FDA Places Restrictions on Accutane

[merwin]

FDA Places Restrictions on Accutane

By LAURAN NEERGAARD, AP Medical Writer
48 minutes ago

WASHINGTON - Everyone who uses the acne drug Accutane will have to enroll in a national registry, along with every doctor who prescribes it and every drugstore that sells it — tough new restrictions aimed at preventing women from becoming pregnant with this birth defect-causing drug.

The Food and Drug Administration announced the long-anticipated program Friday, more than a year after the agency's scientific advisers urged the extra curbs because repeated safety warnings have failed to stop Accutane-damaged pregnancies.

Both male and female patients will have to enroll in the registry, called iPLEDGE, by Dec. 31 or they can no longer receive Accutane.

Women of childbearing age will have some additional steps: They're supposed to use two forms of birth control, get two negative pregnancy tests before their initial Accutane prescription, and show proof of another negative pregnancy test before each monthly refill.

Women already were supposed to be taking those steps — but using the computerized registry system, doctors and pharmacists are to ensure that that happens. One way: Each month, women will be required to enter into the registry, by phone or Internet, their two contraceptives
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I'm speechless...

[Cobalt Violet]

1. But what if the pharmacist won't fill birth control prescriptions?

:sarcasm: :yoiks:

[Justitia]

4. excellent question in these insane times -eom

[Scairp]

11. I know

This is the first thing that I myself posted when pharmacists refusing to fill birth control pill prescriptions started getting so much attention. Oral contraceptives do not take life in any form; more often than not they save lives.

[jean]

2. do you think the activist pharmacists will balk at dispensing Accutane?

They'll have to grill all the women about their contraception .... WAIT! They shouldn't be on contraception - WAIT! They shouldn't be having sex ... such a tough profession!

[GoBlue]

3. Accutane can make you pregnant.

Everyone who uses the acne drug Accutane will have to enroll in a national registry, along with every doctor who prescribes it and every drugstore that sells it — tough new restrictions aimed at preventing women from becoming pregnant with this birth defect-causing drug.

[TahitiNut]

5. "two forms of birth control"??? What does tne Catholic Church say?

Again, a paternalistic Uncle Sam oversteps his derived authority and oppresses people. Whatever happened to "informed consent" and personal responsibility? This si appalling.

[A Simple Game]

6. tough new restrictions aimed at

preventing women from becoming pregnant with this birth defect-causing drug.

Wow!! A drug that causes pregnancy!!!! Is there a man involved in this at all?

Seriously, maybe they should just ban this drug. I know acne can be devastating to a person, but there are other medications, that are not going to kill anyone.

[LizMoonstar]

8. Accutane is also used in conjunction with some cancer treatments, I think.

[A Simple Game]

10. That makes it a different story.

Now if they can figure out how it causes pregnancy.

[sldavis]

15. exactly right

Accutane's approved indication is severe recalcitrant nodular acne, but it's also been shown to be effective in treating a number of other conditions and cancers, most notably cutaneous T cell lymphoma. Doctors, pharmacists, and (hopefully) patients taking isotretinoin have known for a long time that this drug is teratogenic, and there has been a voluntary registry. The FDA and roche seem to have been dragging their feet in getting a mandatory program together, but with an increase focus on pharmacoepidemiology and risk management in the literature and the industry, there was little else they could do. This is a scary drug for pregnancy, associated with entral nervous system malformations, absence or deformity of ears, cleft palate, cardiac and great vessel defects, and eye abnormalities. Malformations have been seen after only 3 days of therapy in the first trimester. I don't think there's a definite link between congenital anomalies and fathers' exposure, but there have been case reports.

[LizMoonstar]

7. This is standard procedure for Accutane afaik

It is incredibly dangerous to an embryo; it's one of the most defect-causing chemicals out there. Between the damage to the embryo and the damage to the woman, a pregnancy while on Accutane is a very bad thing.
It's creepy the way this is phrased, but anyone on Accutane already knows and does this, so it's a scare tactic article imo.

[merwin]

12. Would you like your child on accutane having to prove that they're

not pregnant every month, as well as be enrolled in a national registry?

I'm all for PARENTS keeping track of their kids, but a national registry is out of the question.

Nearly every prescription drug is very dangerous to an embryo. That's why there's pregnancy warnings on them.

Next step: Make everyone who drinks alcohol or smokes cigarettes prove they aren't pregnant every time they buy.

[MichiganVote]

13. I took accutane years ago. Nothing new in these reg.'s

Other than the registry part its business as usual.

[merwin]

16. The registry and having to PROVE that you aren't pregnant scares me.

That's a violation of your civil rights. I'm not talking about the warning to not be pregnant.

[MichiganVote]

20. The registry w/names is a bad idea but Dr.'s have had to

provide info. about patients taking various high threat meds for years. I took it years ago so it doesn't affect me now. A pregnancy test had to be taken each month of the medication to assure that one was not pregnant.

[meganmonkey]

9. jesus christ on a zit

How in the world would someone be willing to take something this toxic??

I don't understand this. If it causes birth defects in pregnant women, it is POISONOUS and dangerous and we all know damn well by now that just because it is FDA-approved does NOT mean a sane person should take it...

