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- Alleged isotretinoin-associated inflammatory bowel disease: Disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System. [JOURNAL ARTICLE]
- J Am Acad Dermatol 2013 May 14.
BACKGROUND:Some studies have purported to link isotretinoin prescribed for acne with the development of inflammatory bowel disease (IBD).
OBJECTIVE:We sought to identify existence of disproportionate attorney-initiated reporting of isotretinoin-associated IBD in the Food and Drug Administration Adverse Event Reporting System (FAERS).
METHODS:A total of 3,338,835 cases (2003-2011) were downloaded from the FAERS. These were queried for IBD cases reported with isotretinoin for a usage indication of acne while recording reporter category. Trends were analyzed over time for reports by attorneys for all medications compared with reports of IBD with isotretinoin. Signal inflation factor was calculated to determine the distortion of pharmacovigilance signals for IBD with isotretinoin.
RESULTS:There were 2214 cases of IBD resulting from isotretinoin. Attorneys reported 1944 (87.8%) cases whereas physicians reported 132 (6.0%) and consumers reported 112 (5.1%) cases (P value < .01). For the entire FAERS, only 87,905 of the total 2,451,314 (3.6%) reports for all drug reactions during the same time period were reported by attorneys (P value < .01). The signal inflation factor for IBD with isotretinoin for attorney-initiated reports was 5.82, signifying a clear distortion.
LIMITATIONS:The accuracy of reports was not ascertained.
CONCLUSIONS:Attorney-initiated reports inflate the pharmacovigilance signal of isotretinoin-associated IBD in the FAERS.
- What's new in pediatric dermatology?: Part II. Treatment. [Journal Article]
- J Am Acad Dermatol 2013 Jun; 68(6):899.e1-899.e11.
The field of pediatric dermatology has been rich in new developments. Part II of this continuing medical education article will focus on new therapeutic modalities for several entities encountered in pediatric dermatology. The treatment of atopic dermatitis, exciting advances in the use of propranolol and other beta-blockers for the use of infantile hemangiomas, the use of rapamycin for vascular anomalies, the use of biologics in children, the central nervous system risks of general anesthesia in young children, side effects in the use of isotretinoin, the treatment of tinea capitis, treatment of herpes simplex infections, and the use of technologies such as texting and social media in medicine will be discussed.
- Isotretinoin and one patient's teary eyes: "please listen or I'll cry". [Journal Article]
- Int J Dermatol 2013 Jun; 52(6):757-8.
- Isotretinoin maintenance therapy for glioblastoma: A retrospective review. [JOURNAL ARTICLE]
- J Oncol Pharm Pract 2013 May 15.
OBJECTIVES:/st>The current standard treatment of glioblastoma includes maximal safe surgical resection, radiation, and temozolomide. Although isotretinoin has been used for maintenance therapy to delay tumor recurrence, this approach has not been proven to be effective. The objectives of the study are to compare the overall survival, progression-free survival and tolerability of isotretinoin maintenance therapy in patients who received isotretinoin maintenance therapy to patients who did not receive this treatment.
METHODS:/st>This study is a retrospective review of adult patients with glioblastoma treated at MD Anderson Cancer Center from 2004 to 2009. Patients who underwent surgical resection, radiation with concurrent temozolomide, and adjuvant treatment with temozolomide were included in the control group, and compared to similarly treated patients who received isotretinoin maintenance following adjuvant temozolomide.
RESULTS:/st>Eighteen patients who received isotretinoin maintenance therapy and 70 control patients were included in the analysis. Progression-free survival was 25.3 months with maintenance therapy versus 8.3 months for those not receiving maintenance (p = 0.04). There was no difference in the 2-year or 3-year overall survival estimates (p = 0.11). The common toxicities of isotretinoin included dermatologic-, metabolic-, and psychiatric-related adverse effects.
CONCLUSIONS:/st>Isotretinoin maintenance therapy was associated with increased progression-free survival, but did not increase the overall survival in this retrospective review. The potential benefit of maintenance therapy should be weighed against toxicities and negative impact on quality of life in this patient population.
