PMID- 27398293
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220410
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 3
IP  - 2
DP  - 2016 Jun
TI  - Drug-Induced Subacute Cutaneous Lupus Erythematosus Associated with Proton Pump 
      Inhibitors.
PG  - 145-154
AB  - Subacute cutaneous lupus erythematosus (SCLE) is an autoimmune disease that may 
      be induced by proton pump inhibitors (PPIs) in at-risk populations. The US FDA 
      does not recognize SCLE as an adverse event associated with PPIs. We queried the 
      FDA Adverse Event Reporting System database, which contains adverse event case 
      reports submitted by the public as well as by industry, and analyzed the data to 
      quantify passive pharmacovigilance signals for SCLE associated with PPIs. A 
      disproportionality analysis of the signals yielded a significant association 
      between SCLE and PPIs. Discontinuation of PPI resulted in remission, with PPI 
      re-challenge causing SCLE to reoccur. A follow-up analysis also yielded a 
      significant association between SCLE and H2 receptor antagonists. We conducted a 
      brief literature survey of published case reports and studies to discern the 
      validity of PPI-induced SCLE signals. Healthcare prescribers and patients should 
      be made aware that SCLE can be induced by PPIs. In such cases, PPIs should be 
      discontinued and alternative clinical treatment sought. Regulatory bodies such as 
      the FDA should incorporate the adverse reaction in PPI prescription labels.
FAU - Aggarwal, Nitish
AU  - Aggarwal N
AD  - The Ohio State University Wexner Medical Center, 410 W 10th Ave, Columbus, OH 
      43210 USA.
LA  - eng
PT  - Journal Article
DEP - 20160329
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC4914530
COIS- Compliance with Ethical Standards Ethical approval Ethical approval was not 
      required. Conflict of interest Nitish Aggarwal has no conflicts of interest to 
      declare. Funding No sources of funding were used to assist in the preparation of 
      this study.
EDAT- 2016/07/12 06:00
MHDA- 2016/07/12 06:01
PMCR- 2016/03/29
CRDT- 2016/07/12 06:00
PHST- 2016/07/12 06:00 [entrez]
PHST- 2016/07/12 06:00 [pubmed]
PHST- 2016/07/12 06:01 [medline]
PHST- 2016/03/29 00:00 [pmc-release]
AID - 67 [pii]
AID - 10.1007/s40801-016-0067-4 [doi]
PST - epublish
SO  - Drugs Real World Outcomes. 2016 Mar 29;3(2):145-154. doi: 
      10.1007/s40801-016-0067-4. eCollection 2016 Jun.