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i went to my derm today and he said that every derm in the us CANT prescribe accutane anymore cuz ppl had serious birth defects.

wtf, stupid. it says dont get preggerz. don't sue a company if you just can't get the fugging picture.

ugh. so no more accutane for me...he said it should all be cleared up by next week, but i'm not sure...just wanted to let you guys know about this.

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sorry, he didn't explain it that well into detail. but, yesterday, they decided to shut accutane down. he said that they'll have the whole situation cleared up (i don't know, maybe temporary, maybe not) sometime next week, HOPEFULLY. he wasn't entirely sure.

stupid pregger ppl on accutane decided to sue accutane cuz of the birth defects. so now the fda or something decided to shut it down entirely in the US.

you probably didn't hear about it yet cuz it just happened yesterday.

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wow, this is crazy. is it on the news and everything? i remember what a huge deal it was when they recalled vioxx, i got a letter because i was on it at the time. will they send us all letters?

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I do not believe that "yesterday, they decided to shut accutane down."

There is absolutely no news of this anywhere. This is bad information.

My guess is this guys derm didn't do some of his Ipledge paperwork and now he can't prescribe any 'tane till he gets his paperwork sorted out.

The sky is NOT falling.

-30

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OMG, for all you in the us of they do stop accutane, how many peoples dreams will be crushed. im in the uk, hope they dont start over here

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Agreed FireGurl.

This is NOT true. There is no news anywhere that anything interesting at all has happened with accutane and it's various generic brands.

These drugs make these companies a LOT of money, something like this does not happen without a significant media presence. Guys derm is an asshat. Please don't propagate the unfounded hype.

-30

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30 something is right.

Or you can back it up with legitimate concerns.

There should be plenty of media uproar, at least on CNN, or at least in some sort of even an obscure website.

Would have easily heard this ALL OVER the presecription board if this was the case.

Take your free time elsewhere and play with it.

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I agree...your info is BAD...I think you need to get a new Derm!

Here is a quote from the FDA Website about IPledge:

FDA News

FOR IMMEDIATE RELEASE

P05-52

August 12, 2005

Media Inquiries:

Susan Cruzan, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

Revised October 28, 2005: The implementation dates of the iPLEDGE program have been revised. The date by which wholesalers and pharmacies must be registered /activated in IPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE can prescribe isotretinoin and only patients registered and qualified in iPLEDGE can be dispensed isotretinoin. Patients can begin registering and qualifying on December 30, 2005.

FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane) for Treating Severe Acne

The U.S. Food and Drug Administration (FDA) is announcing approval of a strengthened distribution program for isotretinoin, called iPLEDGE, aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the drug. Isotretinoin (Accutane and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy.

The manufacturers are implementing a program that requires registration in iPLEDGE by doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use the drug. These measures are designed to guard against pregnancies while using the drug. Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense the product. FDA is approving this program under its regulations, known as Subpart H, that require restrictions on the distribution of a drug to assure safe use.

"This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin." said Dr. Steven Galson, Director, FDA's Center for Evaluation and Research. "iPLEDGE, using a computer-based and telephone system, will provide health care professionals with the real time information necessary to effectively manage the risks of isotretinoin."

In February 2004, at a joint meeting, FDA's Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee reviewed the existing isotretinoin risk management programs in effect at that time. Based upon their review, the joint committee called for major improvements in the restricted distribution program, including mandatory registration to ensure that patients who could become pregnant have negative pregnancy testing and birth control counseling before receiving the drug.

To inform health care providers about iPLEDGE, FDA has issued a Public Health Advisory and revised the Patient and Health Care Provider Information Sheets that detail the tightened restrictions and increased responsibilities under iPLEDGE for prescribing, dispensing, distributing, and obtaining isotretinoin.

To obtain the drug, in addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy testing.

A reporting and collection system for serious adverse events associated with the use of istotretinoin has also been implemented. All pregnancy exposures to isotretinoin must be reported immediately to the FDA via the MedWatch 1800-FDA-1088 and to the iPLEDGE pregnancy registry at 1-866-495-0654 or on the iPLEDGE website.

Doctors, patients, and pharmacies can obtain program information and register with iPLEDGE via the Internet at www.ipledgeprogram.com, or telephone 1-866-495-0654.

In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin.

Under the program, wholesalers and pharmacies will have to be registered with iPLEDGE, effective December 30, 2005, to obtain isotretinoin from a manufacturer. Starting March 1, 2006, all patients and prescribers (doctors) must be registered and comply with requirements for office visits, counseling, birth control and other responsibilities.

The manufacturers participating in the iPLEDGE program include:

Hoffman-LaRoche manufacturer of Accutane; Genpharm manufacturer of Amnesteem which is distributed by Mylan/Bertek; Ranbaxy Pharmaceuticals manufacturer of Sotret; and Barr Laboratories manufacturer of Claravis.

For additional consumer information, visit the following website: http://www.fda.gov/cder/drug/infopage/accutane/default.htm

Here are the links if you want more info:

FDA Info on Accutane

IPledge Program Website

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thats funny. How could they not prescribe it anymore because of birth deffects? Don't they already say not to use 'tane if pregnant or planning on it?

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Here's why either you misunderstood your derm or he is full of BS.

In the Vioxx trials, tons of lawsuits were logged as Vioxx did not come with any serious warnings of heart attack and stroke. The drug was taken off the market in 2004 and there are STILL trials going on. There was also tons of hype leading up to the removal of the drug, including the FDA issuing a warning against the drug and many public announcements made about the danger of the drug.

