The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system - 12/11/11
Abstract |
Background |
Preventing fetal exposure to isotretinoin is widely acknowledged as an important safety issue. The iPLEDGE program is the latest in a series of Food and Drug Administration–mandated risk management programs designed to prevent pregnancies in female patients of childbearing potential (FCBP) taking isotretinoin.
Objective |
We sought to evaluate the effect of iPLEDGE relative to the prior risk management program (system to manage Accutane-related teratogenicity [SMART]) on the risk of isotretinoin fetal exposure in FCBP in a managed care setting.
Methods |
All FCBP at Kaiser Permanente Southern and Northern California who filled at least one prescription for isotretinoin during a 4-year period (March 1, 2004, to February 29, 2008) were included in this retrospective cohort study (n = 8344). Chart review was performed to confirm fetal exposures and outcomes. A Cox proportional hazards model was used to estimate the hazard ratio and 95% confidence intervals.
Results |
There were a total of 29 fetal exposures and 9912 isotretinoin treatment courses. After iPLEDGE was implemented, the unadjusted rate of fetal exposure decreased from 3.11 to 2.67 per 1000 treatment courses (P = .69). The hazard ratio = 0.76 (95% confidence interval 0.36-1.61) for fetal exposures to isotretinoin during treatment courses filled after iPLEDGE implementation compared with SMART.
Limitations |
Limitations include limited generalizability of results, small sample size (n = 29 total documented fetal exposures), and potential uncontrolled confounders.
Conclusion |
Evaluating the impact of iPLEDGE on isotretinoin fetal exposures is important in understanding the full risks and benefits of isotretinoin treatment. We found no evidence that iPLEDGE significantly decreased the risk of fetal exposure in FCBP compared to the SMART program.
Le texte complet de cet article est disponible en PDF.Key words : fetal exposures, iPLEDGE, isotretinoin, risk management program, SMART
Abbreviations used : CI, FCBP, FDA, HR, KPNC, KPSC, RMP, SMART
Plan
Supported by Kaiser Permanente Southern California Regional Research Committee and Kaiser Permanente Northern California Community Benefit. |
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Disclosure: Dr Cheetham has a first-degree relative employed by Allergan (compensated by salary and stock options). Dr McCombs is an investigator for Eli Lilly (compensated by grants), Bristol-Myers Squibb (compensated by grants and honoraria), and Wyeth (compensated by grants). Dr Shin is a consultant for Bristol-Myers Squibb (compensated by grants). Drs Wong, Kass, Yoshinaga, and Sidney; Ms Niu; and Mr Sorel have no conflicts of interest to declare. |
Vol 65 - N° 6
P. 1117-1125 - décembre 2011 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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