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Accutane Registry to Begin Next Week

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February 22, 2006

Accutane Registry to Begin Next Week

By THE ASSOCIATED PRESS

Filed at 10:46 a.m. ET

WASHINGTON (AP) -- Dermatologists are renewing their concerns that efforts to prevent pregnant women from using a drug that can cause birth defects may also keep the drug from patients who need it for severe acne.

The iPledge program to register women of childbearing age who use the drug Accutane and its generic versions -- requiring them to have pregnancy tests before getting a prescription -- is scheduled to take effect March 1.

The American Academy of Dermatology had urged the Food and Drug Administration to postpone the start of iPledge, but said Tuesday the FDA had advised it that the program will begin as planned.

The FDA had delayed implementation from last November to March 1, but did not immediately confirm the decision not to postpone it further.

The program focuses on the drug isotretinoin, best known as Accutane but also sold generically as Amnesteem, Claravis and Sotret.

AAD President Dr. Clay J. Cockerell said in a statement he was disappointed in the decision not to delay iPledge, adding that ''it is now the duty of the FDA to guarantee that the flaws, inconsistencies and confusion'' in the program are resolved.

Dr. Diane M. Thiboutot of the Penn State University College of Medicine in Hershey, Pa., said attempts to use the system have shown it to be complex and that it may prevent patients from getting medicine for forms of acne that can cause severe scarring.

The system requires patients, physicians and pharmacies to register via computer and the patients must fill their prescription within a seven-day window. However, she said, some didn't get passwords in time, resulting in their being prevented from getting the drug for 23 days. She said other problems also occurred.

This is the only drug that can prevent severe scarring and ''we're really concerned that this system may mark the beginning of an inability of patients who need the medication to get medication,'' Thiboutot said.

If a pregnant woman uses the drug, or if a woman becomes pregnant within a month of taking it, her baby runs a significant risk of brain and heart defects, as well as mental retardation.

While the manufacturers of the four drugs have operated similar but smaller registry programs, FDA estimates that 100 to 140 pregnancies a year still occur in the United States in women on the drug. About 100,000 Americans are prescribed the drug monthly.

Since Accutane sales began in 1982, the FDA has received reports of more than 2,000 pregnancies among users. Most ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.

Under iPledge, women of childbearing age must undergo two tests to ensure they're not pregnant before the initial prescription, and monthly pregnancy testing before each refill. Home pregnancy tests won't do. The doctor must enter the pregnancy test results into the iPledge system, and the woman must buy her pills within seven days.

These women also must agree to use two forms of birth control while using the drug, and must self-register on iPledge -- in addition to the doctor's initial registration -- to report that they're doing so.

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On the Net:

FDA isotretinoin information: http://www.fda.gov/cder/drug/infopage/accutane/

Copyright 2006 The Associated Press Home Privacy Policy Search Corrections XML Help Contact Us Work for Us Site Map Back to Top

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i just started taking Acctuane last week and i needed a pregnancy test before they could give me it. its really no big deal, not like it takes a long time or anything...my derm did it right in her office.

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It is sort of a pain though. To have to register and answers questions every month. My derm doesn't do pregnancy tests in her office, so I have to go to another place have them done and then have the lab work sent back.

No, it is not a huge deal, but it still is a little bit of a pain.

I also know there are going to be all kinds of problems since the program is new. There will be many kinks that will have to be worked out and I fear there are going to be delays or hassles when trying to pick up my prescriptions.

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it makes no sense why men like myself need to register for this program. Absolutely unnecessary and pointless since the whole point is to prevent pregnancy.

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oh for crying out loud. If you are not an idiot, you will know you;re not supposed to get pregnant, and if u have a drop of responsibility, YOU WON'T get pregnant!

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it makes no sense why men like myself need to register for this program. Absolutely unnecessary and pointless since the whole point is to prevent pregnancy.

Unfortunately many of the exposed pregnancies happen when men who get the medication through proper channels give it to women who don't want to go through the hassle. However i fail to see how registering men (or anybody really) will prevent an exposed pregnancy.

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Unfortunately many of the exposed pregnancies happen when men who get the medication through proper channels give it to women who don't want to go through the hassle

what percentage of users is this? .001%? Ive never even heard of such a thing. Anyway the registry doesnt change anything in terms of this and provides no more protection. Just a hassle.

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I don't know the percentage, sorry. As far as i know, the data is unpublished, but my derm said it was a major problem.

But you are right that the registry is just more hassle, really for both men and women.

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I don't think this program really tells me anything I don't already know. If the derm is doing there job they are going to make sure you know all the side effects and dangers of this drug.

I understand the two forms of birth control being madatory, but there are parts of the program that are a waste. The binder they gave me is useless. I went through sighed and intialed all the places I needed to.

I am a respoinsible person and I don't need the goverment holding my hand through all of this.

I have gone 24 years with out getting pregnant and I will be able to go another 6 months.

Mr.life- I am pretty jealous that you don't have to go through this junk.

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I do feel for the 160 babies born who were exposed to accutane, but "100 000's of thousands of people are prescribed Accutane each month", that is alot of people. If you assume that it is only 100 000 per month, that is 1/ 28800000 babies per person perscribed. This isn't exactly an epidemic of deformed babies. I just feel all the time, money and hassle could easily go to another health condition that would save many more lives. Just my opinion.

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