Consumer advocacy group Public Citizen told a U.S. Food and Drug Administration advisory committee to withdraw the acne drug Accutane from the market. Accutane has been linked to causing birth defects.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the drug causes birth defects as malformations of the heart and brain, and can cause depression and create pressure in the brain in patients taking it.
“About 25 percent of the babies born to mothers taking the drug have serious birth defects and 50 percent are mentally disabled. Many women who become pregnant while taking the drug have abortions because of this high birth defect rate,” Wolfe said.
Accutane is approved only to treat severe cystic acne but is prescribed to many people who have mild acne. Dr. Wolfe estimates that Accutane is prescribed 26 times more to women than it should be.
Public Citizen claims officials have known for at least 20 years of the dangers associated with the acne drug.
(via Public Citizen)
13 responses so far ↓
Debbie Banner // Mar 3, 2004 at 1:35 pm
I am in complete agreement with Dr. Wolfe and the Public Citizen’s Health Research group. I pray that Accutane will be taken off the market and only used under the tightest regulations. The mandatory registry will not prevent more birth defects and probably won’t even help give an accurate number of the actual pregnancies. Some girls will become pregnant and out of pure shock and panic, they will not even return to the dermatologist and report it. Thank you to Dr. Wolfe for voicing his views.
Renata // Apr 20, 2004 at 5:23 pm
Accutane should not be taken off the market. It is very effective and provides relief to people with severe cystic acne. I do believe if the drug is prescribe to young adults, specific steps should be taken to address pregnancy and mood changes.
I am a 40 year old women with cystic acne and I feel the current regulations for women my age are ridiculous. I am an adult, not a child and I resent being forced to take birth control pills inorder to get a prescription for accutane.
anna // Oct 27, 2004 at 4:58 am
I feel that the responsibility lies ultimately with the patient who has agreed to abide by the guidelines set up. Compliance is a key issue. I had one round of accutane in my late 30’s and it helped tremendously. 3 yrs later I am going on another round. I had tried everything for over 25 years to take care of my cystic acne. If this drug is removed from the market, those who really need it will be the losers and it will be probably because there are those who want the benefits without the work. The doctor can do so much but we as patients need to take the responsiblities of taking ANY medication seriously. Should we look at strict restrictions on tylenol or removal of it from the market (it can cause problems with the liver) just because some people do not follow FDA and manufacturer guidelines. of course, not . Responsibility and accountability .
mary pryjda // Nov 23, 2004 at 7:18 pm
it is extreamly paining to think that a drug such as accutane, which works miracles not only on the appearance, but as well as self-confidence, might be taken off the market. For people who chose to be put on the drug, a psychological evaluation should be inforced. Because of few ignorant and irresponsible women, people like my friend, who suffers from cystic acne on her face, cannot be put on the drug. Also, because of the scare, doctors refuse to put mature and responsible women on the drug../..causing them to continue on with their suffering and humiliation.
krista Savino // Nov 24, 2004 at 7:03 am
I am a 21 year old women who has suffered from cystic acne since i was 11. I have tried everything, and i do mean everything to fix the problem. i am a wreck when i have the breakouts, and i am so sensitive to topical products that they usually leave me with scabs on my face. to someone who is already very self-concious this is the social equivalent of suicide. i am currently waiting to see a derm (i just moved to nj from wa state) who accepts straight medicare, because that is all i have right now. the breakouts send me into a depression where i do not leave the house, and, since i have been off of it for more than a month i am too depressed to work. accutane. gave me a new lease on life. i will do anyhting i can to make sure that this drug is made available to the public. please email me with any and all information.
Ange // Nov 24, 2004 at 11:59 am
It is so ridiculous how some adults can blame a drug that does miracles for the skin. They are grown enough to know the side effects that the drug can cause, and if they didn’t like the side effects they shouldn’t take it. I knew what the side effects were and if I had to do it all over again I would still take it. When I was taking the drug my doctor required that I’d be tested every month for my liver and pregnancy even though I had my tubes cut. I don’t see what the excuse is for some patients, they know what they are doing, they are just irresponsible.
KayCee // Dec 1, 2004 at 8:35 am
I am a 17 year old woman and I started taking accutane just after my 16th birthday because I’ve had terrible acne since age 9. I hope Accutane is taken off the market because it made me miss an entire month of school because of problems it caused in my brain that I have yet to fully recover from. There’s more reasons to take the drug off of the market besides birth defects, which are seemingly ignored.
S.Y. // Dec 21, 2004 at 4:21 am
I don’t believe accutane should be removed from the market. Most of the negative aspects of accutane stem from the irresponsibility of patients and doctors. Patient screening should be more thorough to prevent the agitation of any pre-existing physical or mental health problems. I also believe there should be an extensive progression study on past patients. Individual patients of the drug should endure the reprocussions of ignoring warnings and not caring for themselves properly, rather than punishing potential candidates for the drug by its removal.
sandy // Jan 7, 2005 at 7:35 am
Accutane should be removed from the market.
A very close family son who is a straight A student in high school, very active in sports, a stable young man.
His Parents had to take him out of school,they can’t leave alone for a second. This is a very sad story, what bright kid he was.
Ron // May 7, 2005 at 11:23 pm
I hope accutane is not taken off the market. I am a 15 year old male, and I have terrible acne on my back and chest. This acne has been an embarrassment to me and has prevented me from participating in any activities involving taking off my shirt. I also have embarrassing acne on my neck and redness on my cheeks and nose with blackheads and pimples. I am hoping to be put on accutane soon, and I pray to God I won’t have to go through the summer with acne. I know several friends who have been put on accutane, and have suffered none of the side effects, but have been completely cleared. Save Accutane!
Anita Vargas // Jun 26, 2005 at 4:48 am
I personally think this is a miracle drug, and that it would be very sad for the people that can benefit from this drug to lose it. There is nothing else for acne that truly works — speaking from a 20 year topical treatment use and antiobiotic use (along w/birth control use) perspective. I understand the concern with pregnancy, but unfortunately banning a drug from all of us because of a few stupid, irresponsible people just doesn’t seem like a reasonable solution. How about requiring a depo-provera shot with the accutane prescription? It lasts 3 months, and is 97-99% effective.
Lauren // Sep 5, 2005 at 8:32 pm
I totally agree that accutane should be taken off the market. I took it for only 4 months, my doctor prescribed it although I only had mild acne. I have suffered the consequences ever since. I went from 20/20 vision to 20/25, including cysts on my eyes during use, and shortly after completion of use i developed hypertension. take it off the market!
Neill // Sep 15, 2005 at 8:00 am
I don’t know what the fuss is, it didn’t work on me anyway so I couldn’t give a rats ass
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