Category X: Pregnancy Danger
- Sierra Gillespie
- Oct 14, 2015
- 4 min read
There are many side effects to the intense drug Accutane, look here if you’re interested, but likely the most severe side effect of all is birth defects.
Classified as Category X by the FDA, pregnancy while on Isotretinoin, commonly referred to as Accutane, is the worst of the worst. When explaining to me the side effects of pregnancy on Isotretinoin, Dr. Rebecca Pedretti noted that if I did become pregnant while on the drug, I would be strongly urged to have an abortion.
Usually for babies born with the influence of Isotretinoin, the effects range from mild to severe. Most commonly, babies are born with cleft palates, though some have been documented as born with cone-shaped heads, central nervous system malformations, missing ears and facial deformities. According to drugwatch.com, 42 percent of children born to current Accutane patients are affected with these issues.
In attempt to curb these Isotretinoin-based pregnancies, the FDA created several programs for Isotretinoin patients. The first, SMART, which stood for System to Manage Accutane Related Teratogenicity, was implemented in 2002, but was short-lived. The current program, iPledge, was implemented in 2006 and continues today.
iPledge is a strict, Internet-based system used for female Isotretinoin patients in attempt to warn them of pregnancy while on the drug. As it was implemented by the FDA, pharmacists are unable to issue Isotretinoin prescriptions without the completion of monthly iPledge quizzes about safe sex.
In order for females to be permitted to use the “Accutane” drug, they are required to have a monthly lab-visit, testing their blood levels and urine for pregnancy. In addition, patients are to have a consultation with their dermatologist, during which they are to decide which two methods of birth control they are to use.
With iPledge, two forms of birth control are required as opposed to just one. Dermatologists and patients alike must enter each birth control method in the exact same order, otherwise iPledge cancels the Isotretinoin order and patients are unable to receive their prescription.
After entering their two forms of birth control, patients must complete an iPledge quiz after their pregnancy test comes back negative.
For most people, iPledge safe sex quizzes are very simple. For example, one question asked the following:
My partner only has one condom with him. We would:
A. Have sex more than once and reuse the condom.
B. Have sex once and wait until he can buy more condoms.
C. Have sex but use withdrawal.
Still, the severity of pregnancy while on Isotretinoin is not resonating with patients. According to a study completed by the University of Pittsburgh School of Medicine, 150 women on Accutane become pregnant annually. This figure portrays women who get pregnant despite all the iPledge implemented hurdles and warnings.
Unfortunately, iPledge has not done the job the FDA intended for it. Since its debut in 2006, iPledge has reduced Isotretinoin based pregnancies by less than one percent, as published by the Journal of the American Academy of Dermatology.
Evidently, women are not taking the warnings iPledge screams as serious warnings. In the same study conducted by the University of Pittsburg School of Medicine, of the 150 women who were surveyed, 75 women cited abstinence as their primary form of birth control, though 19 percent of participants were sexually active regardless.
Of the 150 women surveyed, 12 women admitted to having intercourse with one or fewer forms of birth control, 10 did not use condoms, and one patient had unprotected intercourse. For those who used the birth control pill as their primary form of birth control, 39 percent stated they missed one or more pills during the previous month of their prescription.
Since its debut in 1982 by the Swiss based company Hoffmann-La Roche, Accutane has caused numerous deformations in infants. Namely because of this side effect, though unfortunately not limited to just pregnancy based deformities—many Accutane patients claim to suffer Inflammatory Bowel Disease or Crohn’s Diease because of the prescription—Hoffman-La Roche removed Accutane from the market in 2009.
Currently, Isotretinoin is mainly marketed as Amnesteem, the first generic version of Accutane that debuted in 2002. iPledge still resides over all Amnesteem patients, in hopes of limiting pregnancy while on the drug.
The rating of a Category X by the FDA should inspire careful consideration in females while on Isotretinoin, and the next 30 days after their final pill. The severity of the deformed pregnancies, among other side effects of Isotretinoin, are not meant to scare patients, but to inform them, and make sure they change their day-to-day actions in order to complete their course of prescription safely.
Unfortunately, many patients disregard warnings, and proceed with their lives without taking necessary measures. Even for those who do take caution, six+ months of their lives are focused on a regulated form of sexual intercourse, possibly putting a damper on their relationships, lifestyle choices or even their overall mood.
Women across the world face half of a year regulating themselves, in the hopes that their acne subsides, regardless of possible side effects ranging from suicidal based depression to cone-head shaped babies.
So, my question about the social stigma of acne continues: why is this still a stigma?
Look to the courage of women across the world facing a future of deformity and illness. Their lives with acne are truly so subpar that they do not regard the possible side effects of Isotretinoin.
While many patients should be more careful about forms of birth control regarding intercourse, many Isotretinoin users are careful, yet still subject themselves to a significant portion of time living their life on standby.
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