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ACCUTANE
March 24-26:
June 2004
Sites I Read Weekly
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May 2004
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Alan N. Moshell, MD, director of the skin diseases branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, says he’s heard about severe adverse effects such as liver damage in cases where a full dose of Accutane has been prescribed with inadequate follow-up. “It has usually been a situation in which the full five-month course has been prescribed at the first visit and then the patient was not brought back, or simply failed to follow instructions about follow-up visits and blood tests.” In such cases, patients may keep taking the drug and only return to the doctor when it’s too late and they’ve experienced an adverse effect.
Tue
© Copyright 2008 Julie Wiggins.
23
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I really don’t know how much longer I can handle this and honestly if my acne reoccurs after this treatment..I don’t think I will ever want to go through this again…I can live with acne. Plus at this point, its affecting my job..my boss doesn’t believe I’m sick and I am in so much pain with my back and kidneys..that its an effort to get up everyday and go to work, the painkillers help – but really who wants to be on painkillers on top of all the other drugs I’m taking for every other infection that pops up because I’m so dried out..vitamin E to combat the dryness, painkillers for my back, the accutane for the oil/acne, water and more water and still can’t pee..I feel like a little old lady that has to take 20 million pills a day just to get by :)
The label also advises providers that simply discontinuing the drug may not remedy any psychiatric problems and that further evaluation may be necessary. “In some cases, stopping Accutane alone may not be enough to relieve the mood changes,” says Jonathan Wilkin, MD, director of CDER’s division of dermatologic and dental drug products. “Psychiatric treatment may also be needed.”
My first dermatologist didn’t want to put me on Accutane since I was at the “child-bearing” age. The second dermatologist, I found told me since nothing was working, Accutane would be the best choice for me and I would only be on it for 5-6 months and my acne should completely go away. They had me sign a waiver about using 2 forms of birth control at all times
Accutane (Isotretinion) – Warnings and Side Effects
Less common accutane side effects may include:
You may not be able to tolerate your contact lenses during and after your therapy with Accutane.
The registry for prescribers may involve a continuing education course that doctors would have to take to be able to prescribe Accutane. According to Hoffmann-La Roche, about 85 percent of Accutane prescriptions come from dermatologists and 15 percent come from primary care physicians. The course would be open to all medical doctors. And all Accutane patients would have to sign a mandatory consent form that would address both pregnancy and psychiatric issues, Beitz says.
Of the 500,000 women enrolled in the Slone survey from 1989 to 1998, there have been 958 pregnancies, 834 of which were terminations (either elective, spontaneous or due to ectopic pregnancies), 110 that resulted in live births, and 14 patients that had unknown outcomes. Of the 60 infants with available medical records, eight had congenital abnormalities. Since Accutane’s approval, Roche has received close to 2,000 reports of Accutane-exposed pregnancies, 70 percent of which occurred after the PPP began.
See “Why Acne Forms, and How Accutane Knocks It Out.”
Roche does not want to have any Accutane-exposed pregnancies, a company spokesperson says, and plans to continue educational efforts. This year Roche launched a targeted Pregnancy Prevention Program that focuses on women who are at highest risk of becoming pregnant while taking Accutane.
Risks of Buying Accutane (isotretinoin) over the Internet
– If you become pregnant, you must immediately stop taking Accutane and see your doctor;
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.
Monthly blood tests also allow doctors to monitor patients for other adverse effects. Elevated triglyceride levels, which can be associated with pancreatitis, have occurred in about 25 percent of patients in clinical trials for Accutane, and about 7 percent of patients showed an increase in cholesterol levels.
Some good things that have happened..I seemed to be losing weight, not as hungry..not sure if a side effect of Accutane or just that I’m happier with my appearance and want to lose the weight now. I’ve had guys whistling at me which hasn’t happened in a long time..maybe just because my face is almost cleared up.
You should NEVER buy Accutane (isotretinoin) or any of the generic versions of Accutane without first seeing your healthcare professional.
FDA has also proposed a mandatory registration of patients taking Accutane, prescribers, and pharmacists. “The main reason is to ensure that pregnancy testing is done before the drug is prescribed,” says Julie Beitz, MD, of FDA’s office of postmarketing drug risk assessment. The goal would be to have doctors document negative pregnancy tests and to have pharmacies dispense the drug only to women who have had negative pregnancy tests. The program to track Accutane patients is expected to be in place by summer 2001.
FDA Warning: Don’t Buy Accutane Over the Internet
and asked if I got pregnant would I have any problems with having an abortion (since accutane causes major birth defects in the fetus), I have no problems with abortion, one-I’m not ready to have a kid and two-I’ve already had 3 abortions in my lifetime. They told me I would have to get monthly blood tests including a pregancy test before I could get my monthly prescription for accutane. They told me the side affects of accutane…my dermatologist gave me all the details however I was still a little scared about accutane because I’ll I’d ever heard about it was bad things so when I got home – I started searching on the internet for other people’s experiences which actually made me feel better about taking accutane. For other journals/experiences, there are links at the end of my journal.
To learn more, visit FDA’s Accutane page on the Internet:
The American Academy of Dermatology and the Dermatologic Nurses Association were among those who testified at the September 2000 committee meeting in opposition to a mandatory registration, saying that it would be a disservice to patients, making it harder for them to obtain the drug. Others, including the March of Dimes and the Public Citizen’s Health Research Group, testified that they want to see stricter measures for Accutane.
Considered the biggest breakthrough in acne drug treatment over the last 20 years, Accutane is the only drug that has the potential to clear severe acne permanently after one course of treatment. (
According to FDA, exactly how well the PPP has worked is unclear. Experts say the PPP is a significant program that has prevented many pregnancies and is the first of its kind initiated by a pharmaceutical company. Roche has made extraordinary efforts to educate patients that they must not become pregnant while taking Accutane, says a Roche spokesperson.
