Posted on 12/30/2005 11:49:51 PM PST by neverdem
ASSOCIATED PRESS
WASHINGTON -- A national registry on Friday began accepting names of Americans who take the anti-acne drug Accutane, part of a federal effort to limit use of the birth-defect-causing drug by pregnant women.
Doctors, wholesalers and pharmacies had until Friday to register with the computerized "iPledge" registry in order to continue prescribing or selling Accutane and any of the three generic versions of the drug, known as isotretinoin. Generic versions are sold as Amnesteem, Claravis or Sotret.
The Food and Drug Administration has tried for more than 20 years to limit the exposure of fetuses to the drug, prescribed to about 100,000 Americans a month. If a woman uses Accutane during pregnancy - or becomes pregnant within a month of taking the drug - her baby runs a significant risk of suffering brain and heart defects or mental retardation. Patients typically take the drug for five to six months.
Despite those previous efforts to control its use, anywhere from 100 to 140 pregnancies a year are still being reported in women on the drug, said Dr. Paul Seligman, director of the FDA office responsible for post-marketing drug surveillance.
The iPledge registry replaces and builds on previous programs, run individually by the four manufacturers.
"We hope it will be the program that ensures that we can get as close to the goal of the least pregnancy exposures as possible," Seligman said. The registry is similar to one used for thalidomide, which also causes birth defects.
All Accutane users must enroll by telephone at (866) 495-0654 or through the Internet at http://www.ipledgeprogram.com to receive the drug.
They also must sign a document informing them of the drug's risks, including the possibility that it contributes to depression or suicidal thoughts. The drug's labels have carried a similar warning since August.
Additionally, female patients of childbearing age must undergo two pregnancy tests before they can be prescribed the drug, along with a monthly follow-up test before each refill. They also must agree to use two different forms of birth control at the same time or not to have heterosexual intercourse for one month before starting isotretinoin, during treatment and for one month after treatment has ended, according to the FDA.
Pharmacists will have to check a computer database before filling a prescription to ensure patients are in compliance. All doctors and patients must be registered and activated in the iPledge system by March 1 to prescribe and take, respectively, the drug. Manufacturers are supposed to cut off pharmacies and wholesalers that violate the rules.
The manufacturer of Accutane, Roche Laboratories Inc., did not respond to e-mailed questions about the registry. Telephone messages seeking comment from its three generic competitors, Mylan Pharmaceuticals Inc., Barr Laboratories Inc. and Ranbaxy Laboratories Inc., were not immediately returned Friday.
An American Academy of Dermatology spokeswoman said the group never supported the registry concept for the drug.
"We don't believe isotretinoin is a medication that needs a registry. The academy has spent years educating its members about it," spokeswoman Jennifer Allyn said. "We felt that adding a registry for it would prevent people who really need this medication from getting it."
Isotretinoin is supposed to be prescribed only for the most severe acne, but is widely acknowledged to be prescribed for more minor cases.
Since Accutane sales began in 1982, the FDA has received reports of more than 2,000 pregnancies among users. The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.
On the Net:
iPledge: http://www.ipledgeprogram.com
FDA isotretinoin information: http://www.fda.gov/cder/drug/infopage/accutane/
Accutane-using women should be compelled to wear a scarlet "A" so that no one will have sex with them.
wow. hmmmm. Proactiv or Accutane? I think Proactiv. Worked for my kids.
I am going to jump right in here since I am sure that some well-meaning person is going to suggest that such a dangerous drug shouldn't even be on the market. (Obviously, that would *not* be a libertarian making that remark!) And what I have to say is that Accutane literally changed my life. I went through all of high school and college as a "pizza face," even though I saw a dermatologist, took scrupulous care of my skin, and took antibiotics for years at a time. Then I took Accutane, and in a few months, I had decent skin. It literally changed my life.
My dermatologist did sit me down and make VERY sure I understood the risks and that it was imperative I not get pregnant. My guess is that most dermatologists still do the same thing. I don't see how a registry is going to improve on that, unless they send a nanny to every registrant's home to follow them around 24/7.
I'll also stick with Proactive. (Worked for me, too!) :-)
Proactiv is great for most people. Accutane is meant for people who have a severe acne known as "severe recalcitrant nodular" variety.
I'll second that. Some types of acne just aren't caused by a benzoyl peroxide deficiency. My doc also took great care to explain the risks - not just to an unborn baby, but to me, too. It is a dangerous drug and not to be undertaken lightly. The registry website appears to underscore that fact.
Congrats on the help you found in Accutane. The class action law suit that follows will improve the lives of the litigation bar and remove another effective medication from the market.
Go get your hormones checked. A testosterone imbalance may cause acne. And it's more than testosterone. If one hormone is out of balance, it can throw the whole thing off. PCOS can cause acne in women.
Here's an example: If prolactin levels are high, one will make "milk". But if prolactin levels are normal, one may still make milk if testosterone is too low.
Whenever something goes wrong with your body, realize that it's probably a *symptom* not the problem in and of itself. Yes, treat the symptom, but don't forget to look for the root cause. In the end, you may be right. Sometimes a cigar is just a cigar. But too many times it's is not!
A program like this is needed in Canada. My daughter was 7 weeks pregnant BEFORE taking Accutane, went for a pregnancy test and was told to go ahead and start taking the drug if she never heard back from the Dermatologist. 10 days passed and she took 13 doses over 26 days and then stopped because she got a rash. 2 months later she discovered she was pregnant. She has since found out that the initial test was positive, but the doctor never called with the results because they went on 10 days holoidays. We definitly need something like the iPledge program here, and I have been in contact with them. As for the health of my Grandson, I guess we will know that in 4 months.
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