Isotretinoin Monitoring Trends: A National Survey of Dermatologists
June 2017 | Volume 16 | Issue 6 | Original Article | 557 | Copyright © June 2017
Julia G. Hobson MD, Michael J. Cunningham MD, Kendra Lesiak MD MEd, Elizabeth B. Lester MD, Andrew R. Tegeder MD MS, Elizabeth Zeeck MD, Jeremy M. Hugh MD, and Julie H. Lin MD
University of Vermont Medical Center, Division of Dermatology, Burlington, VT
BACKGROUND: Isotretinoin is an effective treatment for nodulocystic acne. Outside of required pregnancy testing, laboratory monitoring suggested by the manufacturers is vague. Dermatologists, therefore, monitor a variety of tests with variable frequency. Despite intense monitoring, the majority of patients do not have gross laboratory abnormalities that warrant changes in management.
OBJECTIVE: To survey US dermatologists regarding laboratory monitoring practices while prescribing isotretinoin.
METHODS: An online survey sent via e-mail to members of the American Academy of Dermatology.
RESULTS: 12,396 surveys were sent with a response rate of ~19%. At baseline >60% of responders check a CBC, LFTs, and a lipid panel. 74% check a monthly lipid panel and LFTs, while 57% check a monthly CBC. 75% report stopping isotretinoin when AST or ALT values reach 3 times normal; 89% report stopping at 4 times normal. When triglycerides reach 4 times normal, 72% stop the medication.
CONCLUSIONS: There is no consensus on isotretinoin monitoring tests and frequency, though the majority of dermatologists surveyed monitor a lipid panel and LFTs.
J Drugs Dermatol. 2017;16(6):557-564.
Acne is a common dermatologic problem affecting the majority of teenagers in the US. A recent population-based study estimated the prevalence of severe acne steadily increases from 1.7% at age 11 to 12.1% by age 17 in US teenagers.1 Severe acne has been associated with multiple co-morbidities, including psychological illnesses, such as depression, anxiety, insomnia, and attention deficit hyperactivity disorder.2 For these patients, treatment may represent much more than a cosmetic outcome. Isotretinoin was approved for the treatment of nodulocystic acne in 1982.3,4 It is currently the only disease-modifying medication available.4,5 Due to its teratogenic effects, isotretinoin use has been rigorously regulated via the iPLEDGE program, since 2006, in the US. It requires female patients to undergo monthly pregnancy tests, monthly patient counseling regarding pregnancy risk, and monthly patient identification of contraceptive methods.6 Unfortunately, the impact of the iPLEDGE program is questionable as pregnancy rates have not statistically decreased since its implementation.6 Most of the adverse effects of isotretinoin are generally tolerable, dose dependent, and reversible, including cheilitis, eczema, fatigue, mood changes, skin fragility, epistaxis, muscle aches, and eye irritation.5 Less frequently reported side effects include elevation of liver aminotransferases (LFTs), lipid abnormalities, hematological abnormalities, infections, alopecia, and headaches.5,7,8 Due to the reported laboratory abnormalities, many clinicians routinely monitor laboratory markers at baseline and regularly throughout treatment. Commonly measured labs include complete blood counts (CBC), LFTs, cholesterol, and triglycerides. Alterations in these laboratory values, however, are rarely significant enough to warrant therapy discontinuation.7,9 Currently, the American Academy of Dermatology (AAD) does not have specific guidelines describing the type and frequency of laboratory monitoring recommended in patients taking short treatment courses of isotretinoin for severe nodulocystic acne. As this medication is widely used throughout the US, we sought to explore how clinicians in our country are using laboratory monitoring for patients on isotretinoin.
A 12-question survey (Figure 1) was designed to examine lab monitoring practices of isotretinoin. In addition to monitoring practices, the survey assessed provider actions when common lab abnormalities arise, such as elevations in triglycerides and LFTs. A pilot survey was sent to all 19 healthcare providers in the division of dermatology at the University of Vermont Medical Center (UVMMC), Burlington, VT. The survey was nalized based on the feedback and responses. Some of the questions were multi-click, to allow for more than one answer. Many of the questions had an “other” option, through which participants could add free text comments or