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Inflammatory Bowel Disease and Isotretinoin:
Litigation Concerns
author:
Noah Scheinfeld, M.D., J.D.
Deciding whether or not to alert patients to any potential
treatment warnings before performing a procedure or
prescribing a medication is not always a cut-and-dried
issue. As a guideline, I figure that if a side effect
has a 1 in 100 chance of happening, I think it is worth
mentioning to a patient.Using this communication guideline,
I warn all patients for whom I prescribe intralesional
kenalog (ILK) 3 mg/cc for inflamed acne cysts that they
may experience atrophy, but that if they do, it is usually
temporary. Specifically, I explain that a divet can
result from both ILK or resolved inflammatory acne papules,
pustules or cysts.However, on the other hand, I do not
routinely note that azithromycin has been correlated
with development of transient, and even permanent, deafness
(six cases reports) because this side effect is so rare
when you take into consideration the millions of prescriptions
written for this drug.What We Need to Know Regarding
Isotretinoin and Inflammatory Bowel DiseaseThat brings
us to isotretinoin, a medication that in recent years
seems to have engendered more discussion and controversy
than the disease that it treats. Since its approval
in 1992, up until 2000, 20 million prescriptions for
isotretinoin were written. The Accutane patent expired
on Feb. 7, 2002, but with the risk management program
iPLEDGE, the isotretinoin molecule has not left the
news. Because of all of this attention, it is probably
worth mentioning to patients all of the potential side
effects to make them fully aware. Rare Side Effect Worth
Mentioning A rather obscure side effect of isotretinoin
is the induction of inflammatory bowel disease. Lawsuits
have been filed regarding this side effect in several
states including Nebraska and Illinois. The first such
trial ended last month when a jury ordered Hoffmann-La
Roche to pay $2.6 million in damages. The corporation
is appealing. A lawsuit was reported in February of
2007 in Godfrey, Madison County, Illinois, involving
23-year-old Jason Christopher Peipert who sued both
Roche Laboratories and his physician Daniel Goran, M.D.,
on Dec. 16, 2003. The claim was that Accutane caused
him to sustain severe and permanent injuries. The Madison
County trial, which is set for October, will likely
be watched around the country and could serve as a bellwether
for hundreds of other lawsuits. This section is based
on a report in the Madison Record.1 Mr. Peipert claimed
that Dr. Goran prescribed Accutane to him in 1999 for
general care and treatment of acne. He claimed that
Dr. Goran was negligent because he failed to recognize
that Accutane is a difficult drug to manage in patients
and failed to run diagnostic tests to ascertain whether
he was developing the severe side effects of Accutane.
Mr. Peipert also claimed that Dr. Goran prescribed Accutane
to him more frequently and for periods longer than has
been approved by the FDA and failed to advise him of
the risks and side effects associated with Accutane.
According to court records, Mr. Peipert claimed that
Accutane caused him to develop Crohn’s disease,
the ulcerative and inflammatory disease of the bowel.
He also claimed that once he began to experience certain
side effects, Dr. Goran continued to prescribe the medication
after failing to recognize that Accutane was causing
the problems. Mr. Peipert also cited the company, claiming
that Roche either knew or should have known that Accutane
was causally related to and associated with severe and
life-threatening complications and side effects. He
alleged that the medication was defective and contained
unreasonably dangerous design defects and was not reasonably
safe, therefore subjecting users to risks that outweighed
the benefits of the drug. Mr. Peipert also claimed that
Accutane was insufficiently tested and that it caused
harmful side effects that outweighed any potential utility.
He further claimed that Roche failed to adequately instruct
on the length of time an individual should be allowed
to continue using Accutane. On Feb. 20, 2007, Dr. Goran
filed a motion for summary judgment claiming that none
of Mr. Peipert’s witnesses disclosed opinions
critical of his standard of care. Judge Hylla had not
yet ruled on the motion. Dr. Goran, represented by Jeffrey
Reel of Belleville, also claimed that Mr. Peipert did
not develop symptoms associated with Crohn’s until
2 years after he stopped taking Accutane. Mr. Reel argued
that there was no evidentiary basis from which the jury
could conclude that he failed to properly advise Mr.
Peipert of the risks and side effects of Accutane.It
should be noted that not all of these cases go forward.
The family of a boy who killed himself by slamming a
stolen single-engine plane into a skyscraper in Florida
4 months after the 9/11 attacks has dropped its $70
million lawsuit against the manufacturer of isotretinoin.Other
Evidence of a Potential LinkWhile all dermatologists
are aware of the healing effects of isotretinoin, some
data exist that link it to inflammatory bowel disease.