Most patients in the Slone survey have reported that they understood Accutane may cause birth defects. And according to Roche, the percentage of female patients who reported they were pregnant when they began Accutane dropped from 30 percent of pregnancies reported in 1989 to 11 percent of pregnancies reported for the period of 1991 to 1997. But substantial noncompliance with the PPP continues to be reported.
You should not donate blood during your therapy with Accutane and for a month after you stop taking it.
Though the drug’s label previously listed depression as a possible reaction, FDA strengthened the label warning in 1998 after reviewing cases with serious outcomes reported in the years after the drug was approved. The new labeling states that Accutane may cause depression and psychosis, and that in rare cases it may cause suicidal ideation (thoughts of suicide), suicide attempts, and suicide.
Many patients say they feel better about themselves after receiving successful treatment for acne. Evelyn Germanakos, of Los Angeles, Calif., struggled with acne as an adult, and says she felt like her old self after Accutane cleared up lumpy blemishes in 1997. “I had gotten to the point where I didn’t even want to go outside or be with people, let alone look in the mirror,” she says. But while Accutane may help lift psychosocial distress such as embarrassment, evidence suggests that it may actually cause serious psychiatric disorders in some people.
FDA’s experts say it’s a balancing act. The value of Accutane is clear, but when it comes to even one report of death-whether it’s suicide, miscarriage, or some other cause-FDA must make choices that will best protect the public’s health.
I started Accutane on November 15, 2002 because I’ve had cystic acne since I was about 25, I am now 33. I never had it when I was a teenager and only got it when I was an adult. I tried everything from home remedies to TV products to antibotics and even birth control pills (which may be the reason I never had it til I stopped using birth control – birth control in general made me sick and depressed and screwed around with my hormones but that’s another story) – anyways, nothing worked. I was depressed because I was always trying to cover up the acne, makeup made it worse. I didn’t care if I lost weight or not because I had low self-esteem from the acne.
(60mg once a day and 40mg once a day) except that I seem to have broken out under my breasts, all over my back, my chest and deep acne nodules on my face and butt. I had some more physical problems and no one knows if its related to Accutane or not but I can honestly say that I’ve never had this problem before and haven’t had as many physical problems before Accutane. My feet went numb about mid-April and my doctor can’t figure out what is wrong..I’m hoping that once I’m off Accutane it goes away. My family doctor have me go for an Xray of my back and an MRI – nothing showed up. I understand that Accutane screws another with your immune system..so who knows what is causing the numbness, the dermatologist says that accutane wouldn’t cause it but why does she keep asking my about back pain every checkup? My joints in general ache – definetly a known side effect of Accutane. The good news is that for a least the last half of April, I was able to wear makeup to cover what little acne I had on my face..at few days, I stopped wearing it just to clear up the nodule that erupted but all in all, I don’t need that much makeup anymore to cover the acne and most of it on my face is starting to clear up.
Update/Disclaimer 3-2-08 ** I’m not a doctor, this is my experience with Accutane. Alot of people lately have been asking me if its safe to use accutane or what are their side effects going to be or if I’d recommend Accutane. I’m not a doctor and I can only tell you what my side effects were and how it changed my life. I think you should read as much as possible about Accutane – the good and the bad and make a decision that is good for you, only your heart & soul can tell you what to do. I read alot of other journals before I decided to do it and I couldn’t be happier. 6 years later and I’m still 99.9% acne free, I do occasionally get a pimple now and then but nothing like it was when I first started this journey
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.
Its only a couple of days into the week but finally all infections seems to be clearing up and I’ve only had a few little white heads on my stomach of all places and on my butt. I still have back pain but I see the doctor in a couple of days for my checkup. The only thing that is a problem now is (1) my skin is so dry that any fabric that is tight or harsh like wool hurts (2) I could use lotion every minute of the day and I wouldn’t know I had any on (3) I am so dry that astroglide has become my friend otherwise I have dry itchy skin in a place I don’t particulary want to be dry..now my doctor said this would happen (but honestly – a healthy 30 something shouldn’t be dry ever) and (4) my nails are so brittle they break opening my jacket – I finally broke down and cut my nails off (and this was the first time ever I had grown them out and liked it)....anyways..will check back in after my appt. I’m hoping that I only have a month left on accutane..I really want to go on vacation and see Todd but not with an acne outbreak..I want my face to be clear and free of acne.
When you first start taking Accutane, it is possible that your acne will get worse before it starts to get better.
“Sometimes people tend to dismiss the impact of acne because it’s not life-threatening, says Kathy O’Connell, MD, PhD, a medical reviewer for Accutane in FDA’s division of dermatologic and dental drug products, Center for Drug Evaluation and Research (CDER). “But patients with severe acne know all too well the very real suffering caused by this disfiguring disease.”
Because it is a high-risk drug, Accutane should be reserved for cases of “severe recalcitrant nodular acne,” according to the product’s labeling. This type of acne is resistant to standard acne treatment, including oral antibiotics, and is characterized by many nodules or cysts—inflammatory lesions filled with pus and lodged deep within the skin. These lesions can cause pain, permanent scarring, and negative psychological effects.
– If you take Accutane, you must use effective birth control from 1 month before the start of treatment through 1 month after the end of treatment;
To learn more about FDA’s program to warn consumers against buying accutane and its generic versions online, please see:
How does Accutane work...
My Accutane Experience
Isotretinoin (marketed as Accutane) Capsule Information
Accutane Side Effects
other Accutane Journals
Website: choiceisforce.com/pharmacy/accutane/
User since July 29, 2008