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Accutane refers to the
commercial brand name for Isotretinoin, which is used for treating
acne and is known as a Vitamin A derivative. In the succeeding months
after its initial release in 1982, there were substantial findings
made, which revealed that there were some harmful or negative effects
with the use of the drug on pregnant and lactating women. In 1983,
some consumer welfare organizations wrote a petition, which asked the
US Food & drug Administration (FDA) to conduct a probe on its
manufacturer, La Roche, and to force them to post warning labels on
the drug and inform consumers of its adverse effects especially on
pregnant women.
Accutane and Pregnancy
While the primary indications for Accutane are for treating acne, it
has been noted to cause severe birth defects when used by pregnant
women. Health experts and consumer groups say that contraception
should be purely mandatory for women who are using this medication. In
the early months after the drug’s commercial release, rising concerns
among consumer groups led to the crafting of a petition which called
for the ban on the release of this product in 1988.
Available figures reveal that around 25 percent of pregnant women
using Accutane had experienced serious birth defects on their
offspring, while around 50 percent of the pregnancies on women using
Accutane resulted in some form of mental disability on their babies.
The rising concerns on Accutane and pregnancy revolve around fears
that the drug induces defects which involve the central nervous
system, heart and blood vessels, liver, as well as in creating
deformities on the skull and face of infants.
Advice for Women Using Accutane
With increasing fears revolving around Accutane and pregnancy, health
experts are advising women to follow strict guidelines, which are
essential in protecting their offspring especially if they are
lactating or pregnant. Women are strongly cautioned not to take
Accutane if they are pregnant, or if they think they could become
pregnant during the treatment stages. The US Food and Drug
Administration (FDA) warn that Accutane is known to cause severe birth
defects on unborn babies, and could also lead to premature birth,
miscarriage or the resulting death of the baby.
Women who are using Accutane are strongly advised to use contraception
during this stage to prevent unwanted or untimely pregnancies. Doctors
also stress that undertaking a Level Three ultrasound would also help
in finding out whether structural defects are present on pregnant
women. While this type of ultrasound may not fully indicate whether
there are birth defects seen on the baby, it’s also best that
lactating women seek advice from their obstetrician. He who would then
refer them to a Maternal or Fetal Medicine specialist in order to
better assess their risk factors and review the best possible course
of treatment for them.
The FDA’s current guidelines clearly stress that women who use
Accutane and become pregnant face a much higher risk of placing their
unborn children in a dangerous situation, as the levels of birth
defects have been noted to be much higher in women who use these types
of medications.
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