Interesting practical experiment...

iVillage Member
Registered: 06-03-2007
Interesting practical experiment...
2
Mon, 08-06-2007 - 11:59am

Things that make you go, "hmmmmm..."

One of many drugs that is profoundly damaging to a fetus is the acne drug Accutane. In an effort to curb exposure in utero, the FDA recently started this interesting program that physicians, pharmacists and all patients who want to use the drug have to comply with to get it. It's called iPledge. All patients have to register, even though it's aimed at women of childbearing age. They have to agree to be on birth control, and here's the kicker - provide a negative pregnancy test every single month when they want their refill on the Accutane.

Monday, the results from the first year of the program cam in. Over 300k patients signed up to get the drug, including 137,415 women of childbearing age. The registry allowed 91,894 of them to receive at least one prescription. 122 pregnancies were reported! 78 were taking the drug when they became pregnant. Another 10 were already pregnant when they started isotretinoin, including two who had a prescriber falsify pregnancy test results!! The report didn't give a reason. Another eight became pregnant in the month after stopping the drug (still at severe risk for embryonic damage). The program couldn't provide details on the remaining pregnancies.

I just found this very interesting. It's invasive as heck, but they managed to get their preg rate down below 0.1%, consistant with very high quality use of birth control! Does this have to do with the huge amount of oversight with birth control activity? I mean, with that much programming, these women must have had tons of chances to discuss birth control and how it works with their providers.

I guess that with a hugely motivated population that has already had all the noncompliant patients cut out it's hardly something we could scale up, nationwide. So there isn't much practical action to recommend from this (except to perhaps require registries like this for all teratogenic medications??) but I found it so interesting I had to post.

Here's a news article about it:

http://www.usatoday.com/news/health/2007-07-30-accutane-pregnancy_N.htm

iVillage Member
Registered: 07-29-2004
Mon, 08-06-2007 - 4:04pm

According to two of my friends that were on it, they had to use 2 forms of BC and celibacy couldn't be one of them, although both of my friends were both celibate at the time (one by choice, the other by chance). Which brings up interseting arguments, did they take men and women who were unable to conceive out of the study numbers, and did they take those women who were not sexually active out of the study numbers. These could have HUGE impacts on the numbers.

But, I would think that increased oversight on birth control activities (both my friends had to obtain BCP prescriptions and show proof of filling them regularly) would seriously decrease incidents of failure.

iVillage Member
Registered: 06-03-2007
Mon, 08-06-2007 - 5:06pm

From my understanding (not reading the study publication, but the news article, which I know is lame) they only counted supposedly fertile women in the ~134k, but did include those who were celibate along with those that were sexually active.

What really skews the numbers is the ~~40k women who seem to have been prevented from getting Accutane because they wouldn't agree to use two forms of BC and provide the preg tests. Without noncompliant patients, medical interventions work a lot better.