In our case, we are required to register with a national pregnancy awareness group, we receive the warnings from the FDA multiple times before we are even written the prescription, we are only allowed to be prescribed the drug by a specifically licensed dermatologist, dispensed the drug by a specifically licensed pharmacist, we must be on 2 forms of birth control, have our blood taken monthly, and furthermore, we are only given one month's worth of the drug at a time.

My dad is a physician who prescribed Vioxx to MANY patients - it worked wonders for rhematoid arthritis. I took it for hip problems. He could give prescriptions to patients for a years' worth, if he wanted. He was not specially licensed to dispense it (other than his years of medical experience and the MD behind his name), nor were the pharmacists (other than their obvious qualifications as well). These patients never signed a waiver, and because the companies were not aware of such serious risks, they never agreed to take the drug in spite of those possible complications. It goes without saying that when you take a medication you are likely to have side effects, but no one thinks they will be that serious. It might have been a possibility, but for it to happen to multiple people, as it happened with Vioxx, it became more serious. (I still don't agree with taking it off the market... that drug was simply incredible. But I digress.)

Now tell me, what more could the FDA do to protect us from ourselves? Those women who get pregnant and sue the company are JUST PLAIN STUPID. They will NEVER win their lawsuits - they are required to sign all the paperwork saying that they understand the risks and that they will not get pregnant. When THEY violate their contract, they cannot hold the company legally liable.

SO. Accutane won't be taken off the market. And if it were, we, as the current takers of accutane, would have known about it a long time ago. We would be receiving letters, calls from our dermatologists, calls from mass tort lawyers hoping we would sign with them to sue, etc. And ESPECIALLY... it wouldn't be "cleared up by next week." That is total crap. I have never heard of a medicine being taken off the market then being put back on next week. The FDA makes SURE that any drug on which they put their seal of approval is worthy of that seal. That means there are years and decades of trials they put the drug through to make sure it is safe for humans, so that mess-ups like the Vioxx (if you could call it a mess-up) that slip through are very few and far-between. Our drug comes with heavy warnings, and those who ignore those warnings, well... what can you say? We won't be punished for that.

Long post, I know. But I just wanted to help reassure everyone.

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there is a new LAW that you MUST get a pregnancy test before you can take the drug

however, that does not mean lets not give people accutane anymore.

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i don't know...he sounded pretty serious at the time and stuff and all the nurses at the clinic were going crazy. i don't think my information is BAD..thats a pretty damn strong accusation.

i'm sorry if i made you guys all pmsy - i kno you're all on accutane and i thought i was being nice by sharing this with you and all i get is "YOUR EFFING INFO IS WRONG" and "WTF IS YOUR PROBLEM".

w/e, i guess i just won't alert you guys anymore with details.

sorry for the trouble then.

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You don't think your information is bad?

There isn't a shred of evidence to support the idea that accutane's been prohibited. Let's see, 9 days after they introduce iPledge, a specific system designed to control pregnancy while on accutane, they decide to go ahead and ban it instead, ~25 years since its inception.

Either your derm is a moron or you're a wind-up merchant.

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i don't know...he sounded pretty serious at the time and stuff and all the nurses at the clinic were going crazy.

I bet they were freaking out since it sounds like their boss probably messed up something that he shouldn't have. Either that or he's just a first class jack ass all the time.

i don't think my information is BAD..thats a pretty damn strong accusation.

It's not an accusation at all, it is a fact that. Your information is bad (on many levels) but mostly it's just completely inaccurate.

i'm sorry if i made you guys all pmsy - i kno you're all on accutane and i thought i was being nice by sharing this with you and all i get is "YOUR EFFING INFO IS WRONG" and "WTF IS YOUR PROBLEM".

When you come completely out of nowhere with dooms day information that is completely untrue you should expect a little backlash. Sorry if you found yourself being attacked. It certainly wasn't my intention with pointing out that what you were saying was not true. My intentions were to assure all the people that were reading your post that they had nothing to worry about. Which is true, unless they have your derm apparently.

w/e, i guess i just won't alert you guys anymore with details.

If the level of fact checking that goes into your alerts is always this low, then that's probably a good idea for your sake and ours. Seriously a ten second search on google news would have told you that this was not happening and this whole thing could have been avoided.

sorry for the trouble then.

No worries.

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30something - hahahahahahahahahahahahahaha

I was cracking up at your whole post. And by that I mean I was actually laughing out loud. You rock!

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to ClearSkinForever: I don't think anyone was trying to attack you, just correct the misinformation. But, if you have been taking Accutane and your derm just screwed up by telling you its being taken off the market, and now you found out that is not true, don't you wanna call your derm and ask what they were talking about? If it were me, I would call my derm NOW and politely ask why they cannot prescribe it (iPledge, or whatever), and EXACTLY when they plan to be able to prescribe it again, and get a definite answer. Otherwise, I would look for a new derm. If you have already begun your treatment (on your way to clear skin! YAY!), doesnt it bother you that you have to stop? I would just be a bit more aggressive about trying to get my prescription!!!

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i'm sorry if i made you guys all pmsy -

Why must you assume it's a FEMALE reaction? It was equally responded to by both males and females. Perhaps you started feeling stupid for not checking your facts and then decided to make it in to our problem...and a hormonal one at that. Brilliant.

No one was attacking you personally, it's just not something you put on an ACNE.ORG forum without being sure it's credible! Talk about a way to open a can of worms...yikes. No one was mad at you, it just would have been better if you checked a few places before declaring that the sky was officially falling for thousands, perhaps millions, of people who live and die by the hope Accutane has given them.

All I ever said was that your INFO was bad, and you should get a new derm. Not sure how that could be taken as a personal attack. You certainly didn't mean to do harm, but you can't expect people not to be up in arms. So don't try to make it our fault! It's over with.

Anyway, it's behind us now and no hard feelings. ;)

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