FDA Curbs Accutane Dispensal - Tilted Forum Project Discussion Community

amonkie · 08-13-2005, 09:11 AM

I saw this in the paper this morning:

http://news.yahoo.com/news?tmpl=stor...utane_safety_9

Quote:

By LAURAN NEERGAARD, AP Medical Writer Sat Aug 13, 9:54 AM ET

WASHINGTON - The thousands of Americans who take the acne drug Accutane — and people who prescribe and dispense it — must enroll in a national registry, part of a major government program to tighten access to the medicine that causes birth defects.

The Food and Drug Administration enacted unprecedented curbs Friday in trying to keep Accutane and its generic competitors on the market while ensuring that women who use the risky pills don't get pregnant. Critics see it as the drug's last chance, after two decades of safety warnings and other restrictions failed to end Accutane-damaged pregnancies.

"This is a system that has been long in the works and many would say is long overdue," acknowledged Dr. Sandra Kweder, FDA's deputy drug chief. "The responsibility for ensuring that fetuses are not exposed to this medicine is enormous, and is shared by everyone" who takes, prescribes or sells it.

If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. That's a risk for 30 days after stopping the drug, too.

Under the program, every patient — men and women — must enroll in the iPLEDGE computerized registry starting Dec. 31 to receive Accutane or generic versions of the drug isotretinoin.

Doctors must register, too, if they wish to continue prescribing the pills. Drugstores and wholesalers also must register in order for the pills' manufacturers to ship them any supplies.

How does the program work?

All patients seeking a prescription must sign a document informing them of Accutane's risks, including the possibility that it contributes to depression or suicidal thoughts — a warning on the drug's label that FDA also strengthened Friday.

Patients must agree to monthly doctor visits for refills and not to share the pills with anyone. Then the doctor registers each patient into the iPLEDGE database, giving him or her a special identifying code number, and writes the prescription.

But for women of childbearing age, there are some additional steps:

_They must undergo two tests to ensure they're not pregnant in a laboratory or doctor's office before the initial prescription, and monthly pregnancy testing before each refill. Home pregnancy tests don't count. 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 Accutane, and must self-register on iPLEDGE — in addition to the doctor's initial registration — to report that they're doing so. There's no way to know if women lie in this step, but FDA sees it as an additional opportunity to warn of the pills' danger.

The pharmacist must check the computer database before filling a prescription to ensure that patients followed all these rules. Accutane manufacturer Hoffman-La Roche and generic manufacturers will monitor drugstores and wholesalers, and are supposed to cut off violators' sales supplies.

Accutane is supposed to be used for severe acne only, but it is widely acknowledged to be prescribed for more minor cases. The FDA estimates that 100,000 prescriptions for Accutane and generics are filled each month.

"We are very happy that this has happened and wish it had been done years ago," said Dr. Nancy Green, medical director of the March of Dimes.

But the organization, which fights birth defects, will be watching closely to see if the program stops fetal exposure to the risky pill — something tough to do considering the acne drug's chief market is young people, and that half of all U.S. pregnancies are unplanned.

"If it looks like this is a leaky system despite FDA's efforts to really step it up, we may very well call for it to be taken off the market," Green warned.

Since Accutane began selling in 1982, the FDA has reports of well over 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. Critics note there likely were many more pregnancies because doctors haven't been required to report Accutane-linked pregnancies. Friday's new rules mandate that they do.

FDA first attempted to tighten Accutane access in 2001, but the restrictions were largely voluntary and didn't work: The FDA counted 120 pregnancies among the drug's users in the first year of that program, just seven fewer than in the previous year even though overall prescriptions dropped by 23 percent.

The registry actually opens on Aug. 22, giving users extra time to learn how it works before the provisions become mandatory at year's end. On that date, patients may enroll at http://www.ipledgeprogram.com or by phone at 1-866-495-0654.

In addition to the high risk danger of birth defects in pregnancies, there are also other side affects that are still by no means mild:

http://www.fda.gov/cder/drug/InfoShe...retinoinPT.htm

Quote:

What Are The Risks?