- Comparison of the efficacies of intermittent and continuous low-dose isotretinoin regimens in the treatment of moderate acne vulgaris. [JOURNAL ARTICLE]
- Int J Dermatol 2013 May 15.
BACKGROUND:Acne vulgaris is a chronic inflammatory disease that usually requires systemic treatment for severe forms. Isotretinoin is the most effective drug in the treatment of acne vulgaris. In this study, we aimed to compare the efficacies of intermittent and continuous low-dose isotretinoin regimens in the treatment of moderate acne vulgaris.
METHODS:Sixty patients with moderate acne were included. They were divided into two groups to receive either intermittent or continuous low-dose isotretinoin. All patients were followed up monthly during the treatment period and for at least six months after completion of therapy.
RESULTS:There were no statistically significant differences between the two groups regarding improvement rates at the end of treatments. However, reduction rates in mean acne scores at post-treatment controls were in favor of the continuous low-dose group. During the post-treatment follow-up period, three patients in the intermittent group relapsed, while no relapses were observed in the low-dose group. No significant side effects were observed in any groups.
CONCLUSIONS:Both intermittent and continuous low-dose isotretinoin regimens are very well tolerated and effective as classical regimens in the treatment of moderate acne vulgaris. However, a continuous low-dose regimen seems to be slightly superior in terms of patients' compliance to the treatment and lower risk of relapse.
- Evaluation of the Retinoids With Cisplatin and Vincristine in Xenograft Models of Neuroblastoma. [JOURNAL ARTICLE]
- J Pediatr Hematol Oncol 2013 May 9.
Retinoids have been studied for the treatment of children with neuroblastoma for >25 years. Posttransplant administration of isotretinoin is standard of care for children with high-risk neuroblastoma, whereas fenretinide remains investigational. Previous preclinical studies have evaluated the interaction of retinoids and cytotoxic agents with conflicting results. We evaluated the schedule-dependent interaction of the cytotoxic agents, vincristine and cisplatin, with the retinoids, isotretinoin and fenretinide, in xenograft models of neuroblastoma. Concomitant administration of isotretinoin or fenretinide with the cytotoxic agents did not result in any clear potentiation of cytotoxicity.
- Epidemiology of major congenital malformations with specific focus on teratogens. [JOURNAL ARTICLE]
- Curr Drug Saf 2013 May 7.
Background:Major congenital malformations (MCMs) are a significant cause of infant morbidity and mortality and constitute an important societal and economic burden.
Methods:We conducted a literature review to synthesize current evidence on MCMs. Specific objectives were to: 1) summarize internationally reported prevalence of MCMs based on registries and surveillance systems; 2) describe the epidemiology of different MCM types including critical periods and causative factors; 3) to identify the role played by principal known teratogens on the increase in the risk of MCMs; and 4) determine challenges associated with the epidemiologic assessment of potential risk factors for MCMs as well as potential preventive measures.
Results:It is estimated that 7.9 million infants worldwide are born every year with a MCM, yet there is considerable variation in reported rates across countries. This may be attributable to varying definitions arising from heterogeneity among different classes with respect to critical periods for embryogenesis and organogenesis. There is also substantial etiologic heterogeneity among MCMs classes that potentially contribute to challenges in epidemiologic studies. Modifiable factors such as pharmacologic exposures have received considerable attention and a number of drugs have been shown to be teratogenic including folic acid antagonists, angiotensin converting enzyme inhibitors, antidepressants, anticonvulsants, coumarin derivatives and retinoids including isotretinoin.
Conclusion:The majority of MCMs are due to unexplained causes. Other contributing factors include genetics, environmental factors, multifactorial inheritance, maternal-related conditions, and maternal drug or chemical exposure. However, there remains a need to better understand the epidemiology of MCMs when studying drug effect during gestation.
- The Therapeutic Role of Isotretinoin in the Management of Behçet's Disease: A Single-Blinded, Controlled Therapeutic Study. [Journal Article]
- J Drugs Dermatol 2013 Apr 1; 12(4):e68-73.
