Friday, February 10, 2006
iPledge . . . not to have sex (or, if I do, to use 2 forms of birth control)
This article in yesterday's NYT describes the measures required of women who wish to take Accutane, a powerful anti-acne medication. The medication can cause severe birth defects, so the FDA and the drug's manufacturers have agreed on mandatory prescribing rules. To have their prescriptions filled, women must either (a) promise--in writing--not to have sex with a man (or men), or (b) use two forms of contraception, one of which must be deemed "highly effective," such as Depo-Provera injections. They must also document this on a website, iPledge. Others who are prescribed the drug but who cannot become pregnant (including men) are also required to register.
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5 comments:
First, without this pledge I wonder if women who do not have sex with men could have gotten the script (with the present rules in place that is). Second, it has always been a mystery to me how they could check up on whther a woman was using two forms of birth control (if she were sexually active). Third, I have heard tell that this script is overprescribed. It works for what it says it will work for, disfiguring cystic acne (which is very painful) but it is not indicated for the occasional breakout.
My understanding is that *everybody* who wants the drug (including men, women who have had hysterectomies, and presumably lesbians as well) has to sign up before they can get it. The question about enforcement is an interesting one, and it brings to the surface the real reason for the rule, which is (naturally) to protect the drug company from liability from bad birth outcomes. ("We told her not to do that, and she lied. . .") Your last question, re whether it's overprescribed, I don't know the anaswer to.
I am a 35 year old woman who has been diagnosed with Pyoderma Fascile - a severe form of nodular acne that can spread very quickly and leave terrible scarring if not treated quickly. I am outraged, to find that the medicine I need I cannot get because the FDA does not trust that I (a woman) am not responsible enough to make sure I use birth control while on Accutane. The other day at the dr office, I sat and watched a 17 yr old boy (who I know will not think twice about having sex with his girlfriend) get a prescription for Accutane that "HE" can start that day. I on the other hand even with a "negative" pregnancy test was told I have to wait "another" 30 days(for a second negative pregnancy test) before I can get my prescription for Accutane. What will my face look like in 30 days? I understand trying to keep babies from being born with severe deformities but this program is all wrong. The women,like myself, who would even abstain from sex while taking such a strong drug are being punished and forced to suffer permanent emotional and physical damage. Does anybody know how to get this program changed - help me if you can.
Write to the FDA. I am considering doing that myself, as the execution of this program has serious flaws.
www.accutanelog.blogspot.com
My name is Janice Still and i would like to show you my personal experience with Depo-Provera.
I am 24 years old. I have been on Depo for 9 years and did not realize that the symptoms I experienced might be related to the shot. I am now facing thousands of dollars in dental work due to bone density loss, and will probably end up with osteoporosis. I am getting off Depo and will never touch it again!
I have experienced some of these side effects-
Low libido, joint pain, bone density loss, dental problems, headaches, fatigue, out of control eating, gained 40 lbs., depression
I hope this information will be useful to others,
Janice Still
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