isotretinoin and Crohn-Disease

Cases of inflammatory bowel disease (IBD) following isotretinoin use have been reported previously, but whether isotretinoin exposure is associated with IBD has been unclear.. The aim was to evaluate whether isotretinoin use is associated with IBD.. We performed a systematic review and searched MEDLINE, Embase, and CENTRAL databases from inception to January 27, 2023 for relevant case-control and cohort studies. Our outcome was the pooled odds ratio (OR) for IBD and its two subtypes (Crohn disease and ulcerative colitis) in relation to isotretinoin exposure. We conducted a random-effects model meta-analysis and a sensitivity analysis by excluding low-quality studies. A subgroup analysis was undertaken by including studies considering antibiotic use. A trial sequential analysis (TSA) was performed to test the robustness of the conclusiveness of our results.. We included eight studies (four case-control and four cohort studies) with a total of 2,522,422 participants. The meta-analysis found no increased odds for IBD among patients receiving isotretinoin (OR 1.01; 95% confidence interval [CI] 0.80-1.27). Nor did the meta-analysis find increased odds for either Crohn disease (OR 0.87; 95% CI 0.65-1.15) or ulcerative colitis (OR 1.27; 95% CI 0.94-1.73) associated with isotretinoin exposure. The sensitivity and subgroup analyses produced similar results. In TSA, the Z-curve reached the futility boundaries when using relative risk reduction thresholds ranging from 5% to 15%.. This meta-analysis with TSA found no evidence of an association of isotretinoin use with IBD. Isotretinoin should not be withheld because of unnecessary concerns for the development of IBD.. CRD42022298886.

Topics: Colitis, Ulcerative; Crohn Disease; Humans; Inflammatory Bowel Diseases; Isotretinoin; Odds Ratio

Isotretinoin is a treatment option for severe nodulocystic acne. However, its use has inconsistently been associated with the development of inflammatory bowel disease (IBD). This meta-analysis aims to elucidate the association between isotretinoin exposure and the risk for IBD.. A comprehensive search of PubMed/MEDLINE, CINAHL, the Cochrane database, and Google Scholar was performed (July 2015). All studies on the development of IBD in patients with or without prior exposure to isotretinoin, along with control participants, were included. Meta-analysis was carried out using the Mantel-Haenszel random effect model to assess the risk for IBD in the context of prior isotretinoin exposure.. In a pooled analysis of six research studies, there was no increased risk of developing IBD in patients exposed to isotretinoin compared with patients not exposed to isotretinoin [odds ratio (OR) 1.08, 95% confidence interval (CI) 0.82, 1.42, P=0.59]. Furthermore, there was no increased risk of developing Crohn's disease (OR 0.98, 95% CI 0.62, 1.55, P=0.93, I(2)=62%) or ulcerative colitis (OR 1.14, 95% CI 0.79, 1.63, P=0.49, I(2)=44%) in patients exposed to isotretinoin compared with those not exposed to the medication.. Isotretinoin exposure is not associated with an increased risk of developing both ulcerative colitis and Crohn's disease.

Topics: Acne Vulgaris; Chi-Square Distribution; Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Humans; Isotretinoin; Odds Ratio; Risk Assessment; Risk Factors

To examine the association between isotretinoin and the risk for inflammatory bowel disease (IBD) among women of reproductive age.. Nested case-control study and meta-analysis.. A US health claims database.. We formed a cohort of women aged 18 to 46 years who had received at least 1 oral contraceptive prescription from May 1, 2001, through December 31, 2009. The IBD cases were required to have 3 health care contacts with documentation of IBD or a single health care contact followed by use of a drug to treat IBD. Twenty controls were selected for each case using incidence-density sampling, matched on age and date of diagnosis.. Risk ratios (RRs) were formed for incident cases of IBD associated with the use of isotretinoin. A subgroup analysis examined the risk for IBD among those diagnosed as having Crohn disease (CD) and ulcerative colitis (UC). A meta-analysis of published and unpublished studies assessing isotretinoin and IBD used a random-effects model to estimate a pooled RR.. In the case-control study, we identified 2159 IBD cases (1056 with UC and 1103 with CD) and matched them with 43 180 controls. Only 10 cases (0.46%) and 191 controls (0.44%) were exposed to isotretinoin. The adjusted RR for IBD was 0.99 (95% CI, 0.52-1.90). The RRs for UC and CD were 1.10 (95% CI, 0.44-2.70) and 0.91 (0.37-2.25), respectively. For the meta-analysis, the pooled RR for IBD for the 5 studies was 0.94 (95% CI, 0.65-1.36).. The results of this study do not suggest an increase in the risk for IBD, including UC or CD, with use of isotretinoin. Because inflammatory acne in children and adolescents carries a high psychological burden, clinicians should not be discouraged from prescribing this drug owing to a putative association with IBD.

