RESULTS & CONCLUSION
After compilation of available research on the topic, we concluded that there is systematic
misuse of antibiotics in the treatment of acne vulgaris, and call into the question their
placement in current guidelines. Furthermore, the cost to society of the disease itself is
relatively undervalued and unrecognized. We conclude that isotretinoin should be
considered sooner in treatment for the indication of moderate to severe acne vulgaris,
following topical treatment options. We also conclude that the current method of managing
the teratogenicity of isotretinoin (iPLEDGE and birth control), is flawed and requires
revision to address the significant amount of birth defects associated with its use.
OBJECTIVE
Current treatment of acne vulgaris relies heavily on systemic antimicrobial agents. The
American Academy of Dermatology recommends their use in treatment of moderate to
severe inflammatory lesions for a duration of 3 months. Antibiotics should not be used as
a monotherapy or for a duration longer than 3 months, but they frequently are. Side effects
to antimicrobial treatment persist after discontinuation. In many patients, acne is a disorder
in which symptoms typically recur over years. Consequently, identifying a sustainable
treatment regimen is an important component of acne management. Isotretinoin is
extremely efficacious and has long-term benefits after use. It has also been the source of
controversy due to its alleged and real connection to severe side effects and teratogenicity.
The purpose of this review is to evaluate the use of antibiotics and isotretinoin in the
treatment of acne vulgaris.
METHODS
We achieved our objective by performing a literature review. Sources from a variety of
medical and scholarly databases were evaluated. We determined the current role of
antibiotics in the treatment of acne vulgaris to be inappropriate, and identified isotretinoin
as an under-utilized treatment option.
Resilience of the Dominant Human Fecal Microbiota upon Short-
Course Antibiotic Challenge
◼Study Results: 1.2 % of IBD cases used isotretinoin before
IBD diagnosis, which was statistically similar to controls (1.1 %
users). This was also similar to the number of IBD patients who
used isotretinoin after a diagnosis of IBD (1.1 % ).
Disproportionate reporting by attorneys
◼Cases reported to FAERS (2003-2011) queried for IBD +
isotretinoin use.
◼2,214 cases of IBD “resulting from isotretinoin”.
▪Attorneys: 1,944 (87.8%)
▪Physicians: 132 (6.0%)
▪Consumers: 112 (5.1%)
For the entire FAERS, only 87,905 of the total 2,451,354 (3.6%)
reports for all drug reactions during the same time
period were reported by attorneys. The signal
inflation factor for IBD with isotretinoin for attorney
initiated reports was 5.82, signifying a clear distortion.
1. Reduce the use of antibiotics in the treatment
of acne.
2. Address the mental health impact
surrounding untreated acne.
3. Combat the stigma surrounding isotretinoin
and prescribe sooner in appropriate
candidates.
4. Correct the existing weaknesses within the
iPLEDGE program.
Antibiotics In The Treatment of Acne Vulgaris: A Guideline Review Ben Gardner, Grant Jerkovich, Jacob Felckowski, Breannah May, Erika Ernst
University of Iowa College of Pharmacy
Abstract
Abstract Cont.
Antimicrobial Resistance
Mental Health and Acne
Bacterial Transfer of Drug Resistant Genes
Efficaciousness and Side Effects
Litigation Related to Isotretinoin
Cost on Society
Summary of ProposalsIsotretinoin: Link to IBD?
Teratogenicity & iPLEDGE
Side effects that have an occurrence
rate >5%
dry lips, dry skin, back pain, dry eye, arthralgia,
epistaxis, headache, nasopharyngitis,
dermatitis, blood creatine kinase increased,
chelitis, musculoskeletal discomfort, upper
respiratory tract infection, visual acuity reduced
Isotretinoin therapy can result in
clinically significant lesion
reduction.
Cohort analysis shows that
Isotretinoin is a far superior agent
for cystic acne against active
comparators
Isotretinoin is a known
teratogen that causes fetal
defects including soft
tissues, cranial
abnormalities, and mental
retardation iPLEDGE is a restrictive distribution
requiring patients to use 2 forms of birth
control and monthly pregnancy tests.
With iPLEDGE, 3 out of 1000 women
still become pregnant while taking
isotretinoin. In addition to a guideline
recommendation, an update distribution
system is also needed.This was a cross-sectional,
questionnaire-based study to explore
the relationship of suicidal ideation,
mental health problems, and social
functioning to acne severity among
adolescents aged 18–19 years. The
odds ratio is comparing substantial
acne with little or no acne.
“No evidence that use of isotretinoin is associated with an increased risk for
depression, suicide, or other psychiatric disorders.”
Breakdown of Direct Costs
Above is a pie chart comparing the direct cost of
acne to the top 5 skin diseases in the US (US
dollars in billions).
Breakdown of Indirect Costs
Based on the table, patients suffer
from diagnosed depression or
psychosis before exposure to
isotretinoin or antibiotic therapy and
the number of cases actually
decreases after use of either one.
There were more cases of
depression or psychosis with use of
an antibiotic than with isotretinoin.
Similarity of volunteers from D1 to D60, n, number of subjects tested.
Relationship between antibiotic resistance and bacterial fitness.
Table: Association
between the use of
isotretinoin and
inflammatory bowel
disease (IBD) in a
population-based case–
control study in
Manitoba, Canada,
1995–2007