FDA Launches Accutane Registry

FDA Launches Accutane Registry

There are 70 comments on the Pharma-lexicon.com story from Mar 5, 2006, titled FDA Launches Accutane Registry. In it, Pharma-lexicon.com reports that:

Beginning Tuesday, patients taking Roche 's acne drug Accutane now are required to register with an online FDA tracking database, called iPledge, in order to receive their prescriptions, the Denver Post reports ...

Join the discussion below, or Read more at Pharma-lexicon.com.

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Linda Artrip

United States

#1 Mar 10, 2006
I'm vey upset. My son is in the middle of his treatment plan and I am unable to refill his prescription. His doctor and office staff is unable to connect to the ipledgeprogram web site to register the patients. They have also called several times and get disconnected.

What are we supposed to do now?
John Marshall

AOL

#2 Mar 11, 2006
Clearly the subcontractor, Covance, completely miscalculated the demand that would be required during this first week of the program. While the FDA seems aware of the problem and patient frustration - no contingency has been mapped out. No corrections have been made.

Consider the number of existing patients that would need to register this first week.

I was unable to register my daughter within the seven day window. I have spent hours on the phone both day and night. The voice mail system advises you to call back later and hangs up.

Finally, I was inspired to use the "report a pregnancy"/option #3 on the phone menu. I was then transferred to the password team. For me, too little too late. Good Luck!
John Marshall

AOL

#3 Mar 11, 2006
Additonally, I have heard through chat that some are considering the internet option for "filling the void" in their treatment while the IPledge program implementation is sorted out.

This will not be my recourse. IPledge is creating some additional risk for some. I would be concerned about generics manufactured outside the country. Good intentions gone bad.
John Marshall

West Springfield, MA

#4 Mar 16, 2006
I just got a notification on my desk regarding the ipledge program. It was a letter addressed to manufacturers with interesting information. They are requesting that patients and parents offer their experiences to [email protected] or fax to 202-842-4355. Patients must include their name, address, and phone number in the statement and give the Academy permission to share it with the public. The Academy will forward patients' stories to their legislators.
I knew you would be interested in this and I am informing everyone that has been troubled about this.
Good luck
Paula

AOL

#5 Mar 21, 2006
I understand why iPledge is in affect. However I hate it with a passion. After much resistance from me to take accutane (due to side effects) I finally decided I would do it. I have one more day before my 7 day window expires and I can't get through to the damn system. It is a $#%@^* joke! I am so angry that I have to go through all of this to take a test about birth control. If this drug is so dangerous in more ways than one, it should be made illegal. PLUS Im supposed to pay for the doctor visit that in the end if I dont get through tommorow for my password will be for nothing. My money will be wasted because the government can't get it together. What a waste of energy and time.
KRISTY

United States

#6 Mar 24, 2006
I work in a dermatologist office as a medical assistant. Since the I Pledge program came in effect, i have been doing nothing but trying to figure out how to get female patient's approved and able to fill there scripts. Is all of this really necessary?
leticia

Somis, CA

#7 Mar 30, 2006
very upset with this ipledge program my son is on his 5 month and has had problems registering with ipledge his doctor says she's done everything she could and ipledge will not let him get a rx till 23 days what are these kids suppose to do! what if break outs accure do they not realize how devistating this is for the patients and families that have to see them go thru this
Dr Ann Blake Tracy

AOL

#8 Mar 31, 2006
You are worried about "break outs"????!!!! You have had your son on a drug that could cause him to committ suicide at any minute and you are worried about pimples on his face? Can you tell me where the logic is in that? There are all kinds of harmless natural things one can use for acne. Why take such a risk with such a deadly drug as Accutane? Now I know where the phrase "Get a clue!" came from!

Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
leticia wrote:
very upset with this ipledge program my son is on his 5 month and has had problems registering with ipledge his doctor says she's done everything she could and ipledge will not let him get a rx till 23 days what are these kids suppose to do! what if break outs accure do they not realize how devistating this is for the patients and families that have to see them go thru this
Tim

Alameda, CA

#9 Apr 3, 2006
Itís not just about a pimple or two, as Iím sure is true for most who use Accutane. My 13 year old sonís acne is so severe on his upper back and shoulders that it is too physically painful for him to wear a backpack; this morning, he was in tears because of the pain of just trying to put on a shirt. We have tried many other, less risky treatments Ė including harmless, natural things -- but to no avail. We decided to use Accutane, as a last resort.

I see that you have a Ph.D. in psychology; do you have the actual number of suicides caused by accutane? Or the actual numbers of suicides linked to accutane? From what I can find, there has been 240 suicides reported that have been linked to (but not necessarily caused by) accutane world-wide since 1982, compared to over 12 million users of accutane world-wide. If you have different statistics, please share them.
Dr Ann Blake Tracy wrote:
You are worried about "break outs"????!!!! You have had your son on a drug that could cause him to committ suicide at any minute and you are worried about pimples on his face? Can you tell me where the logic is in that? There are all kinds of harmless natural things one can use for acne. Why take such a risk with such a deadly drug as Accutane? Now I know where the phrase "Get a clue!" came from!

Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org

<quoted text>
Ruth

North Haven, CT

#10 Apr 10, 2006
The IPledge program is a horrible bureacracy with no means for special circumstances. I am a woman going through menopause who's husband has had a vasectomy almost 30 years ago. I was told I could get pregnant by someone else and I must go on birth controls pills. I guess the FDA doesn't care that it is dangerous for a 50 year old woman to be on the pill. As long as they don't have a baby with birth defects. I am in the middle of my treatment and will have to wait 2 months before my Rx can be filled because I missed the fast track by one day. FDA, get some special circumstance programs in place!!!
Linda from Columbia MD

Dayton, MD

#11 Apr 19, 2006
I am a mother of a 20-year old son who was prescribed Accutane in another country (in Jan. 2006) because the doctors here would rather wait for the kid to almost commit suicide due to his acne! Well... you can't even imagine what we have been through trying to get this prescription renewed since the FDA's IPledge came into effect in March. Every time he goes to refill his prescription they tell him he is not registered and HE IS! Then they lost his IPledge card. Can't get another card because the toll free nbr. that IPledge has on their website is useless - can't even get a voice on the phone. Then his prescription runs out... then he starts all over again .... needs to visit the doctor (more money wasted).... gets another prescription.... take it to the pharmacy but has to wait now because a certain period of time has to still pass.... gets to the pharmacy to hear the same old story being repeated..... YOU ARE NOT REGISTERED!!!! He has an IPLedge nbr. The doctor has confirmed he is registered so WHAT IS THE PROBLEM? He was supposed to be on this drug continuously for at least 3 to 4 months continuously but has had two gaps inbetween. This one has been for well over a month. If someone is willing to take the initiative I will certainly help them start the procedures for a lawsuit as my son is now getting scarred due to his breakouts which are being cause by his pause in treatment.
Angie Thorne

AOL

#12 Apr 26, 2006
I too had a difficult time with the IPledge program when I first started Accutane... I have only been on Accutane for two weeks. All the testing & protocol you have to go through (especially for women) is extreme... but there are definite reasons for it. From my experience the automated IPledge hotline is useless... just a big circle you run through & get no answers! If you need answers, call the hotline & press the key that says "You want to report a pregnancy." Even it is not the truth... I have found that is the ONLY way you will be able to speak to a customer service rep. that can help you. Once you get a person on the other end, just immediately explain that you are NOT really reporting a pregnancy... but that you were desperate for help & this is the only way you could get it... Actually... one of the nurse's in my dermatologist's office is who recommended doing that... because she has had difficulty with the IPledge system too... Just a suggestion... Best of luck... Keeping my fingers crossed as I will be renewing my prescription in a couple weeks!:)
Stephanie May

Lafayette, CA

#13 Apr 27, 2006
I am researching a story for a women's glossy on Accutane. I'm seeing the ambiguity of opinions on the drug in this thread. On the one hand, it works, on the other hand, the side effects are scary. I'm looking for women in particular with compelling stories of their personal experiences on Accutane. Do you have one or know of one? Contact me at [email protected]

I work for freelancer Loolwa Khazzoom. See samples of where she's published here: http://www.loolwa.com/articles/
Brian Costlow

Columbus, OH

#14 May 2, 2006
I am a 41 year old man. I am being treated for an adult recurrance of severe acne, in which the nodules regulaly mutate to large cysts that rupture and in some cases get secondarily infected. Isotretinoin is my shot at not having to take tetracycline (which only moderates the problem somewhat anyway -- and I'm one of those people who get digestive irritation with tetracycline) the rest of my life.

The first month, which was a month before iPledge was mandatory, was fine.

The second month, I couldn't get my prescription. It turned out part of the system that should have been active only for women was also flagging men, and my doctor's office had to go into the system and mark me as 'not pregnant' in order for the scrip to go through.

The third month, I got the scrip, but had to head out of town that day for work, and I forgot to drop it off at the pharmacy before I left. When I got back, I was one day past the seven day window. I called the doc, who just tried to write a new one, but that's getting flagged because it's not been 30 days since the one that they won't fill.

Should I have remembered to drop it off? Yeah. Should I not be able to get FDA-approved drugs, prescribed by a physician, because of that? No. Am I going to get pregnant? If I do, I'd guess it's enough of a miracle that birth defects are the least of my worries.

You know the FDA and pharmacuetical firms involved did this over fears of large lawsuits. I'm wondering what happens if we institute a class-action against Covance, the FDA and the manufacturers for interfering with the doctor-patient relationship?

Interested? My first initial and last name at gmail. No, I'm not a lawyer, but if you know--or are--a good class action attorney, email me.
Angie Thorne

AOL

#15 May 3, 2006
Dear Dr. Tracy:

Have you ever suffered from severe, recalcitrant cystic acne? The kind that leaves hard, painful nodules under your skin, that take sometimes months for one to just clear up, & usually leave behind a deeply pitted or red scar as a reminder... If you have not "walked in our shoes", then you do not know how traumatizing it is... mentally, emotionally, physically & socially. Therefore, you most likely will not understand the depths a person will go to in hope of a cure for their cystic acne.