Topics: Adolescent; Adult; Case-Control Studies; Colitis, Ulcerative; Crohn Disease; Databases, Factual; Dermatologic Agents; Female; Humans; Incidence; Isotretinoin; Middle Aged; Odds Ratio; United States; Young Adult

Topics: Acne Vulgaris; Adolescent; Adult; Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Female; Humans; Intestinal Mucosa; Irritable Bowel Syndrome; Isotretinoin; Male; Product Surveillance, Postmarketing

Risk of inflammatory bowel disease under isotretinoin is a scope of a long-standing controversy. The burden of isotretinoin-related irritable bowel syndrome has not been investigated.. To evaluate the risk of Crohn's disease, ulcerative colitis (UC), and irritable bowel syndrome in patients with acne starting isotretinoin vs oral antibiotics treatment.. A global population-based retrospective cohort study assigned 2 groups of patients with acne initiating isotretinoin (n = 77,005) and oral antibiotics (n = 77,005). Comprehensive propensity-score matching was conducted.. The lifetime risk of Crohn's disease (hazard ratio [HR], 1.05; 95% CI, 0.89-1.24; P = .583) and UC (HR, 1.13; 95% CI, 0.95-1.34; P = .162) was comparable between study groups, whereas the lifetime risk of irritable bowel syndrome was lower in isotretinoin-prescribed patients (HR, 0.82; 95% CI, 0.76-0.89; P < .001). In time-stratified analysis, isotretinoin-related risk of UC was significantly increased during the first 6 months following drug initiation (HR, 1.93; 95% CI, 1.29-2.88; P = .001), but decreased afterward to level the risk of the comparator group. The absolute risk difference within the first 6 months was clinically marginal (5.0 additional UC cases/10,000 patients starting isotretinoin; 95% CI, 2.5-7.7).. Retrospective data collection.. Isotretinoin does not confer an elevated risk of Crohn's disease, whilst it might be associated with a slight and transient increase in UC risk.

Topics: Acne Vulgaris; Anti-Bacterial Agents; Colitis, Ulcerative; Crohn Disease; Humans; Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Isotretinoin; Retrospective Studies

Data on the risk of inflammatory bowel disease (IBD) among isotretinoin-exposed patients with acne vulgaris (AV) is controversial.. To compare IBD risk in isotretinoin-exposed and unexposed patients with AV.. Retrospective cohort analysis of patients with AV with and without isotretinoin exposure identified using electronic health records. Primary outcomes were 6-month and 1-year IBD incidence.. The crude 6-month IBD incidence was 0.08% (21/27,230) among isotretinoin-exposed patients with AV compared to 0.04% (254/631,089) among those unexposed. The crude 1-year IBD incidence was 0.10% (28/27,230) among isotretinoin exposed patients with AV and 0.08% (477/631,089) among those unexposed. The odds of developing IBD within 6 months were 87% higher among isotretinoin-exposed patients with AV compared to those unexposed (adjusted odds ratio, 1.87; 95% confidence interval [CI], 1.20-2.93), although the absolute difference was small (risk difference, 2.6 more cases per 10,000 patients; 95% CI, 0.7-4.5). There was no significant difference in the odds of developing IBD at 1 year between isotretinoin-exposed and unexposed patients with AV (adjusted odds ratio, 1.40; 95% CI, 0.95-2.05).. Isotretinoin-exposed patients may be more likely to have IBD detected by a health care provider.. IBD incidence among isotretinoin-exposed patients with AV is very low, and the risk appears similar to that for unexposed patients with AV.

Topics: Acne Vulgaris; Adolescent; Adult; Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Female; Humans; Incidence; Isotretinoin; Male; Retrospective Studies; Risk Factors; United States; Young Adult

Topics: Acneiform Eruptions; Adalimumab; Adult; Anti-Inflammatory Agents, Non-Steroidal; Crohn Disease; Dermatologic Agents; Drug Eruptions; Humans; Isotretinoin; Male

Isotretinoin, a drug widely prescribed for severe acne, has been suspected to increase the risk of ulcerative colitis (UC), but data are conflicting. To further examine the association between isotretinoin use and risk for UC and Crohn's disease (CD), we conducted a large nationwide case-control study in France.. We used information from the National Health Insurance system for all French people covered by the general scheme between 1 January 2008 and 31 December 2010, totaling over 50 million individuals (i.e., 76% of the whole French population). All incident claims for UC and CD and all medical drug reimbursements were automatically recorded in the database. For each case, four controls were matched on age, gender, year of enrollment, and follow-up duration. The association between isotretinoin use and UC or CD claim was estimated by conditional logistic regression.. We included 7,593 cases of inflammatory bowel disease (IBD; 3,187 UC, 4,397 CD, and 9 indeterminate colitis) and 30,372 controls; among them, 26 cases (0.3%) (15 UC (0.5%) and 11 CD (0.3%)) and 140 controls (0.4%) were exposed to isotretinoin. Isotretinoin exposure was not associated with an increased risk for UC (odds ratio (OR)=1.36 (95% confidence intervals (CI): 0.76, 2.45)) but was associated with a decreased risk for CD (OR=0.45 (95% CI: 0.24, 0.85)), P value for homogeneity between UC and CD=0.001. Results were similar in analyses restricted to individuals below the age of 40 years, to cases with colonoscopy or intestinal surgery, or when adjusting for other acne treatments.. In this population-based case-control study, isotretinoin use was not associated with increased UC risk but was associated with a decreased CD risk. This study provides reassuring data for people using isotretinoin.

