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What Price Beauty? (Accutane hit piece alert)
The Boston Globe Magazine ^ | 4/27/2003 | By Ellen Rafshoon

Posted on 05/02/2003 9:04:41 PM PDT by Paleo Conservative

Edited on 04/13/2004 2:09:43 AM PDT by Jim Robinson. [history]

Although Accutane causes birth defects, many acne sufferers love the way the miracle complexion pill makes them look, and so do their doctors. That's why it has become the most widely prescribed birth-defect-causing medicine in the United States.

Many women might be reluctant to reveal their vanities, but Brenda McCoy boldly admits that she's always been concerned about her looks. "I take really good care of myself," says the svelte Orange County mother of four and part-time nurse who's finishing work toward her bachelor's degree at California State University. Despite her hectic schedule, the 40-year-old maintains her figure by running, biking, and power walking.


(Excerpt) Read more at boston.com ...


TOPICS: Culture/Society; Extended News; Government
KEYWORDS: accutane; acne; dermatology; dontfallasleep; drugs; fda; medicine; regulation
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To: Calpernia

This works wonders.

81 posted on 05/03/2003 11:10:12 AM PDT by kcvl
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Comment #82 Removed by Moderator

To: Motherbear
If she is on accuntane long term than she should be a pile of dust. The drug shrinks your sebaceous glands and dries you out.

Her issue is with a bad doctor. Any and all drugs can be used and prescribed negligently by a bad physician. The physician is the problem.

Someone could take a pencil and shove it up their nose. Should the pencil maker be sued for making a pencil that could be inserted into an idiot's nose?

This kind of stuff will not stop until there is tort reform. Accutane has boundaries for its use, although it is highly effective. The woman in this article has a bad doctor, she doesn't have a problem with the drug.
83 posted on 05/03/2003 11:18:27 AM PDT by diotima (FR/FRN SUPPORTS OUR TROOPS!!!!!!!!)
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To: Paleo Conservative
Warning about Pregnancy Risks

When FDA approved Accutane, the drug was known to be teratogenic--able to cause birth defects. It was designated as Category X, meaning that it must be avoided under all circumstances during pregnancy. Nursing mothers also should not use Accutane.

Though not every fetus exposed to Accutane becomes deformed, the risk of birth defects among pregnant women is extremely high. These defects include hydrocephaly (enlargement of the fluid-filled spaces of the brain) and microcephaly (small head), heart defects, facial deformities such as cleft lip and missing ears, and mental retardation.

Reports in the literature suggest that about 25 to 35 percent of babies will suffer a malformation after exposure, and that doesn't account for other defects, such as learning disabilities, that aren't detectable at birth. Miscarriages and premature births have also been reported.

Though FDA approved labeling in 1982 that warned Accutane should not be used in pregnant women, reports of severe birth defects associated with the drug began to arrive in June 1983. Over the following years, a series of labeling changes and letters to pharmacists and prescribers of the drug stressed pregnancy warnings and sought to increase awareness about reported malformations.

Then, after an FDA review of pregnancy exposures to Accutane, Roche launched the Pregnancy Prevention Program (PPP) in late 1988 to further educate women using Accutane and their physicians about the dangers. The goal was to ensure that prescriptions would only be given to women with severe recalcitrant nodular acne who could comply with contraceptive requirements.

Roche sent PPP kits to physicians and encouraged them to review pregnancy prevention materials with patients before starting the drug. Materials included a contraceptive booklet, checklists to help assess whether patients could adhere to the drug's requirements, and consent forms that patients sign to acknowledge their understanding of the risk of birth defects. Roche also set up a toll-free line, made contraceptive information available in 13 languages, and offered to pay for contraceptive counseling and pregnancy testing by a specialist.

To further reinforce pregnancy prevention, Roche began packaging Accutane in blister packs that include red and black warnings, along with a drawing of a malformed baby and the "Avoid Pregnancy" symbol.

