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Women taking Accutane still getting pregnant despite iPledge
Filed under: Your Pregnancy, Health & Safety: Babies
Accutane is a powerful prescription medication used to treat severe acne. Besides clearing your skin, it can also cause profound birth defects when taken by pregnant women. Even small doses taken for short periods can result in damage to an unborn child, including severe brain damage, heart defects and mental retardation. Even after stopping the drug, the risk remains for thirty days.
In an effort to prevent women from becoming pregnant while taking Accutane, a program called iPledge was created. It was intended to eliminate the risk through mandatory education, counseling and most importantly, by requiring female patients to commit to using two forms of contraception and to submit to monthly pregnancy tests. In theory, prescriptions will not be filled without proof of a negative result on the pregnancy test.
New figures released from the iPledge registry reveal that despite these precautions, women continue to get pregnant while taking the drug. The numbers show that there were 122 pregnancies during the first year of the program. Of those pregnancies, 78 were actually taking the drug at the time they became pregnant. Another 10 were already pregnant when they first began taking the drug - including two who deliberately had their pregnancy tests falsified. Eight more women became pregnant within a month after stopping the drug.
Most of pregnancies are blamed on the old standby - forgetting to take birth control, although 18% had been relying on abstinence. I don't get that. I thought it was impossible to get pregnant if you didn't have sex?
Even with the obvious failure of the iPledge program, manufacturers of the drug are pushing the FDA to make it easier to get a prescription for those who aren't at risk of becoming pregnant. Until they resolve these issues, I don't think making this drug easier to obtain is a good idea.
In an effort to prevent women from becoming pregnant while taking Accutane, a program called iPledge was created. It was intended to eliminate the risk through mandatory education, counseling and most importantly, by requiring female patients to commit to using two forms of contraception and to submit to monthly pregnancy tests. In theory, prescriptions will not be filled without proof of a negative result on the pregnancy test.
New figures released from the iPledge registry reveal that despite these precautions, women continue to get pregnant while taking the drug. The numbers show that there were 122 pregnancies during the first year of the program. Of those pregnancies, 78 were actually taking the drug at the time they became pregnant. Another 10 were already pregnant when they first began taking the drug - including two who deliberately had their pregnancy tests falsified. Eight more women became pregnant within a month after stopping the drug.
Most of pregnancies are blamed on the old standby - forgetting to take birth control, although 18% had been relying on abstinence. I don't get that. I thought it was impossible to get pregnant if you didn't have sex?
Even with the obvious failure of the iPledge program, manufacturers of the drug are pushing the FDA to make it easier to get a prescription for those who aren't at risk of becoming pregnant. Until they resolve these issues, I don't think making this drug easier to obtain is a good idea.
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ReaderComments (Page 1 of 1)
8-03-2007 @ 11:05AM
caitlin said..."although 18% had been relying on abstinence. I don't get that. I thought it was impossible to get pregnant if you didn't have sex?"
They probably had an abstinence based sex ed program like the one I had to go through in high school. "Sex" was defined as coitus. If you didn't do that, then technically it wasn't sex and you were abstaining. There was no mention of the slight risk of pregnancy other types of sexual play carry and you have to be careful of whose fluids end up where.
Reply
8-03-2007 @ 11:36AM
Pops said...Abstinence can fail just as (in fact, moreso) easily than other kinds of birth control.
Forgetting to take a birth control pill and then calling it a failure of the birth control is no different than "forgetting" to abstain.
Reply
8-03-2007 @ 12:01PM
Eva said...I took Accutane and it was very clear to me the risks involved if you got pregnant. These women have no excuse for not taking better care of themselves and their unborn children. It is their responsibility not to take this medicine if they can't refrain from pregnancy (not that hard to do, really).
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8-03-2007 @ 2:29PM
SKL said...My sister won't go on epilepsy drugs because of the potential harm to a potential unborn child. (She has never been pregnant, but plans to be someday.) Instead, she has made substantial lifestyle changes to manage her risk of seizures.
I find it surprising that people would risk severe birth defects just to get rid of acne.
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8-03-2007 @ 4:36PM
Ann Adams said...I shouldn't even be in this discussion but, hypothetically speaking, I can't imagine knowingly taking something that would cause birth defects.
But then I'm old enough to remember thalidomide.
I was going to make a flip comment about "abstinence" but several others beat me to it.
Reply
8-03-2007 @ 6:40PM
Marieke in Amsterdam said...Why don't they make these women have Medroxyprogesterone Injections? Then no one had to worry about getting pregnant for 12 weeks in a row. BTW, in Holland it's very hard to get an Accutane prescription being a woman in her fertile years.
Women tend to get a Diane 35 prescription, which is a birth control pill but working great against acne. Almost every health insurance covers birth control (with the notable exception of condoms).
And since under the Health Insurance Act all residents of the Netherlands are obliged to take out a health insurance (150-200 US $/month, no compulsary excess, almost everything covered), there's no reason not to use it.
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8-04-2007 @ 2:18AM
Gry said...I, too, was going to say something about abstaining, but it's just not worth it, heh!
But I totally agree with Marieke - why not give them the shot?
Reply
8-04-2007 @ 11:00AM
jf said...In reply to SKL:
I took Accutane when I was in late high school. Severe Acne is more than just a nuisance, it is a health issue. Most dermatologists only prescribe Accutane after other types of treatment have failed to work. Even as a high school student who was not (and had never been) sexually active, I understood the risks involved in taking the drug. I took birth control while ALSO abstaining from any sexual activity. These women are being irresponsible, but many women do take Accutane responsibly as a way to treat severe acne.
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