To evaluate the long-term remission efficacy and safety of isotretinoin in the treatment of Behcet's disease (BD).<br> PATIENTS andThis single-blind, controlled therapeutic study was conducted in the Department of Dermatology and Venereology at Baghdad Teaching Hospital from February 2011 to January 2012. Thirty patients with BD were included in this work. Each patient received isotretinoin 20 mg orally once daily for 3 months. They were assessed at week 2 and then monthly depending on the Clinical Manifestation Index (CMI) and to record any side effects. At week 12, isotretinoin was stopped and patients were given placebo therapy in a form of glucose capsules for another 3 months.<BR>Thirty patients were treated, 14 (46.6%) males and 16 (53.3%) females, with a male to female ratio of 1:1. Their ages ranged from 16 to 64 years (mean +/- standard deviation [SD], 38.4 +/- 10.9 years). During the first 3 months of therapy, the pathergy test, oral pathergy test, and C-reactive protein were significantly minimized. The CMI before isotretinoin therapy ranged between 2 and 8 (mean +/- SD, 4.933 +/- 1.91). After therapy, within the first 14 days, the mean CMI started to decline to a lower level, and it continued to decline significantly until week 12. It then started to increase through week 4 of placebo therapy, but remained statistically significant until the second month of placebo therapy. Isotretinoin therapy also had a statistically significant effect in reducing oral ulcers and skin manifestations.<BR>Isotretinoin is an effective therapeutic and prophylactic drug in the management of BD.<BR><BR> <EM>J Drugs Dermatol.</EM> 2013;12(4):e68-e73.
- Congenital Neuroblastoma in a Neonate With Isotretinoin Embryopathy. [JOURNAL ARTICLE]
- J Pediatr Hematol Oncol 2013 May 3.
We describe a neonate with isotretinoin embryopathy and an incidental finding of congenital neuroblastoma. Diffuse liver metastases led to the decision to provide oncologic therapy followed by tumor resection. Despite the possible need for chronic care related to the comorbidities of the isotretinoin embryopathy and oncologic management, the patient remains disease-free. Because of the uncertain etiology of neuroblastoma, it remains unclear whether exposure to isotretinoin during embryogenesis and fetal development had an oncogenic effect on this patient.
- Evidence-based recommendations for the diagnosis and treatment of pediatric acne. [Journal Article]
- Pediatrics 2013 May.:S163-86.
Acne vulgaris is one of the most common skin conditions in children and adolescents. The presentation, differential diagnosis, and association of acne with systemic pathology differs by age of presentation. Current acknowledged guidelines for the diagnosis and management of pediatric acne are lacking, and there are variations in management across the spectrum of primary and specialty care. The American Acne and Rosacea Society convened a panel of pediatric dermatologists, pediatricians, and dermatologists with expertise in acne to develop recommendations for the management of pediatric acne and evidence-based treatment algorithms.Ten major topic areas in the diagnosis and treatment of pediatric acne were identified. A thorough literature search was performed and articles identified, reviewed, and assessed for evidence grading. Each topic area was assigned to 2 expert reviewers who developed and presented summaries and recommendations for critique and editing. Furthermore, the Strength of Recommendation Taxonomy, including ratings for the strength of recommendation for a body of evidence, was used throughout for the consensus recommendations for the evaluation and management of pediatric acne. Practical evidence-based treatment algorithms also were developed.Recommendations were put forth regarding the classification, diagnosis, evaluation, and management of pediatric acne, based on age and pubertal status. Treatment considerations include the use of over-the-counter products, topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, and isotretinoin. Simplified treatment algorithms and recommendations are presented in detail for adolescent, preadolescent, infantile, and neonatal acne. Other considerations, including psychosocial effects of acne, adherence to treatment regimens, and the role of diet and acne, also are discussed.These expert recommendations by the American Acne and Rosacea Society as reviewed and endorsed by the American Academy of Pediatrics constitute the first detailed, evidence-based clinical guidelines for the management of pediatric acne including issues of special concern when treating pediatric patients.