I am a 35 year-old mother of 3 young children... who has suffered with cystic acne since age 17. I am an active, healthy & intelligent woman... but also one who is desperate to find a cure for my cystic acne. I have been on Accutane for three weeks & had many reservations about going on it. It took me several months to finally take the step & many years of suffering to seek Accutane as the cure.

I have tried every over-the-counter medication, prescribed topical & oral medications, natural herbal supplements, vitamins, injections, & laser treatments... & what has helped me... NOTHING. And I am still suffering from cystic acne 18 years later & have a face full of scars to look at in the mirror everyday to remind me of my losing battle with acne.

Let's be REAL, Dr. Tracy... Do you think that any Accutane users want to be on this medication? Of course, the answer is NO... given all the potential severe side effects that are known, as well as the fear of the unknown. Do you not think we would prefer a safer way to rid of ourselves of cystic acne?

As far as depression goes, who isn't suffering from depression if you have cystic acne (when you have all these sore & unpleasant looking cysts & scars covering your face)? This skin disease effects you not only physically, but mentally, emotionally & socially as well. To place the blame SOLELY on Accutane is an unfair accusation.

"Get a Clue" was your closing line to this desperate mother & her son... Is that the best advice you can offer, Dr. Tracy? I found that to be the most offensive, outrageous & insensitive response that anyone could have given... & was completely taken back that it was given by a doctor.
Dr Ann Blake Tracy wrote:
You are worried about "break outs"????!!!! You have had your son on a drug that could cause him to committ suicide at any minute and you are worried about pimples on his face? Can you tell me where the logic is in that? There are all kinds of harmless natural things one can use for acne. Why take such a risk with such a deadly drug as Accutane? Now I know where the phrase "Get a clue!" came from!
Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
<quoted text>
pinkdivinity

Wood River, IL

#16 May 3, 2006
Tim wrote:
Itís not just about a pimple or two, as Iím sure is true for most who use Accutane. My 13 year old sonís acne is so severe on his upper back and shoulders that it is too physically painful for him to wear a backpack; this morning, he was in tears because of the pain of just trying to put on a shirt. We have tried many other, less risky treatments Ė including harmless, natural things -- but to no avail. We decided to use Accutane, as a last resort.
I see that you have a Ph.D. in psychology; do you have the actual number of suicides caused by accutane? Or the actual numbers of suicides linked to accutane? From what I can find, there has been 240 suicides reported that have been linked to (but not necessarily caused by) accutane world-wide since 1982, compared to over 12 million users of accutane world-wide. If you have different statistics, please share them.
<quoted text>


Contact US Representative Bart Stupak (D - First District - Michigan; his son suicided with no symptoms of depression. Only a prescription for accutane. Don't let anguish and desperation influence you to make non-critical choices.
Lexy

Amesbury, MA

#17 May 12, 2006
I am 13 years old and after almost eight months of accutane my face was almost clear and was starting to become the person I always wanted to be and now my percription has been cancled and my acne is starting to worsen. As a teenager it is extreamly hard to go to school everyday and know that any amount of cover up will not help you now, and know that everyone is staring at your face or hidious skin.Please help get our percriptions filled again because only some patients have become pregnant and the other ones have to suffer as a result of their actions and that to me is unfair and cruel.
in the know

AOL

#18 Jun 16, 2006
Tracy's group is a front organization for scientology. don't be fooled, folks. the scientologists are against ALL drugs, and they also don't believe that depression is real or that psychotropic drugs are anything but evil. this registry is also a result of pro-lifers in the FDA.
linda

Waunakee, WI

#19 Jun 23, 2006
I am 36 yrs old, My doctor suggested I take accutane for oily skin.(Big mistake), Side effects<...Facial hairs, hair growth all over my body, long periods,Blood Clots, lost 40pds. depression, hair follicules on my face, Turn a shade darker. Discontinued after 7weeks, It was a bad experience for me. My 2nd. Derm. said, I should have not been on the med. for oily skin in the first place. Because I listend to my Derm. my face is ruined, My beautiful glowing skin is ruined. Please get the facts, Don't take the word of every doctor.
Ian

AOL

#20 Jun 25, 2006
Tim wrote:
Itís not just about a pimple or two, as Iím sure is true for most who use Accutane. My 13 year old sonís acne is so severe on his upper back and shoulders that it is too physically painful for him to wear a backpack; this morning, he was in tears because of the pain of just trying to put on a shirt. We have tried many other, less risky treatments Ė including harmless, natural things -- but to no avail. We decided to use Accutane, as a last resort.
I see that you have a Ph.D. in psychology; do you have the actual number of suicides caused by accutane? Or the actual numbers of suicides linked to accutane? From what I can find, there has been 240 suicides reported that have been linked to (but not necessarily caused by) accutane world-wide since 1982, compared to over 12 million users of accutane world-wide. If you have different statistics, please share them.
<quoted text>
when i sleep the pain of the cysts wakes me up...i totally understand your sons feelings...this disease really sux

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