Topics: Adult; Case-Control Studies; Colitis, Ulcerative; Crohn Disease; Databases, Factual; Dermatologic Agents; Female; France; Humans; Isotretinoin; Logistic Models; Male; Middle Aged; Odds Ratio; Risk Factors

Based on the Food and Drug Administration Adverse Event Reporting System (FAERS), the FDA and Hoffman La Roche issued warnings of a possible causal association between isotretinoin and inflammatory bowel disease. While scientists studied the association, trial lawyers used the courts to award large sums of money to plaintiffs despite the absence of clear scientific evidence of a causal effect. In this Issue of the Journal, a well-designed, large pharmaco-epidemiologic study shows no association. The story of isotretinoin highlights the problems that occur when the FAERS is used in litigation prior to further study and scientific analysis.

Topics: Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Female; Humans; Isotretinoin; Male

Topics: Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Female; Humans; Isotretinoin; Male

Topics: Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Female; Humans; Isotretinoin; Male

Topics: Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Female; Humans; Isotretinoin; Male

Topics: Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Female; Humans; Isotretinoin

Topics: Crohn Disease; Dermatologic Agents; Fusidic Acid; Humans; Isotretinoin; Male; Middle Aged; Prednisone; Rosacea

(1) Isotretinoin, a vitamin A derivative, is marketed as an oral treatment for refractory severe acne. It is known to carry a risk of severe birth defects. The skin tends to become dry and fragile during isotretinoin treatment; (2) Some adverse effects of isotretinoin are caused by damage to the intestinal mucosae. These effects include bloody and mucousy diarrhoea, colitis, ileitis (sometimes severe and necessitating surgery), and aggravation of inflammatory bowel disease such as Crohn's disease; (3) Isotretinoin can affect all mucous membranes, causing multiple disorders of varying severity, affecting: the eyes (conjunctivitis); ear, nose and throat (epistaxis); respiratory tract; gastrointestinal tract (colitis); and urinary tract; (4) Patients must be informed of the risk of mucosal damage and especially of intestinal disorders associated with isotretinoin therapy. Isotretinoin should be borne in mind as a possible cause when a young patient presents with gastrointestinal disorders, and its withdrawal should be envisaged. Isotretinoin is an additional risk factor in patients with a personal or familial history of inflammatory bowel disease.

Topics: Acne Vulgaris; Adolescent; Adult; Colitis; Crohn Disease; Diarrhea; France; Humans; Inflammatory Bowel Diseases; Intestinal Diseases; Intestines; Isotretinoin; Mucous Membrane; United States; Young Adult

Topics: Adult; Crohn Disease; Female; Humans; Inflammatory Bowel Diseases; Isotretinoin

Rosacea fulminans (also known as pyoderma faciale) has been reported to occur in association with Crohn's disease. It is still unclear whether the papulopustules and confluent nodules of rosacea fulminans represent a manifestation of mucocutaneous Crohn's disease or whether this association is a mere coincidence. A 46-year-old woman presented with the spontaneous outbreak of rosacea fulminans and pyostomatitis/pyovulvitis. Complete remission of the mucocutaneous symptoms was achieved with 2 months combination therapy with methylprednisolone, isotretinoin and dapsone. The patient's Crohn's disease, already diagnosed for 3 years, did not flare during this period.

Topics: Anti-Infective Agents; Anti-Inflammatory Agents; Crohn Disease; Dapsone; Dermatologic Agents; Drug Combinations; Female; Humans; Isotretinoin; Methylprednisolone; Middle Aged; Rosacea; Stomatitis; Treatment Outcome; Vulvitis

Topics: Acne Vulgaris; Colitis, Ulcerative; Crohn Disease; Dermatologic Agents; Humans; Isotretinoin; Risk Factors

Topics: Adult; Crohn Disease; Humans; Isotretinoin; Male

A patient with Crohn's disease (CD) subsequently developed the clinical and histological features of hidradenitis suppurative (HS). So far, only five cases with such an association have been reported. Azathioprine (150 mg/d) and methylprednisolone (16 mg/d) for CD combined with isotretinoin (0.7 mg/kg) and periodic administration of antibiotics for HS were used. The treatment was satisfactory, and the patient is now in clinical remission for both diseases.

Topics: Adult; Anti-Bacterial Agents; Azathioprine; Crohn Disease; Drug Therapy, Combination; Hidradenitis Suppurativa; Humans; Isotretinoin; Male; Methylprednisolone

Four patients with inflammatory bowel disease and severe cystic acne were treated with isotretinoin. Two patients had a successful course of treatment without any gastrointestinal side-effects. One patient had two episodes of profuse rectal bleeding that were probably related to pre-existing haemorrhoids. The fourth patient had a flare-up of his Crohn's disease after starting isotretinoin.

Topics: Acne Vulgaris; Adolescent; Adult; Crohn Disease; Gastrointestinal Hemorrhage; Hemorrhoids; Humans; Inflammatory Bowel Diseases; Isotretinoin; Male; Rectal Diseases