title: Isotretinoin and the risk of cardiovascular, cerebrovascular and thromboembolic disorders.
abstract: BACKGROUND
  Case reports suggest that isotretinoin use is associated with an increased risk of cardiovascular disorders; however, the clinical significance has not been determined.
  
  
  OBJECTIVE
  To determine whether isotretinoin increases the risk of cardiovascular outcomes.
  
  
  METHODS
  A case crossover study was performed among subjects who filled ≥1 isotretinoin prescription during 1984-2003. Cases were defined as those with a first-ever diagnosis or hospitalization for acute myocardial infarction (MI), stroke, phlebitis/thrombophlebitis, pulmonary embolism (PE) or thrombosis. Exposure to isotretinoin in a 5-month hazard period immediately prior to the index date (calendar date of the diagnosis or hospitalization for the study outcomes) was compared to a 5-month control period. Odds ratios (ORs) along with 95% confidence intervals (CIs) were estimated using conditional logistic regression.
  
  
  RESULTS
  Of 30,496 isotretinoin users identified, 872 (3%) cases met the inclusion criteria; 381 (43.7%) had a stroke, 268 (30.7%) phlebitis/thrombophlebitis, 133 (15.3%) MI, 61 (7.0%) PE and 29 (3.3%) thrombosis. When stratified according to type of outcome, ORs were 0.75 (95% CI: 0.38-1.47), 1.31 (95% CI: 0.64-2.69) and 2.00 (95% CI: 0.50-8.00) for stroke, phlebitis/thrombophlebitis and MI, respectively.
  
  
  CONCLUSIONS
  No statistically significant association was found between isotretinoin and cardiovascular, cerebrovascular and thromboembolic outcomes.
authors.affiliation: Faculty of Pharmacy, University of Montreal, Montreal, Que., Canada. anick.berard@umontreal.ca
authors.forename: Anick
authors.initials: A
authors.lastname: Bérard
authors.forename: Laurent
authors.initials: L
authors.lastname: Azoulay
authors.forename: Hamid Reza
authors.initials: HR
authors.lastname: Nakhai-Pour
authors.forename: Krystel
authors.initials: K
authors.lastname: Moussally
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D016022:Case-Control Studies; D002561:Cerebrovascular Disorders / Q000139:chemically induced*; D018592:Cross-Over Studies; D003879:Dermatologic Agents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015474:Isotretinoin / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012306:Risk; D013923:Thromboembolism / Q000139:chemically induced*; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D015474:Isotretinoin