Even though Accutane's labeling recommended use of two reliable forms of contraception, there have been reports of pregnancies occurring in patients who used hormonal contraception, including pills, injectables, and implantables, while taking Accutane. Accutane's labeling was updated in the summer of 2000. One change emphasized the need for two reliable forms of contraception for at least one month before taking Accutane, during treatment, and for one month after discontinuing Accutane, even when one of the forms of contraception is hormonal.

84 posted on 05/03/2003 11:20:47 AM PDT by kcvl
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To: Paleo Conservative
After reading this thread, as well as that long list of side effects, I think I personally would prefer to have acne. The side effects seem MUCH worse (rectal bleeding, seizures, joint and back pain, etc.) than acne. True, I'm lucky to have never had problems with acne. But do ProActiv and Dermafina not work? Is there really no other way?
85 posted on 05/03/2003 11:34:19 AM PDT by Fraulein
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To: Fraulein
For legal reasons, the drug companies have to list every possible side-effect, no matter how improbable.

I think joint pain may be the most common side effect you mentioned but rectal bleeding and seizures are really rare. I had one nose bleed, really chapped lips and very dry skin for a few months afterwords. My skin stabilized about a month after I completed the course and I have had no other side effects.

The next time you get a presecription filled, read the insert about the drug...many many side effects are listed that are possible but not probable.

If you have skin problems or want a great exfoliation: take six uncoated aspirin tablets, dissolve them in a table spoon of hot water, use as a mask for about five minutes and wash off. Very effective. Very cheap.
86 posted on 05/03/2003 11:42:01 AM PDT by diotima (FR/FRN SUPPORTS OUR TROOPS!!!!!!!!)
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To: Motherbear
I remember half my friends' kids were on accutane, and they NEVER had severe acne....just a few breakouts here and there. That's bad medical practice, imo. I did have one child with severe acne, and she was put on accutane and became extremely depressed. Thankfully, her acne cleared up and she did not have to stay on it. Usually, the acne clears up enough that girls don't have to stay on it.

Read bonesmccoy's reponse #41 He does not prescibe the drug; he refers patients to dermatologists. I don't think accutane should be used if other therapies work. It is a drug of last resort, but the decision about whether to go on it should be made by the doctor and patient, not some bureaucrat in Washington DC.

87 posted on 05/03/2003 11:42:24 AM PDT by Paleo Conservative
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To: kcvl
This works wonders.

Mileage can vary.

88 posted on 05/03/2003 11:46:46 AM PDT by Paleo Conservative
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To: Motherbear; diotima
I agree with you, but obviously the drug is being used long term by this woman. Most people who go off of it seem to have a return of "some" acne, but not the full blown case of acne as before. She's staying on it so her skin can "glow"?

One of the side effects is that it makes the skin redder. It actually makes the skin look sunburned rather than healthy. The red color is due to the similarity between accutane, vitamin A, and carotenes. Carotenes are the pigments responsible for yellow and orange colors in plants and vegetables.

89 posted on 05/03/2003 11:52:09 AM PDT by Paleo Conservative
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To: Hildy
the drug was known to be teratogenic

I used "face cancer" when I thought accutane was in some kind of cream you'd smear all over your face ---but I wouldn't like to put anything teratogenic in my body or all over my body. What's the difference between teratogenic and carcinogenic? They're all mutagenic meaning they cause damage to DNA. And birth control pills aren't all that safe either when you see the number of patients using those who end up with coagulation disorders. I wonder what happens when someone takes both together?

Maybe I go too far the other way --but I won't even use tylenol. All those chemicals have some side effect I'd just as soon stay away from.

