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Issues Relating to the Safety of Accutane
Subcommittee on Oversight and Investigations
Diane S. Berson M.D.
Acne
can be a disfiguring disease. Cystic
acne is a serious condition which can be both painful and unsightly; the
lifelong scarring can be physical as well as emotional.
Isotretinoin, brand name Accutane, is the most effective medication for
the treatment of severe cystic and inflammatory acne. Because of its efficacy and the lack of alternatives for
treating recalcitrant acne, isotretinoin is an extremely valuable drug which
should remain available for dermatologists to prescribe to those patients who
need it. Since the inception of this
drug, dermatologists have been keenly aware of the risk of birth defects in
women who might become pregnant while taking isotretinoin. As a result of strict adherence to guidelines established by
the FDA, the rates of pregnancy in women taking the drug have actually dropped
despite increased use by women of child bearing age. We are dedicated to insuring that even more improvements are
made regarding the rates of pregnancy. The introduction of the SMART
program will take this one step further. we are doing all we can to insure the
success of the SMART program and other programs for generic versions of
isotretinoin. The new regulatory program took
effect on April 10, 2002. Prescribers are required to enroll with the risk
management program in order to continue prescribing this drug. This effort includes yellow Qualification Stickers, patient
information/labeling and patient consent forms. A
vital component of the risk management effort is a survey on female patients'
experience with isotretinoin. Female
patients voluntarily complete survey forms and submit them to enroll in the
survey. The data is analyzed by the
FDA to measure the success and effectiveness of efforts to manage the risk of
pregnancy in female isotretinoin patients.
As dermatologists, we realize that it is imperative that we do what we
can to ensure that the current risk management programs succeed.
We play a vital role in distributing the survey forms to our female
patients and motivating them to enroll in the confidential survey of program
outcomes. Another potential safety issue
regarding Isotretinoin is the possible connection between the use of
Isotretinoin and psychiatric incidences. While
this connection is as yet unproven, dermatologists take these concerns
seriously. Recently a scientific
consensus conference was held to address this issue.
At this conference, stakeholders were informed of the most up-to-date
scientific information on isotretinoin and the psychiatric and pregnancy issues. Some of the conclusions from
the scientific consensus conference include calling for future studies to
examine the possible link between isotretinoin and mood changes or suicide,
drawing upon multidisciplinary teams of dermatologists, adolescent medicine
specialists, psychologists, psychiatrists, pharmacologists, epidemiologists, and
other appropriate professionals. Additionally,
a major effort is needed to expand and integrate basic science research starting
at the molecular level with large-scale epidemiologic studies, and large,
prospective controlled incidence studies. The safety of our patients is
of paramount concern. For many
otherwise healthy adolescents the dermatologist may be the only physician they
see regularly. We (as
dermatologists) thoroughly educate and counsel our patients prior to prescribing
Accutane; we review the potential side effects and risks associated with its
use, and the vigilant need to prevent pregnancy in female patients of
childbearing age. I always frankly
discuss the issue of depression and encourage my patients to inform their
parents or me immediately if they experience any changes in mood or
emotional problems. If I suspect
preexisting depression a referral is made to the appropriate specialist. Accutane has been called a "miracle drug" by many patients (and their families) who have suffered from the pain and embarrassment of acne. It has changed the lives of so many young adults who were forced to avoid interactions with their peers at the very age when social awareness peaks. In the last 15 years I have prescribed Accutane to hundreds of patients. So many individuals are grateful that I was able to offer them this medication which cleared a condition many had suffered with for years. Thank you,
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