated as antitumor agents.

Topics: Antineoplastic Agents; Carcinoma, Squamous Cell; Drug Eruptions; Drug Evaluation; Emotions; Headache; Humans; Isotretinoin; Neoplasms; Precancerous Conditions; Tretinoin