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Accutane
Continues to Pose Serious Risks
In 1988, a Roche sponsored program called the
pregnancy prevention program (PPP) was put in place to
prevent birth defects from the use of Accutane. The
program provided educational materials for physicians
and patients and also facilitated contraceptive use for
women on Accutane by reimbursing for the
contraceptive counseling. Also as part of the PPP,
women who were taking isotretinoin were asked to
enroll in the Boston University Accutane Study (BUAS).
Enrollment was voluntary and the BUAS estimated that
about 40% of women taking isotretinoin enrolled. Over
the course of the study period, 1989 to October 1999,
approximately 500,000 women enrolled. Among that
group there were 958 pregnancies. A large proportion of
the pregnancies, 834, ended in termination (either
elective, spontaneous, or due to ectopic pregnancies),
110 resulted in live births, and 14 had unknown
outcomes. Of the 60 infants with available medical
records, 8 had congenital abnormalities.
Concerns about exposure to isotretinoin during
pregnancy continued through the late 1990s and into
2000. Roche began a second program called SMART
(The System to Manage Accutane Related
Teratogenicity) in 2002. SMART includes patient
information and labeling materials (booklets, video, and
medication guide), consent forms, and yellow
qualification stickers that providers need to
affix to prescriptions indicating that patients have met
all criteria for receiving Accutane prescriptions.
Calls for Closer Monitoring Being Made
The SMART Program continues to be voluntary and,
unfortunately, pregnancies continue to be exposed to
and affected by isotretinoin, an entirely preventable
cause of birth defects. The March of Dimes has called
for tighter controls on the use of Accutane and other
recently available generic forms of isotretinoin. Early in
2004, March of Dimes urged the FDA to mandate a
single, stringently monitored and restricted program for
isotretinoin, such as the highly effective system created
for thalidomide when it was licensed in 1998. Such a
system would require provider registration and
monitoring of prescriptions. Rather than simply being
voluntary recommendations, many of the same
safeguards around pregnancy testing and contraceptive
use would be mandatory.
Recognizing Fetal Isotretinoin Syndrome
Smith's Recognizable Patterns of Human Malformation
reports that retinoic acid embryopathy, also known as
Accutane embryopathy or fetal isotretinoin syndrome,
consists of a set of malformations involving the central
nervous system, head and face, and heart. Isotretinoin
(13-cis-retinoic acid) is a synthetic retinoid or vitamin A
derivative. The retinoids are involved in the HOX
signaling pathways that are used to pattern the
branchial arches (pharyngeal arches) during the fourth
week of embryonic development. It is not surprising,
therefore, that the derivatives of the pharyngeal arches
are affected by isotretinoin exposure during pregnancy,
namely the central nervous system (CNS), craniofacial
features, and cardiac structures.
Children with the isotretinoin syndrome often
demonstrate facial asymmetry; serious external ear
abnormalities, including microtia (small ear), anotia (no
ear), or stenosis of the external ear canal; micrognathia
(small jaw); flat depressed nasal bridge; and ocular
hypertelorism (widely spaced eyes). The cardiovascular
abnormalities commonly seen include conotruncal
malformations, such as transposition of the great
vessels and tetralogy of Fallot. Effects on the CNS can
lead to hydrocephalus and microcephaly as well as to an
IQ in the subnormal range and learning disabilities.
Thymic aplasia and parathyroid abnormalities can also
be part of this syndrome.
Congressman Stupak's Index of Accutane Information Including FDA
Letters, Manufacturer Guidelines, etc. (Very Good)...
http://www.house.gov/stupak/accutane.htm
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Accutane
Continues to Pose Serious Risks |
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