* Serious mental health problems : Isotretinoin may cause:
o Depression
o Psychosis (seeing or hearing things that are not real)
o Suicidal thoughts or actions
o Aggressive and violent behavior

* Serious brain problems

* Stomach area (abdomen) problems

* Bone and muscle problems

* Hearing problems

* Vision problems

* Lipid (fats and cholesterol in blood) problems

* Allergic reactions

* Blood sugar problems

* Decreased red and white blood cells

* The common, less serious side effects of isotretinoin are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.

I have battled acne for all of my teen years and still do today - I was offered a chance by my doctor to take Accutane, but I chose not to because of the strong potential for damage to your liver (they require routine bloodwork to check on the liver fuction while you are on the medication) and the hassle of birth control.

Once looking at all the other serious side affects of this drug, it brought me to the real question. What is it about having clear skin that makes it worthwhile to those on the drug to subject their bodies to all these other risks? If the FDA is making attempts to curb usage because of the potential harm, are we doing more harm than good by allowing this product to stay on the market?

Grasshopper Green · 08-13-2005, 11:27 AM

My brother was on Accutane for about six months; the change in him was extremely noticable. He was always prone to depression, but he was constantly depressed as well as short tempered while on this drug. It really didn't do a whole lot for him either. He finally quit taking it due to the side effects. After seeing the effect it took on him, I would be hard pressed to see a good reason to take this. However, I'm not the one who battled acne, and I suppose this question would be better answered by someone who found success using this drug.

analog · 08-13-2005, 11:54 AM

I've been saying for years that they need to do soemthing about accutane- up to and including banning it totally.

A good portion of the people who take it have episodes like what a person with schizophrenia experiences- most of the time to a milder extent, but still, they hear things that aren't real, they see things that aren't real. They generally try not to prescribe it to diabetics because it can screw with a person's bllodsugar so bad- which is a problem for people without diabetese, as well.

The fact is, this isn't a miracle drug. It doesn't cure cancer, or AIDS, or something like that. There are other acne treatments out there... and this one is SUPPOSED TO BE for serious cases, but it's prescribed constantly. Hopefully all this new BS paperwork will make doctors do what they're supposed to do and only prescribe it when it's necessary for a severe case. Any drug that has a definitive, measurable cause of depression, which promotes or causes thoughts or attempts at suicide, violence, and (even "mild") schizophrenia, should be taken off the market or used with EXTREME care.

Gatorade Frost · 08-13-2005, 12:01 PM

I wouldn't go so far as saying "take it off the market", but my sister started it when she turned 19, and she had bad acne for years. Since she was 11-12. I know several people on it, actually, who only suffered through blood tests once a month and really really dry skin for about 3-4 months, but afterwards the effects were startling and worked incredibly well. My sister's visible acne is gone (her skin's bumpy, but not red and noticeable) and it's been great for her.

coleh2085 · 08-13-2005, 12:16 PM

I was on it when I was 13 or 14, took it for 3 months. All I have to say about it is- Miracle Drug. The acne promptly went away and I haven't seen it since! As far as regulating it more closely, that is probably a good thing. Preventable birth defects are a tragedy, and hopefully this system will work better.
Also, I did not experience a single side effect aside from extremely dry skin. I have gone back for regular check ups and lab tests to make sure nothing came up later, and nothing has. Liver function is fine, everything.

snowy · 08-13-2005, 01:24 PM

My best friend suffered from horrible disfiguring acne for years. Finally, after trying everything else--systemic antibiotics, Differin, etc--he decided to give the Accutane a try. His skin got a little worse at first, but within a month or so it cleared up. He only really suffered from dry skin as a side effect, which was easily taken care of with some Cetaphil. His only complaint about the whole experience was that he constantly had to go into the doctor, but I think even that was worth it in the end.

He still has horrible scarring from the acne he had before the Accutane--I'm talking thick, ropy scars on his chest and back. He won't go shirtless because he's paranoid of someone making fun of them (that and he's damn skinny). But it's clear the Accutane made a decided difference, and for someone with disfiguring acne, the side effects of the acne itself can be just as depressing or hurtful as the side effects of the Accutane itself.

Certainly, it's a gamble, but after seeing the difference it has made on some of my friends' lives, I can't say it should be banned. Yes, it should be highly regulated. Like some of the articles I read regarding this said, it's a shame that a few doctors could spoil it for the many who were already following the regulations put in place by the drug companies. The FDA is in the right to step up here and oversee doctors in this way--some of them have already proved too negligent to prescribe Accutane in an effective and safe manner. But trying this kind of oversight will hopefully prevent an outright banning, something I think would be detrimental to the health of many an American.

