Background
The Adverse Event Reporting System (AERS) is a computerized
information database designed to support the FDA's post-marketing
safety surveillance program for all approved drug and therapeutic
biologic products. The ultimate goal of AERS is to improve the
public health by providing the best available tools for storing
and analyzing safety reports. Reports from AERS are used by FDA
staff in conducting post marketing drug surveillance and compliance
activities and in responding to outside requests for information.
The FDA's Center for Drug Evaluation and Research closely evaluates
drug safety once drugs have been approved by the FDA for marketing
to the public and makes recommendations on modifications to prescribing
protocol, warnings, and continuation of marketing.
Challenge
Accutane® (brand-name for the drug isotretinoin)
is designed to treat patients who have recalcitrant, nodular acne.
We have received beginning in 1997, and continue to receive, a
multitude of informal adverse reaction reports from health care
providers and patients incriminating isotretinoin as a possible
trigger of inflammatory bowel disease (IBD). IBD comprises two
distinct diseases—Crohn's disease and ulcerative colitis.
These are incurable diseases that generally require lifelong medication,
often multiple surgeries, and occasionally removal of colon and/or
intestine. A related drug, Tegison® (etretinate), is prescribed
for mature adults who suffer from psoriasis. The reports we have
studied have also implicated etretinate in the onset of IBD.
Approach
We assisted patients and health care providers
in reporting these adverse events to the pharmaceutical manufacturer
and to the FDA. We reviewed a collection of reports through 1995
from the FDA's MedWatch Program. We collaborated with various IBD
researchers in an intensive study of the medical literature and
interviews of medical authorities and health care providers. We
published a piece in the American Journal of Gastroenterology [Prokop.
Isotretinoin: Possible Component Cause of Inflammatory Bowel Disease.
1999;94(9):2568] and prompted another case study [Reniers and Howard.
Isotretinoin-Induced Inflammatory Bowel Disease in an Adolescent.
2001; 35:1214.]. We were were invited to give a talk on a nationally
syndicated radio show (Tom Martino's The Troubleshooter. 7/2001)
and to give a presentation at a 2002 medical and legal scientific
symposium (Extant Medical and Legal Consulting, 3/2002, Birmingham,
Alabama).
Solution
The FDA's CDER (Center for Drug Evaluation and
Research) reviewed our report and all of the ensuing expert attention.
As a result, CDER modified its WARNING on Accutane to call special
attention to its possible gastrointestinal (GI) effects and to
the fact that these effects might not disappear once Accutane treatment
is ceased. In addition CDER mandated distribution of enhanced WARNINGS
and required their acknowledgement by signatures of all patients
for whom Accutane is prescribed. It also added a "Drug Information" section
on its Web site to call special attention to widespread evidence
of unanticipated side effects of this and other drugs.
"Your
... thorough, meticulous and effective efforts
in the areas of
labeling, assembing data,
prompting studies
of risk factors
for IBD, and communication of risks to clinicians
and consumers are deserving of the highest praise and gratitude."
PJ Seligman, MD, MPH
Director
of Pharmacoepidemiology & Statistical Science
Center for Drug
Evaluation & Research, FDA
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