In an article in the American Journal of Gastroenterology,
Reddy et al examined all of the adverse reports filed
with the FDA between 1997 and 2002 regarding isotretinoin
to see if ulcerative colitis and Crohn’s diseases
were linked to the use of isotretinoin.2 Specifically,
Reddy was part of a group of investigators that queried
the FDA for MedWatch reports containing the keywords
isotretinoin, Accutane, colitis and IBD. In an article
in Dermatology Times, Corey A. Siegel, one of the study’s
authors, stated that “while the Physician’s
Desk Reference lists IBD as a possible adverse event
associated with use of isotretinoin, our goal was primarily
to determine if this association was legitimate, and
if so, what it means to physicians and patients.”3The
Results Of This ReviewReddy et al found 85 cases of
ulcerative colitis and Crohn’s diseases associated
with isotretinoin use. According to the Naranjo ADR
probability scale, which evaluates the likelihood of
a drug-related side effect:• four cases (5%) scored
“highly probable” for isotretinoin as the
cause of ulcerative colitis and Crohn’s diseases
• 58 cases (68%) were “probable” •
23 cases (27%) were “possible” • no
cases were “doubtful”. Reddy et al concluded
that in a subgroup of patients, isotretinoin might serve
as a trigger for ulcerative colitis and Crohn’s
diseases. Other reports from Europe have similarly noted
that ulcerative colitis and Crohn’s diseases occur
rarely following use of isotretinoin.4-7I do not want
to comment on the pending lawsuits — besides,
the facts of every case are particular to that case.
It would seem to me that ulcerative colitis and Crohn’s
disease are only rarely linked to the use of isotretinoin;
and in fact, the pyoderma faciale related to ulcerative
colitis and Crohn’s disease is well treated with
isotretinoin.8,9 On the other hand, the link of ulcerative
colitis and Crohn’s disease to the use of isotretinoin
was noted, however rare, in the 1980s and 1990s.10-12What
Should We Tell Our Patients?It might seem prudent in
the current litigation environment to query potential
isotretinoin patients about depression, ulcerative colitis,
Crohn’s disease, and other very rare side effects
and warn them of the supposed association — however
far-fetched — between acne and depression (which
seems to have been disproved in a major study), ulcerative
colitis and Crohn’s disease with isotretinoin
use. Perhaps iPLEDGE can be used as a platform to provide
patients with data about obscure side effects of isotretinoin
and require patients and doctors to document that isotretinoin
might have rare side effects and that doctor and patient
have considered these and decided that the benefits
outweigh the risks of isotretinoin and that the patient
has accepted the implications of risk.It is widely accepted
that malpractice cases and litigation flow from bad
feelings that patients experience in regard to a doctor/patient
interaction, even more so than bad outcomes. Educating
patients and keeping lines of communication open are
the first steps to avoiding litigation.
References:
References 1. Steve Gonzalez. First ever Accutane trial
set in Madison County. February 22, 2007. http://www.madisonrecord.com/news/190897-first-ever-accutane-trial-set-i...
2. Reddy D, Siegel CA, Sands BE, Kane S. Possible association
between isotretinoin and inflammatory bowel disease.
Am J Gastroenterol. 2006 Jul;101(7):1569-73. 3. John
Jesitus Isotretinoin possibly linked to IBD. Dermatology
Times. Oct. 1, 2006. http://www.dermatologytimes.com/dermatologytimes/article/articleDetail.j....
4. Pettersson U, Mjorndal T. Roaccutane and inflammatory
bowel disease. Lakartidningen. 2006 Dec 13;103(50-52):4047.
5. Passier JL, Srivastava N, van Puijenbroek EP. Isotretinoin-induced
inflammatory bowel disease. Neth J Med. 2006 Feb;64(2):52-4.
6: Duong M, Dinoulos JG, Gupta A, et al. Index of suspicion.
Pediatr Rev. 2005 Jan;26(1):23-33. 7. Borobio E, Arin
A, Valcayo A, Inarrairaegui M, Nantes O, Prieto C. Isotretinoin
and ulcerous colitis. An Sist Sanit Navar. 2004 May-Aug;27(2):241-3.
8. Rosen T, Unkefer RP. Treatment of pyoderma faciale
with isotretinoin in a patient with ulcerative colitis.
Cutis. 1999 Aug;64(2):107-9. 9. Godfrey KM, James MP.
Treatment of severe acne with isotretinoin in patients
with inflammatory bowel disease. Br J Dermatol. 1990
Nov;123(5):653-5. 10. Prokop LD. Isotretinoin: possible
component cause of inflammatory bowel disease. Am J
Gastroenterol. 1999 Sep;94(9):2568. 11. Martin P, Manley
PN, Depew WT, Blakeman JM. Isotretinoin-associated proctosigmoiditis.
Gastroenterology. 1987 Sep;93(3):606-9. 12. Brodin MB.
Inflammatory bowel disease and isotretinoin. J Am Acad
Dermatol. 1986 May;14(5 Pt 1):843.
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