90 posted on 05/03/2003 12:54:45 PM PDT by FITZ
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To: FITZ
Not even Tylenol, huh? This is how I look at it... life is too short... if I don't have to be in pain, I won't. That's just the way I feel.
91 posted on 05/03/2003 1:02:11 PM PDT by Hildy
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To: Hildy
I admit --I might take it too far --but then again I have no pain so really have no need to take even tylenol. If I get a headache it's from lack of caffeine so all it takes is coffee. I think a high school age person could be pressured to take something she might later on wish he/she didn't take ---I didn't have acne though so I don't really know frustrating it could be.
92 posted on 05/03/2003 1:14:47 PM PDT by FITZ
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To: Calpernia
If a woman gets pregnant 5 to 10 years after she's been on accutane, is the child still at risk?

Just wondering because the article doesn't make that clear and I was under the impression that once you're off of it, you're fine.

I was one of those people who talked my dermatologist into prescribing it to me for a few pimples...and after much convincing he was militant about pregnancy tests and birth control.

It takes a special kind of stupid to risk getting pregnant after being told the consequences of taking that drug but I don't think that everyone should be punished because of the low bar that they set.

Best Regards,

93 posted on 05/03/2003 1:40:01 PM PDT by scoopscandal
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To: Hildy
I'm done on this thread. My points are there. Take them or not, your choice.

Your reply to my post number 4 was out of line. But you already know that. ciao.
94 posted on 05/03/2003 4:37:58 PM PDT by Calpernia (www.HelpFeedaChild.com)
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To: scoopscandal
If a woman gets pregnant 5 to 10 years after she's been on accutane, is the child still at risk?

According to the WebMD.com website, which I previously linked in post #36, no. WebMD.com says one month; others say three months, but it is not years.

Do not take isotretinoin if you are pregnant or if you could become pregnant during treatment or for one month after you stop taking isotretinoin. Isotretinoin is in the FDA pregnancy category X. This means that isotretinoin is known to cause severe birth defects in an unborn baby. It can also cause miscarriage, premature birth, or death of the baby. You must take a pregnancy test and have negative results when you and your doctor decide that isotretinoin may be beneficial for your condition. You must have a second pregnancy test with negative results during the first 5 days of the menstrual period right before you start taking isotretinoin. Two reliable forms of birth control must be used at the same time (unless abstinence is the chosen method of birth control or if you have undergone a hysterectomy) for one month before starting treatment with isotretinoin, during treatment with isotretinoin, and for at least 1 month following the end of treatment. You will also be asked to take a pregnancy test on a monthly basis. Your doctor will discuss with you and provide for you a video and written information regarding choices for birth control, possible causes for birth control failure, and the importance of using birth control while taking isotretinoin. If you become pregnant, stop using birth control, or miss your menstrual period, immediately stop taking isotretinoin and notify your doctor.

95 posted on 05/03/2003 8:12:01 PM PDT by Paleo Conservative
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To: Paleo Conservative
Time to put on my Dermatologist hat again. I've been prescribing Accutane for 18 years since my residency under the second US doctor to use it in research. It is a miracle drug for those who really need it, the patient with severe nodulocystic acne that has flunked the many other standard, usually effective, treatments for it. These are not your average teens who think they have bad complexions, but rather folks with a potentially life ruining condition. Those that say they should learn to live with such severe acne without treatment are the ones who need the shrinks; their statements are cruel and inappropriate. One standard full dose 4-5 month course of accutane with clear the vast majority of them. More than a third will be permanently cured. The rest tend to recur 6-12 months later with much milder acne than before, which usually responds well to the standard safer treatments they'd previously flunked. 10-15% will have enough recur to require second (and rarely more) courses. The justification for the risks of Accutane is its unique ability to permanently cure or at least downgrade acne in patients otherwise doomed to severe scarring. Low doses of accutane will suppress acne, mild, moderate or severe; however only the severe cases receive the long term benefits and only then with full dosing. Long term low dose accutane therapy just maximizes medical side effects. People with non-severe acne, like this McCoy, will have all their acne return soon after stopping accutane. They can be much more safely maintained on other medications with reasonably good control. For those with unrealistic expectations (like McCoy) the shrinks can have them. IMHO they should not have accutane, the risks are just too great - to me and society! They may convince dumb attorneys, journalists or politicians to go after me or the drug company in ways that endanger the ability of the patients who really need accutane to receive it. There have been well organized groups trying to remove accutane from the market for years and the McCoys of the world are not worth the risk of empowering them.

