Dermatology World May 2012 Supplement : Page 16

BETTER PRACTICES, SAME RESULTS? As a result, the FDA began e orts to ensure safe use in patients of childbearing age while still protect-ing patient access to the vital drug. Following the widely perceived failure of the FDA’s original System to Manage Accutane-Related Teratogenicity (SMART) program, the FDA instituted the iPLEDGE program in March 2006. Under the program, patients and their physicians and pharmacists were required to iPLEDGE AND PATIENT REGISTRATION Controversial at the outset, the iPLEDGE program, with its strict prescribing windows, blackout periods, and mandatory registration for both female and male patients, has been called “a logistical nightmare,” with loopholes “sealed with a wall of bureaucratic red tape,” by Danbury, Conn., physician Graeme Lipper, MD, in an isotretinoin column published on MedScape . Yet over the years, some of the program’s rougher edges have been smoothed away thanks to and patient advocacy. It’s a great drug. We need to have it available physician According to dermatologist for the patients that need it. Mary Maloney, MD, who chairs the American Academy of Der-matology Association’s Regula-tory Policy Committee, there is register on the FDA’s iPLEDGE website and follow still room for the program to improve, becoming more a set of regulations designed to minimize the risk of consumer-friendly, though it’s doubtful that this will fetal exposure. More than six years after the program’s happen soon. implementation, dermatologists say the program has “One of the things that I question is the validity of set a number of good prescribing practices while para-continuing to register men. And I think that there is doxically failing to signi cantly decrease the annual absolutely no question about the fact that there’s no number of fetal exposures. ISOTRETINOIN AND IBD During isotretinoin’s prolonged term in the public eye, some in medicine and the media began to question whether there was a link between the drug and the development or exacerbation of inflammatory bowel disease (IBD). After Roche Holding ceased production of Accutane in 2009, a Los Angeles Times headline read “New study may deal final blow to acne drug Accutane.” Yet a number of dermatologists and researchers found no link with IBD following population-based case control studies. Researchers at the University of Manitoba found that isotretinoin use was neither more nor less prevalent in patients suffering from IBD than in the general population. A June 2011 article by Catalin Mihai Popescu, MD, PhD, and Raluca Popescu, MD, PhD, in Archives of Dermatology (2011:147(6);724-729) concluded that there was insufficient evidence to confirm or refute a causal association between isotretinoin and IBD. Dermatologist Elliot Mostow, MD, who prescribes isotretinoin to patients, and who offered comment on the Archives article (2011:147(6);729-730), said that he makes patients aware of all the issues linked to the drug, and stresses that the benefits outweigh the potential side effects. “I have a discussion with my patients who are contemplating isotretinoin that goes beyond iPLEDGE to try to include as many potential areas of side effects that they might read about elsewhere as possible,” Dr. Mostow said. “I want them to know that I am aware of the issues, some that can be proven, some that cannot, and am still willing to prescribe the medication because I believe that the benefits outweigh the risks.” Dr. Mostow acknowledges that especially in patients with a family history of IBD, it can be an especially difficult decision to accept isotretinoin treatment. 16 SUPPLEMENT TO DERMATOLOGY WORLD // May 2012 www.aad.org

ISOTRETINOIN AND IBD

During isotretinoin’s prolonged term in the public eye, some in medicine and the media began to question whether there was a link between the drug and the development or exacerbation of inflammatory bowel disease (IBD). After Roche Holding ceased production of Accutane in 2009, a Los Angeles Times headline read “New study may deal final blow to acne drug Accutane.” Yet a number of dermatologists and researchers found no link with IBD following population-based case control studies. Researchers at the University of Manitoba found that isotretinoin use was neither more nor less prevalent in patients suffering from IBD than in the general population. A June 2011 article by Catalin Mihai Popescu, MD, PhD, and Raluca Popescu, MD, PhD, in Archives of Dermatology (2011:147(6);724-729) concluded that there was insufficient evidence to confirm or refute a causal association between isotretinoin and IBD. Dermatologist Elliot Mostow, MD, who prescribes isotretinoin to patients, and who offered comment on the Archives article (2011:147(6);729-730), said that he makes patients aware of all the issues linked to the drug, and stresses that the benefits outweigh the potential side effects. “I have a discussion with my patients who are contemplating isotretinoin that goes beyond iPLEDGE to try to include as many potential areas of side effects that they might read about elsewhere as possible,” Dr. Mostow said. “I want them to know that I am aware of the issues, some that can be proven, some that cannot, and am still willing to prescribe the medication because I believe that the benefits outweigh the risks.” Dr. Mostow acknowledges that especially in patients with a family history of IBD, it can be an especially difficult decision to accept isotretinoin treatment. “I reference the article by Popescu in the Archives of Dermatology (and my own comment there), that a critical number is the ‘number needed to treat’ of 2977 (I say 2900 generally), meaning we need to treat 2977 people to get one case of ulcerative colitis,” Dr. Mostow said. “I use a line I borrowed from the epidemiologist David Savitz, PhD, stating that the one thing we know for sure is that this product will not prevent or cure any of the side effects that are reported in the literature. It can be a tough decision, and I acknowledge that with parents and patients. All of this being said, most people appreciate the honest approach and many decide to proceed.” Aware of the litigious nature of isotretinoin treatment, Dr. Mostow has patients or their parents sign an additional form outlining each of the potential side effects that he discusses with patients, and takes extra time to address each of the concerns that patients may have. In all, Dr. Mostow said, the vast majority of patients are thankful that isotretinoin is available as a means of treatment. That, he said, is the most consistent side effect of isotretinoin in his office.

Previous Page Next Page

Publication List
Using a screen reader? Click Here