MSD · 08-13-2005, 02:45 PM

News Flash: Government agency actually does something worthwhile. Story at 10.

I'm not in favor of banning much of anything, but regulating this tightly is really necessary. If I had a hypothetical child who had hypothetical acne, Acutane would be an extreme last resort, and he/she would be closely watched while using it. I've met people who suffered from some of the serious side effects and I wouldn't want anyone going through that.

visotech · 08-13-2005, 10:14 PM

I was on accutane for about 5 months a few years ago...I had no problems with it other then its desired effects (minimalization of my acne!). No reports of any behavior change or liver problems because of it.

Even when I took it, the package was covered in warnings not to use it when pregnant or sexually active...This has been known for years, why the heck are they so paranoid about that aspect now?

Suave · 08-14-2005, 12:10 AM

Quote:

Originally Posted by amonkie

I have battled acne for all of my teen years and still do today - I was offered a chance by my doctor to take Accutane, but I chose not to because of the strong potential for damage to your liver (they require routine bloodwork to check on the liver fuction while you are on the medication) and the hassle of birth control.

I took Accutane, and I was perfectly fine. The only effect I experienced was a complete lack of acne at the end of the period. It was definitely worth it, because god knows how long the acne might have lasted.

irateplatypus · 08-14-2005, 06:31 AM

i would say the possibility of birth defects is very low considering how difficult it is to get laid if you're in need of a prescription.

just kidding folks. i, myself, was on it... twice. only middling temporary results for me.

GeePeeS'r · 08-14-2005, 10:05 AM

I took it for 6 months when I was about 15. I had a "mild" acne problem then - but bad acne ran in my family - my dad and his brother have severe facial scars from it. I never had a single problem with acne since, and pimples were few and far between. The ONLY side effect I ever had was chapped lips. For anyone to say "ban it", you have no idea what you are talking about. Yes, I feel it should be HIGHLY regulated and monitored, but it is a sort of miracle drug. It can make may teens have a much better childhood and life - for many people with acne, the risks are much less than the problems of living with acne.

08-13-2005, 11:27 AM	#2 (permalink)
Grasshopper Green ...is a comical chap Location: Where morons reign supreme	My brother was on Accutane for about six months; the change in him was extremely noticable. He was always prone to depression, but he was constantly depressed as well as short tempered while on this drug. It really didn't do a whole lot for him either. He finally quit taking it due to the side effects. After seeing the effect it took on him, I would be hard pressed to see a good reason to take this. However, I'm not the one who battled acne, and I suppose this question would be better answered by someone who found success using this drug. __________________ "They say that patriotism is the last refuge to which a scoundrel clings; steal a little and they throw you in jail, steal a lot and they make you king" Formerly Medusa

08-13-2005, 12:01 PM	#4 (permalink)
Gatorade Frost Rookie	I wouldn't go so far as saying "take it off the market", but my sister started it when she turned 19, and she had bad acne for years. Since she was 11-12. I know several people on it, actually, who only suffered through blood tests once a month and really really dry skin for about 3-4 months, but afterwards the effects were startling and worked incredibly well. My sister's visible acne is gone (her skin's bumpy, but not red and noticeable) and it's been great for her. __________________ I got in a fight one time with a really big guy, and he said, "I'm going to mop the floor with your face." I said, "You'll be sorry." He said, "Oh, yeah? Why?" I said, "Well, you won't be able to get into the corners very well." Emo Philips

08-13-2005, 12:16 PM	#5 (permalink)
coleh2085 Upright	I was on it when I was 13 or 14, took it for 3 months. All I have to say about it is- Miracle Drug. The acne promptly went away and I haven't seen it since! As far as regulating it more closely, that is probably a good thing. Preventable birth defects are a tragedy, and hopefully this system will work better. Also, I did not experience a single side effect aside from extremely dry skin. I have gone back for regular check ups and lab tests to make sure nothing came up later, and nothing has. Liver function is fine, everything. Last edited by coleh2085; 08-13-2005 at 12:18 PM..

