title: Adverse and Hypersensitivity Reactions to Prescription Nonsteroidal Anti-Inflammatory Agents in a Large Health Care System.
abstract: BACKGROUND
  Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently used medications in the United States. NSAID use can be limited by adverse drug reactions (ADRs), including hypersensitivity reactions (HSRs).
  
  
  OBJECTIVE
  We aimed to use electronic health record data to determine the incidence and predictors of HSRs to prescription NSAIDs.
  
  
  METHODS
  We performed a retrospective cohort study of all adult outpatients in a large health care system prescribed diclofenac, indomethacin, nabumetone, or piroxicam between January 1, 2004, and September 30, 2012. The primary outcome was an ADR or HSR attributed to the prescribed NSAID within 1 year of prescription, determined from a longitudinal allergy database. We used natural language processing to classify known ADRs as either HSRs or side effects. Multivariable logistic regression models were used to identify independent risk factors for NSAID HSRs.
  
  
  RESULTS
  Of 62,719 patients prescribed NSAIDs, 1,035 (1.7%) had an ADR, of which 189 (18.3%) were HSRs. Multivariable regression analysis identified that patients with prior drug HSR history (odds ratio [OR] 1.8 [95% CI 1.3, 2.5]), female sex (OR 1.8 [95% CI 1.3, 2.4]), autoimmune disease (OR 1.7 [95% CI 1.1, 2.7]), and those prescribed the maximum standing NSAID dose (OR 1.5 [95% CI 1.1, 2.0]) had increased odds of NSAID HSR.
  
  
  CONCLUSIONS
  NSAID therapeutic use can be limited by ADRs; about 1 in 5 NSAID ADRs is an HSR. Both patient and drug factors contribute to HSR risk and are important to guide patient counseling.
authors.affiliation: Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Medical Practice Evaluation Center, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass; Edward P. Lawrence Center for Quality and Safety, Massachusetts General Hospital, Boston, Mass. Electronic address: kblumenthal1@partners.org.
authors.forename: Kimberly G
authors.initials: KG
authors.lastname: Blumenthal
authors.affiliation: Partners HealthCare System, Boston, Mass.
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Lai
authors.affiliation: Biostatistics Center, Massachusetts General Hospital, Boston, Mass.
authors.forename: Mingshu
authors.initials: M
authors.lastname: Huang
authors.affiliation: Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.
authors.forename: Zachary S
authors.initials: ZS
authors.lastname: Wallace
authors.affiliation: Harvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
authors.forename: Paige G
authors.initials: PG
authors.lastname: Wickner
authors.affiliation: Harvard Medical School, Boston, Mass; Partners eCare, Partners HealthCare System, Boston, Mass; Division of General Internal Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
authors.forename: Li
authors.initials: L
authors.lastname: Zhou
mesh_terms: D000328:Adult; D000707:Anaphylaxis; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D003695:Delivery of Health Care; D004342:Drug Hypersensitivity / Q000453:epidemiology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D057286:Electronic Health Records; D005076:Exanthema; D005260:Female; D005767:Gastrointestinal Diseases; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal
keywords: Adverse reaction; Allergy; Drug; Hypersensitivity; Side effect