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 “When I first prescribed the drug in the 1980s we were quite afraid
of the drug and very cautious,” Dr. David Henry from the Institute
for Clinical Evaluative Sciences in Toronto told Reuters Health. “I
fear some of that has been lost through familiarity.”
Numerous studies from several countries have shown that women taking
isotretinoin aren’t aware of - or simply ignore - the pregnancy
prevention guidelines.
Henry and colleagues used prescription records from 1996 to 2011 to
estimate how often pregnancy occurred during and after treatment
with isotretinoin. They also looked at how many women taking
isotretinoin also had prescriptions for oral contraceptives before
and while using isotretinoin.
Of the nearly 60,000 women who received isotretinoin, as many as 55
percent had not tried other, less dangerous acne drugs first (a
clear violation of prescribing guidelines).
In the year before their isotretinoin treatment, 28 to 36 percent of
women (depending on where they lived) used oral contraceptives - and
the percentage did not go up during isotretinoin treatment.
As reported in CMAJ, about four to six of every thousand women using
the medication got pregnant. And four times that many got pregnant
within 42 weeks of taking it.
Of the 1473 pregnancies recorded during this study period, 118 (8
percent) resulted in live births, 290 (20 percent) resulted in
miscarriages, and 1041 (71 percent) were ended by abortions.
Eleven (9 percent) of the live babies had birth defects.
“Medical practitioners and patients must be constantly reminded of
the risks of isotretinoin to the fetus and must adhere to the policy
that mandates effective contraceptive measures,” the researchers
say.
“There is persistent incomplete adherence to very clear requirements
for prescribing and dispensing the drug to young females,” Henry
said. “And this will be an underestimate as it is based only on
publicly funded insurance programs and does not include privately
purchased drug and online supplies (which are cheap).”
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Henry emphasized that women and their doctors need to “undertake the
necessary steps to exclude pregnancy before commencement, to
minimize risk during pregnancy, and to monitor for pregnancy during
and after treatment. It’s quite an intensive process when done
properly.”
Dr. Bruno Stricker from Erasmus University Medical Center,
Rotterdam, The Netherlands found similar risky behavior during
isotretinoin use there. He told Reuters Health, “Basically, there
are three options, i.e., not being pregnant, not prescribing
isotretinoin, or prescribing isotretinoin only after strict written
informed consent and a pregnancy test. Of course, even then things
may go wrong, unfortunately, but the risk for that will be
smallest.”
In the U.S., the Food and Drug Administration requires women to
register at iPLEDGE (http://bit.ly/1Vy6Awi), complete an informed
consent form and receive counseling about the risks associated with
the drug, and it requires women of childbearing age to comply with
pregnancy testing. Only registered prescribers and pharmacists are
permitted to prescribe and dispense isotretinoin.
Despite this requirement, studies in the U.S. have documented
similarly low use of effective contraception, low compliance with
pregnancy prevention programs, and high rates of birth defects and
abortion after maternal isotretinoin use.
SOURCE: http://bit.ly/1TtgonL CMAJ, online April 25, 2016.
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