Pimozide (ORAP) is carcinogenic ???!!!

[chagit_b]

Hello to all!
Long time that I haven't been able to surf the forums, good to see that they're on again!

My 7.5 Y/O son (Tourette's + ADHD+ rage attacks and mild OCD) is treated with PIMOZIDE 3 mg per day. It is quite helping with the tics, though not an absolute beneficial, but then, I haven't met the drug that does that and I am on this journey for the past 6 years with my two sons...
I got worried after reading that there was evidence found in animals (not human) that pimozide is carcinogenic in humans!

http://en.wikipedia.org/wiki/Orap

I also read this fully:
http://www.gatepharma.com/ORAP/orapscriptinfo.pdf

And now I am worried if it is wise to continue with this med???
(Risperdal had been given in the past, but stopped helping after 2 years even when doses were elevated, and had side effects of weight gain also Clonidine aggravated his rage attacks and made him fall asleep in mid day when doses elevated)

I am looking for advice and based data on this subject- Is Pimozide (ORAP) carcinogenic???

Tnx!

[Lara]

It's good to see you again.
I actually delayed posting to your questions because it's pretty complex issue and there isn't too much information I could add to what you would have already read. My son took Orap/Pimozide for a few months many years ago, btw. Most of the information regarding Orap/pimozide and carcinogenic studies appears to involve mice and rats treated at very high doses as you've probably noticed. There has been information released about other medications which are sometimes used to treat tics, including Risperdal/Risperidone and the potential to increase risk of pituitary tumors. The inserts for Orap/pimozide DO mention contraindication for people with breast cancer. I would recommend that if you're searching for more information then check into _pimozide and prolactin_ and/or _pimozide and pituitary tumors_. There is little out there that I can find for research in humans though and particularly in children. Also, the site listed below from mentalhealth.com has always had good research section in their medications lists.

http://www.mentalhealth.com/drug/p30-o01.html
As with other neuroleptics, endocrine effects and ECG changes have also been reported with pimozide.

This one below is regarding atypical antipsychotics including Risperidone, Olanzapine, Haloperidol, Ziprasidone, Clozapine, Quetiapine, and Aripiprazole. The pharmacology of Pimozide, although an antipsychotic, is somewhat different.

http://www.medscape.com/viewarticle/533771?src=mp
Antipsychotic Drugs Linked to Pituitary Tumors

June 3, 2006 – Treatment with potent D2-receptor antagonists such as risperidone (Risperdal, Janssen-Ortho) may be associated with pituitary tumors, researchers say. In the June 2006 issue of Pharmacotherapy, the team notes that while they haven't uncovered a causal relationship between the drugs and tumors, clinicians and patients should be aware of this important adverse effect.

Rats and mice - again note dose. It's in the section called Carcinogenesis, Mutagenesis, Impairment of Fertitity.

Carcinogenicity studies were conducted in mice and rats. In mice, pimozide causes a dose-related increase in pituitary and mammary tumors.

When mice were treated for up to 18 months with pimozide, pituitary gland changes developed in females only. These changes were characterized as hyperplasia at doses approximating the human dose and adenoma at doses about fifteen times the maximum recommended human dose on a mg per kg basis. The mechanism for the induction of pituitary tumors in mice is not known.

Mammary gland tumors in female mice were also increased, but these tumors are expected in rodents treated with antipsychotic drugs which elevate prolactin levels. Chronic administration of an antipsychotic also causes elevated prolactin levels in humans. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with antipsychotic drugs, the clinical significance of elevated serum prolactin levels is unknown for most patients. Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of these drugs and mammary tumorigenesis. The available evidence, however, is considered too limited to be conclusive at this time.

In a 24-month carcinogenicity study in rats, animals received up to 50 times the maximum recommended human dose. No increased incidence of overall tumors or tumors at any site was observed in either sex. Because of the limited number of animals surviving this study, the meaning of these results is unclear. http://www.rxlist.com/cgi/generic3/orap_wcp.htm

ORAP may have a tumorigenic potential. Based on studies conducted in mice, it is known that pimozide can produce a dose-related increase in pituitary tumors. The full significance of this finding is not known, but should be taken into consideration in the physician's and patient's decisions to use this drug product. This finding should be given special consideration when the patient is young and chronic use of pimozide is anticipated (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility).
http://66.102.7.104/search?q=cache:DvFY1Ue4uSAJ:www.rxlist.com/cgi/generic3/orap_wcp.htm+Pimozide+and+tumors&hl=en&gl=au&ct=clnk&cd=3&client=firefox-a

Pediatric Use
Although Tourette's Disorder most often has its onset between the ages of 2 and 15 years, information on the use and efficacy of ORAP in patients less than 12 years of age is limited.
http://www.rxlist.com/cgi/generic3/orap_wcp.htm#P

[Ingwaz]

I usually don't post in forums besides the artistic expression...it makes me sad that so many people are scared/against medication. Personally, my TS is severe without meds, and I don't mean the natural way, which I was told wouldn't help me. so I feel bad when I come here, like I'm dirty or something :(

I um, did want to say tho...that I have been on Orap for maybe 11 years. They kept sure my heart was okay by monitoring it with all these wires (EEG? or EKG? always confuse those...) when I was little and I seemed to handle it well, though that's just me, everyone else isn't like me, so..lol..:o

But..Orap was and is a maricle drug for me. Before Orap? I'd have over 150-200 tics in just a minute or so. Like I said, I have severe TS; but after all these years, I am now a mild/moderate ticcer and I have found it really helped me!