08-13-2005, 01:24 PM	#6 (permalink)
snowy Kick Ass Kunoichi Location: Oregon	My best friend suffered from horrible disfiguring acne for years. Finally, after trying everything else--systemic antibiotics, Differin, etc--he decided to give the Accutane a try. His skin got a little worse at first, but within a month or so it cleared up. He only really suffered from dry skin as a side effect, which was easily taken care of with some Cetaphil. His only complaint about the whole experience was that he constantly had to go into the doctor, but I think even that was worth it in the end. He still has horrible scarring from the acne he had before the Accutane--I'm talking thick, ropy scars on his chest and back. He won't go shirtless because he's paranoid of someone making fun of them (that and he's damn skinny). But it's clear the Accutane made a decided difference, and for someone with disfiguring acne, the side effects of the acne itself can be just as depressing or hurtful as the side effects of the Accutane itself. Certainly, it's a gamble, but after seeing the difference it has made on some of my friends' lives, I can't say it should be banned. Yes, it should be highly regulated. Like some of the articles I read regarding this said, it's a shame that a few doctors could spoil it for the many who were already following the regulations put in place by the drug companies. The FDA is in the right to step up here and oversee doctors in this way--some of them have already proved too negligent to prescribe Accutane in an effective and safe manner. But trying this kind of oversight will hopefully prevent an outright banning, something I think would be detrimental to the health of many an American. __________________ If I am not better, at least I am different. --Jean-Jacques Rousseau

08-14-2005, 06:31 AM	#10 (permalink)
irateplatypus can't help but laugh Location: dar al-harb	i would say the possibility of birth defects is very low considering how difficult it is to get laid if you're in need of a prescription. just kidding folks. i, myself, was on it... twice. only middling temporary results for me. __________________ If you will not fight when your victory will be sure and not too costly, you may come to the moment when you will have to fight with all the odds against you and only a precarious chance for survival. There may even be a worse case. You may have to fight when there is no hope of victory, because it is better to perish than to live as slaves. ~ Winston Churchill

08-13-2005, 11:54 AM	#3 (permalink)
analog Banned	I've been saying for years that they need to do soemthing about accutane- up to and including banning it totally. A good portion of the people who take it have episodes like what a person with schizophrenia experiences- most of the time to a milder extent, but still, they hear things that aren't real, they see things that aren't real. They generally try not to prescribe it to diabetics because it can screw with a person's bllodsugar so bad- which is a problem for people without diabetese, as well. The fact is, this isn't a miracle drug. It doesn't cure cancer, or AIDS, or something like that. There are other acne treatments out there... and this one is SUPPOSED TO BE for serious cases, but it's prescribed constantly. Hopefully all this new BS paperwork will make doctors do what they're supposed to do and only prescribe it when it's necessary for a severe case. Any drug that has a definitive, measurable cause of depression, which promotes or causes thoughts or attempts at suicide, violence, and (even "mild") schizophrenia, should be taken off the market or used with EXTREME care.

08-13-2005, 02:45 PM	#7 (permalink)
MSD The sky calls to us ... Super Moderator Location: CT	News Flash: Government agency actually does something worthwhile. Story at 10. I'm not in favor of banning much of anything, but regulating this tightly is really necessary. If I had a hypothetical child who had hypothetical acne, Acutane would be an extreme last resort, and he/she would be closely watched while using it. I've met people who suffered from some of the serious side effects and I wouldn't want anyone going through that.

08-13-2005, 10:14 PM	#8 (permalink)
visotech Insane Location: San Diego, CA	I was on accutane for about 5 months a few years ago...I had no problems with it other then its desired effects (minimalization of my acne!). No reports of any behavior change or liver problems because of it. Even when I took it, the package was covered in warnings not to use it when pregnant or sexually active...This has been known for years, why the heck are they so paranoid about that aspect now?

08-14-2005, 10:05 AM	#11 (permalink)
GeePeeS'r Crazy Location: Tampa, FL	I took it for 6 months when I was about 15. I had a "mild" acne problem then - but bad acne ran in my family - my dad and his brother have severe facial scars from it. I never had a single problem with acne since, and pimples were few and far between. The ONLY side effect I ever had was chapped lips. For anyone to say "ban it", you have no idea what you are talking about. Yes, I feel it should be HIGHLY regulated and monitored, but it is a sort of miracle drug. It can make may teens have a much better childhood and life - for many people with acne, the risks are much less than the problems of living with acne.