The most important side effect is birth defects, which a little bit of accutane at the wrong time has a good chance of causing. Fortunately most patients should be male. Although it's tempting to completely exclude females from the drug Congress would never accept that and there are some women who really do need the drug. Accutane is NOT stored in the bodies of men or women and is probably all out of the system within a couple weeks rather than the months suggested upthread. That poster may have worked for Roche on accutane, but her memory is factually incorrect on this point. Pregnancy is permitted one month after the last dose without any drug related risks. Accutane is NOT a mutagen, that is it does NOT damage DNA or chromosomes. It IS a potent teratogen; that is to say it damages developing organs while they are growing. Accutane doesn't damage sperm and having the father on accutane doesn't damage the fetus; presumably not enough accutane is transferred via sperm to the mom to cause any problems in her.

The challenge in preventing birth defects is to avoid pregnancy for 6-7 months, the standard course and one month either side of it. The drug companies have excellent plans for avoiding that if doctors and patients would just follow them. If they can't follow the plans they (doctor or patient) shouldn't use the drug. Adequate and properly timed pregnancy testing avoid starting accutane on someone already pregnant. Monthly pregnancy testing thereafter won't directly prevent pregnancy, but it should remind them of the need to avoid it. I checked my literature today and hysterectomy IS acceptable as sufficient contraception. Lesser sterilization (tubals or vasectomies) are not sufficient contraception. I'm not sure if being proven post-menopausal is sufficient, but realistically post-menopausal women won't need accutane. Absolute abstinence is deemed sufficient contraception and of course it always works when it is really done. The trouble for Dermatologists, just as for parents, is how well can you believe the girls on this subject. I send all my female accutane patients to the Gynecologist for contraceptive counselling, for which Roche will pay, hoping they can recognize those girls lying to their parents and me both. Another risk with trusting abstinence alone is these girls may not have been able to get dates because of their acne, but may start dating and sex as they improve. Other than absolute abstinence or hysterectomy the acceptable contraception options require at least two forms of primary or secondary choices with at least one being from the primary list. Primary choices: Combination oral contraceptives, Norplant, injectable hormonal contraceptives, IUD, surgical sterilization (male or female partner), hormonal vaginal contraceptive ring. Secondary choices: condoms+spermacide, diaphragm+spermacide, cervical cap. I've not had any accutane pregnancies so the above seems to be working for me. The biggest advantage the new SMART plan added was requiring doctors to register for it before they could prescribe the drug. That should stop many doctors who rarely prescribed it and who were ignorant of when and how to use it from causing problems. They'll refer the patient rather than deal with the extra paperwork. Alas there will always be some bad apples in medicine as in all other fields. Even if the FDA banned accutane there would be problems as a black market in accutane would soon develop.

The most common side effects result from accutane shrinking sebaceous glands to almost nothing. Dry skin is usual and chapped lips is universal. Dry eyes and dry nasal mucosa is also common. This generally reverses completely after stopping treatment. Those whose acne never recurs still go back to being as greasy as they were before accutane within a year after stopping treatment. About 20% have various musculoskeletal aches and pains, which generally resolve a week after stopping therapy. In my experience athletes are more apt to complain of such, but I warn all patients of the possibility. Some may wish to schedule their course outside of their main sport's season, but most seem to tolerate this as a price for clearing their faces. Blood tests are followed for potential blood, liver and lipid problems, but other than raised triglycerides such problems are rare. I've only had one patient who had to stop treatment because of lab tests. There is a long list of miscellaneous side effects that are rarely significant problems. Realistically if their acne was severe enough most kids will tolerate the dryness and aches and otherwise tolerate accutane well.

