Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States

Pharmacoepidemiol Drug Saf. 2013 Dec;22(12):1251-7. doi: 10.1002/pds.3481. Epub 2013 Aug 3.


Purpose: The major concern associated with isotretinoin treatment is its high teratogenic potential. Therefore, ensuring use of contraception while on therapy is an important strategy for at-risk patients and has been emphasized in all risk management programs. iPledge, the latest and most rigorous isotretinoin program, requires, among other stipulations, monthly assessments of contraceptive use for patients undergoing isotretinoin treatment. The purpose of this study is to evaluate isotretinoin usage patterns and assess concomitant use of isotretinoin and contraceptives before and after iPledge.

Methods: Female patients aged 13-45 years with a new prescription for isotretinoin products during 2004-2008 were identified in the IMS Health longitudinal prescription claims database. Monthly concomitant use of isotretinoin and contraceptives was estimated. Segmented regression analysis of interrupted time series data was used to assess changes in monthly proportion of concomitant use in the 24 months preceding versus following iPledge implementation.

Results: The number of isotretinoin prescriptions decreased after iPledge implementation. A small but significant increase in monthly proportion of patients concomitantly using isotretinoin and contraceptive therapies was observed immediately after iPledge implementation (1.3%, p-value = 0.02), particularly among younger patients (2.5%, p-value < 0.01). No changes in the proportion of concomitancy over time (i.e. slope) between the periods before and after iPledge implementation were observed.

Conclusion: The findings of this pharmacy prescription claims-based study suggest a small increase in concomitant use of isotretinoin and contraceptives coincident with the time of implementation of iPledge, particularly among younger women. Published 2013. This article is a U. S. Government work and is in the public domain in the USA.

Keywords: compliance; contraception; contraceptives; iPledge; isotretinoin; pharmacoepidemiology.

MeSH terms

  • Abnormalities, Drug-Induced / prevention & control*
  • Adolescent
  • Adult
  • Contraceptive Agents / administration & dosage*
  • Contraceptive Agents / therapeutic use
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / therapeutic use
  • Drug Prescriptions / statistics & numerical data
  • Drug Utilization / trends*
  • Female
  • Government Programs
  • Humans
  • Isotretinoin / administration & dosage*
  • Isotretinoin / adverse effects*
  • Isotretinoin / therapeutic use
  • Least-Squares Analysis
  • Middle Aged
  • Risk Management
  • United States
  • Young Adult


  • Contraceptive Agents
  • Dermatologic Agents
  • Isotretinoin