Acne Medication Unconnected to Inflammatory Bowel Disease
A new study of isotretinoin (originally marketed as Accutane
[Roche]), used in the treatment of severe, recalcitrant acne, found no
increased risk for inflammatory bowel disease (IBD) associated with the
use of the vitamin A derivative, according to a study published in the
February 20 issue of JAMA Dermatology.
The drug, which is the only US Food and Drug
Administration–approved medication for severe acne, is the target of
thousands of lawsuits, including one in which a jury awarded $25 million
to a patient who claimed isotretinoin caused his IBD, according to a
2011 article in Lawyers USA.
Mahyar Etminan, PharmD, assistant professor of
medicine at the University of British Columbia, Vancouver, Canada, and
colleagues compared 2159 women taking combined oral contraceptives who
were diagnosed with IBD with 43,180 women matched by age and index date.
Information about the women (age, 18 - 46 years) was taken from the IMS
LifeLink health plan claims database between May 1, 2001, and December
31, 2009. The case patients included 1056 patients with ulcerative
colitis and 1103 with Crohn's disease.
The researchers found that 10 women (0.46%) in
the case cohort and 191 (0.44%) women in the control cohort had been
exposed to isotretinoin. The adjusted relative risk (RR) for IBD was
0.99 (95% confidence interval [CI], 0.52 - 1.90) for individuals in the
case cohort. In subgroup analyses the adjusted RR for ulcerative colitis
was 1.10 (95% CI, 0.44 - 2.70) and 0.91 (95% CI, 0.37 - 2.25) for
Crohn's disease.
The relative risk was adjusted for disease
states, including asthma, hyperlipidemia, and obesity; indications of
combined oral contraceptive use, such as presence of polycystic ovary
syndrome, acne, or premenstrual disorder; a claim for tobacco cessation
counseling; previous hospitalizations; emergency department visits,
physician office visits in the prior year; use of drugs for IBD,
including nonsteroidal anti-inflammatories and tetracycline
hydrochloride; number of colonoscopies in the previous year; a recent
appendectomy; and geographic region.
The researchers also failed to find an
association between isotretinoin and IBD in a meta-analysis that
included the present study, 3 large published epidemiological studies,
and 1 large unpublished study. Pooled RR for IBD was 0.94 (95% CI, 0.65 -
1.36) in the meta-analysis. The RR for ulcerative colitis was 1.61 (95%
CI, 0.88 - 2.95), and the RR for Crohn's disease was 0.75 (95% CI, 0.46
- 1.24).
Only 1 of the 5 studies in the meta-analysis
showed a strong association between the acne medication and any form of
IBD. That study, by Crockett et al, showed an RR of 4.36 (95% CI, 1.97 -
9.66) for ulcerative colitis.
In an accompanying editorial, Catalin Mihai
Popescu, MD, PhD, from the Carol Davila University of Medicine and
Pharmacy, Bucharest, Romania, and Michael Bigby, MD, from Harvard
Medical School, Boston, Massachusetts, note that Crockett et al did not
adjust for recent antibiotic use and acne severity, which are 2 major
confounding factors.
On the basis of the existing evidence, Dr.
Popescu and Dr. Bigby conclude that physicians should continue to
prescribe isotretinoin for severe, recalcitrant acne.
"The data provided by this study and others did
not suggest that the risk for IBD increases with isotretinoin use.
Dermatologists should counsel patients that the possibility of an
association of isotretinoin use and IBD has been raised but not proved
by the best available evidence. We should not withhold isotretinoin from
patients who need it because of concerns for the development of IBD,"
they write.
One coauthor is employed by the FDA. The other authors and the editorialists have disclosed no relevant financial relationships.
JAMA Dermatol. 2013;149:216-222.
Source: Medscape Today
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