I don't get it. I don't mean to sound insensitive to people with severe acne - but severe acne won't damage a person the way a drug like this can.

[Mairead]

14. Wasn't tetracycline meant to be a real acne-killer?

I thought I read that.

[hallc]

18. it was...

Until the bacteria that causes acne became resistant to it. Accutane basically dries up your sebaceous glands and stops your pores from being clogged at all - thus stopping the trapping of bacteria and all the nasty pus and junk. Its really not that dangerous for people to use, it is only dangerous if a woman gets pregnant. The worst side effect is that of suicidal thoughts, but hell, even anti-depressants give you that. I for one am on accutane and it is a life saver. To be in your mid-20's with acne, not only on your face, but all over your body, is very humiliating. I thought this was something people went through when they were in highschool, but mine didn't show up until i was almost finished with my undergrad. Finally, i decided enough was enough, and i went on Accutane. Within 2 months of my treatment, i have been acne free. I have 4 more months of treatment left, and while it does make me extremely dry (i.e. cracked lips, dry eyes) it is nothing that I can't handle. So to all of you who think we should just "live" with acne, you obviously never have.

[AngryAmish]

19. Talk to someone with recalcitrant acne

I'm not talking about the occaisional whitehead. Large cystic acne that turns purple.

I have never had that problem but I knew people who have. Very bad acne can cause strangers to recoil from looking at you. Your job prospects go way down and finding a mate is next to impossible.

I have seen accutane work wonders. These restrictions seem to be commen sense.

[hallc]

22. Thank You

I love how people can judge something (or someone) without understanding the circumstances behind it. Accutane has been a godsend for me...Before, I had to use so much makeup to cover up my cystic acne, and i had a huge self esteem problem (call me shallow, vain, whatever...). Accutane gave me freedom from the stares and the PAIN - anyone who has had cystic acne knows what i am talking about.

[AngryAmish]

24. I'm glad to hear you are doing well

My sister had terrible cystic acne for years. They do hurt a lot. Accutane has done wonders for her. Unfortunately, she still has scars.

One is not shallow or vain to not want to be looked at as a freak. Everybody wants a nice job and a good significant other. It is human nature.

Good luck.

[merwin]

23. The restrictions are fine. Having to PROVE to the government that you're

not pregnant and on birth control is NOT fine.

[MichiganVote]

21. Radiation is poinsonous too but cancer patients are healed by it

[alkaline9]

17. let me get this straight...

...you MUST prove (to the government) that you are on birth control (of some sort) to take this drug... which could potentially save lives (cancer treatment).

Yet stem cell research... which could potentially save even more lives... is not funded by the government because it goes along with birth control (of sorts)?

I don't see this ending well....

[KatyaR]

25. Trust me when I say this is a GOOD thing . . . .

I took Accutane for 4 months back in the 80s. I had cystic acne, I guess they call it, where I would have huge cysts on my face and back. It was miserable, and nothing would help it.

There were restrictions back then, too. You had to be on birth control no matter if you were sexually active or not, and you were warned many times about the VERY HIGH risk of birth defects. It was really scary for someone in their 20s, but I was desperate to get rid of this horrible acne (my mother was in her 60s at the time and still had them), so I went ahead with it.

My dermatologist failed to ask me if I wore extended-wear contacts, which I did. Not long after I started taking the drug, I woke up one morning and had one eye totally dilated and the other almost as bad. My opthamologist thought I had a highly contagious eye disease until I told him I was on Accutane, then he explained to me that the drug dries up the skin and mucous membranes, and that's what had happened. I was absolutely miserable with pain for two days until my eyes got better--I couldn't stand light or sound or dark or, well, anything. It was absolute torture.

So I got over that, and my skin started getting better. I was so excited--for the first time in my life I had a clear face. But then the side effects kicked in.

I couldn't sit for any amount of time without becoming so stiff that just standing up was an effort. I had to pull myself up, and it hurt to get up from the chair. When I was in bed, I had the same stiffness--it was almost like having cerebral palsy. I couldn't turn over without having to grab the mattress or sheets and pull myself into the position I wanted. The skin on my face became so thin that the slightest pressure would leave a mark or actually break the skin. The membranes in my nose dried up so badly that I was stopped up and had nosebleeds every day. And I couldn't wear my contacts, so I had trouble seeing. I was freaking miserable, and that's an understatement.

Finally, after four months, my skin was relatively clear, so I said to hell with it. It's not meant for long-term use anyway, but I couldn't stand all the pain I was going through.

Yes, it definitely helped the cystic acne--I still have problems but nowhere near as badly as before. However, to this day, the inside of nose is totally messed up. I have constant inflamation, and my nose is always stopped up. The skin on my face is still very thin, although not as bad as it was when I was taking this medicine. It feels like the texture of the skin actually changed somehow.

I guess it was worth it for me, but I do not recommend it for anyone else. You have to have a physician who is really aware of the risks, counsels you about those risks, and monitors you like crazy.

Accutane is WAY dangerous--as far as I'm concerned, it should be taken off the market.

That's just my story.