That's the other reason I don't come here tho. I'm not good with knowing what drugs do, and side-affects other people may have that I don't. I actually dunno if my Orap is for my tics or for my spazms/muscles, but I do know I'm sure glad I have it, because I feel more free in my body having less tics!

so..um...I'm gunna go now. I don't want to make people mad--I know many don't like meds/like the natural way, and now I feel dirty again. :(

Ingi.

[Lara]

Hi Ing (((Ing))),
I'm not sure what exactly made you feel "dirty" but it makes me really sad to report information and have you say that. Nothing in my post or in chagit's was posted to make anyone feel that way at all. Frankly I just don't understand. chagit is trying to do the right thing for her children and she'd obviously come across information that was frightening and was asking for references to help clear that up. Everything I posted was just information. There was absolutely nothing personal in it at all, just information. chagit and I have both given medications to our children. I'm stunned by your reaction at the reporting of valid references mainly about mice. :confused: I've just about thrown in the towel here myself actually. If my post was enough to upset you that much, then I don't know what the heck I'm doing here anymore.

[Ingwaz]

Lara Booga, I've written you a PM and I feel really terribly. I wasn't directing this at you, or chagit, but I've seen over the years and it isn't everyone, but select groups who have been anti-drug and now I see how stupid I was to post here at all.

Why did I even post this? It was me venting years of frustration over doctors, people, and fellow TSers, and even a friend who isn't disabled, telling me to go natural, but my neuro told me it just wouldn't work for me because of the severity of my Tourettes.

It is true, I have been on Orap for 11 years, and I dunno if they knew about this concern or not, and it is frightening. I wanted it to be known that I was okay on it though. I dunno why. It's really been a maricle drug for me. I used to have so many tics, then Orap, then bang! No more tics. so I wanted to let everyone know that maybe it was just certain people who are more sensitive. I guess I really am stupid.

I'm just gonna stick posting in the artistic forums now. Now I know why I don't post in medicale ones, it's because I'm not medsavvy. Lara, It was not you I was calling anti-med, you are so knowlegable in everything med and and..brain wise! You know exactly how brains work and how a certain something will react with it. at least that's how I see it.

I'm really really sorry. Can you forgive a very silly, a very stupid friend?

[chagit_b]

Though Lara spoke for me better the myself, I did got the feeling behind your post, and knew that it came from that bitter place, this is why I am okay with your reaction, after all, my son also is tic free due to the Orap, and though I learn and quote the risks, I still medicate him - and it does stop the tics at most , so we are in the same boat you and I (and all TSers).
Tnx anyway for replying!

[Lara]

Ingwaz, It's OK. I understand.
I just thought your post was directed at me and had me totally bamboozled.
I figured you'd known me all these years and I couldn't understand why you would be saying that to me or chagit. My mistake.

My son was doing well on Orap for a few months, but then he started experiencing extreme separation issues and anxiety and absolute school refusal, so it was ceased. Orap is a complex medication and certainly doesn't suit everyone and there are precautions that need to be adhered to when taking it. Once the strange symptoms started for my son, the doctor and I decided that those symptoms were outweighing the positives, and that's what it's all about sometimes. He was actually switched onto Risperdal at the time, which had just become available here where I live. That's a whole other story though and seems so long ago now.

Ing, I wish you would post here more. We need young people like you who have so much experience. I've known you a very long time and know how difficult life has been for you on and off. I truly do understand where you're coming from about the frustration with attitudes. It's reminds me of that old saying about walking in another persons shoes. Sometimes I'm reminded at how fortunate I've been both here in my own family to see such a wide variety of symptoms and severity and also in my travels overseas to meet so many people from the TS community. It opened my eyes and my mind so much. Some people really do it very tough and my heart has always been with them.

(((Ing))) You're a wonderful young person and I'm blessed to know you. I do wish you would post more though ;)

[Ingwaz]

Lara, I got your PM and replied to it. I'm really really really releived and happy that you understand I didn't mean the post to be towards you....You're so smart with the medical terms and the brain and medication, I really admire you helping people!

Cagit, I am so so sorry for ruining this thread. I posted this here basically out of frustration, because I see people posting (moreso in the past, but still sometimes now,) about how "this medication was horrible! don't use!" but then they don't say why. Or someone--which has happened to me, when bt2 was first made some years ago--talks about medication, people barge in and say it's wrong, you should only take natural medication. It made me feel so bad, like I was doing something wrong.

Chagit, I feel very poorly upon myself for posting a vent on anyone. I really hope you can find the right medications that work for you and/or your children. It took me so many years before I found my right dose, and it was hard and scary! so I'm here for you while you find your own "maricle prescription" whatever it is. I'm not anti-anything, it's just personally one works better for me. If you can use medical drugs, or medical the natural way, whatever works for you and/or your children is what matters. It's hard being a Touretter, and scary, too, so I just want my friends to be okay. I worry too much!!

I am glad Lara understands and I hope you do as well that it was not directed at either of you, my vent, and I love both you dearly as your part of this forum and this place is my family. It's just really hard for me when people are ignorant because all my life ignorant people have been harmful one way or another. But I am here for you! I may not know anything much medical wise, but maybe I can post here just for support. No more vents! and I en't talking about meds no more. I must be more positive!

and speaking of positive...we got a fake christmas tree last year, and just assembled it. I have a sister in a wheelchair who never used to be able to help decorate the trees but this one is made just in the right way and is small enough and short enough that she can help decorate this year. I can't wait till she gets home from her hair appoiment! we're tree trimmin, woohoo!