Depression, potentially leading to suicide, is the other "side effect" the media, lawyers and politicians talk up. Whether or not it is a true association is questionable and I caution my fellow freepers to process claims of accutane depression the same way they process many other claims from such sources. Depression is extremely common in teens and suicide is the number three cause of death in teens (after accidents and homicide) so a fair number of cases could still be chance associations. It is likely that many accutane patients would be depressed by their bad faces before treatment ever started. In my experience for most patients accutane is the best "happy pill" available, they are uniformly delighted by the change in their skin. Multiple retrospective studies show significantly less depression in accutane treated patients than in acne patients in general. IIRC the number of suicides reported to Roche over the history of the drug is about one tenth that would be expected by chance. Perhaps it has been under reported, but I doubt teen suicides have been under reported that much. Also accutane works through the vitamin A pathway; its effects and side effects generally parallel those of vitamin A overdoses. Depression is not known to be a vitamin A side effect and no one has suggested any other way accutane could cause depression. To be up front I have had three patients who became depressed while on accutane, one of whom spent one night in the psych unit. All three elected to finish their accutane and did well on all counts. As I have loads of depressed patients they may well be chance associations. Depression "from" accutane became politicized after Congressman Stupak's (D-MI) son committed suicide IIRC one month after finishing accutane. His parents have seized on accutane as the cause to the exclusion of all else and realistically aren't going to change their minds no matter what evidence is supplied to the contrary. Having lost a cousin to suicide I can understand their grief even though I question their conclusions. Unfortunately Stupak is on the subcommittee overseeing the FDA so his concerns can have real effects on the availability of the drug. The other case that pushed the media's concern over depression was the kid who flew a plane into a Tampa building. They have sued Roche, but almost certainly he hadn't taken a single pill of accutane yet. The only depressing thing about his case is that a lawyer would take it.

The article talks about potentially increasing the restrictions on accutane to match those placed on thalidomide. That would be a terrible change. Although thalidomide is useful for many skin diseases that are otherwise difficult to treat, I'll never be able to prescribe it. My one doctor, one nurse office just doesn't have time to deal with the hours of paperwork required. Many pharmacies wouldn't be able to deal with the required paperwork at their end either. If accutane were similarly regulated I'd have to stop offering it and send all my patients requiring it an hour away to the University of Iowa. They are probably the only Dermatologists in the state in a group big enough to deal with such paperwork. Many other rural states would have similar problems. The current restrictions are workable and are fairly reasonable.

96 posted on 05/03/2003 10:03:18 PM PDT by JohnBovenmyer
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To: JohnBovenmyer
Thanks so much for your informative post.

Since my daughter has tried every other treatment for acne and the dermatologist has recently suggested accutane, the information is quite helpful and timely in helping us to make our decision.
97 posted on 05/12/2003 8:25:34 AM PDT by birdwoman
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Comment #98 Removed by Moderator

To: moving lights

http://www.freerepublic.com/focus/f-news/904958/posts?page=34#34


99 posted on 05/30/2006 2:28:54 PM PDT by Calpernia (Breederville.com)
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To: rmlew
There are cosmetic reasons not to take Accutane. The active chemical in Accutane is a derivative of Vitamin-A, Isotretinoin. Isotretinoin causes hairloss. If you want to use a Vitamin-A derivative on your face, use Retin-A (tretinoin), which does not have this effect.

Or if you want address acne effectively, and on the cheap, go to your local vitamin aisle and buy one bottle of Vitamin A, and one of zinc tablets.

Take one of each daily (at night, as zinc can sometimes cause stomach discomfort).

Dunno if it works well for everybody, but it's worked well for everybody I know who's tried it.

100 posted on 05/30/2006 2:36:52 PM PDT by r9etb
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