Desperately seeking a dicontinued medicine can you help?

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A freind of mine has been taking Cylert (Aka Pemoline) and it is no longer being manufactured but there may be supplies in very small amounts in some pharmacies dotting the countryside. Evidently this is the only med that has helped him and even the former manufacturers no longer have a supply.

Him and a bunch of friends (like me) have literally been calling everywhere to find all stock still sitting on pharm shelves as soon it will be past the sell date and gone forever. There have been minor success, about 1 in a hundred places called have small supplies left. All of Walgreens is out.

His doc is willing to write scripts of any size to get whatever is left and he would even be willing to fly to another country to get this if needed but many discontinued it much sooner than the US. Yes, they know the dangers but this is the only med that works for his narcolepsy. He has talked to previous manufacturers all over the world and then some.

Anyhow, would anyone be willing to check with their local pharms and hospitals for this med to help this man out?

Thanks everyone!

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Cylert has had its FDA approval withdrawn, due to th erisk of severe hepatotoxicity. I know exactly how it feels when you find that one med that really works for you. However, IT may be safer for him to try a diffferent prescription.

Good luck.

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cylert has had its fda approval withdrawn, due to th erisk of severe hepatotoxicity. i know exactly how it feels when you find that one med that really works for you. however, it may be safer for him to try a diffferent prescription.

good luck.

this is untrue and incorrect. its patent ran out and because of lagging sales was discontinued, people were buying other cheaper meds that are avail now. they stopped making it a couple years ago and it is still for sale until supplies run out. it was once widely used for add.

he (and his doc) are very well aware of the hepatic effects being reported and each has figured it is much safer than the narcolepsy that he suffers from, and this is his only relief. he has tried several other treatments with no relief. evidently the risks are with children not adults (also used to treat add). i am certain her appreciates your concern but there is nothing else out there for him.

in fact, the fda is considering it as a compassionate investigational new drug (ind) -- specifically because there is no other medication like it. they (the fda) contacted him about getting a manufacturer to make it but we all know that this could take quite a long time.

the guy is willing to travel around the world to get this stuff (if it were avail!), can't anyone try to call a few local pharms and see if they have a stock?

pretty please?? this could mean a huge difference in the quality of this man's life.

if every member checked at the hospitals and clinics they work at and called ten hospitals, maybe, just maybe this guy can live a few more months symptom free.

in the meantime, pray fda comes thru for him.

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Specializes in Emergency & Trauma/Adult ICU.
This is untrue and incorrect. Its patent ran out and because of lagging sales was discontinued, people were buying other cheaper meds that are avail now.

I'm sorry but your post is untrue and incorrect.

http://www.fda.gov/cder/drug/InfoSheets/HCP/pemolineHCP.htm

" ... FDA ALERT [10/2005]: Liver Injury Risk and Market Withdrawal

The Agency has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product (Pemoline tablets and chewable tablets). ..."

I urge your friend and his MD to aggressively pursue alternate therapies.

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Specializes in Pediatrics (Burn ICU, CVICU).
this is untrue and incorrect. its patent ran out and because of lagging sales was discontinued, people were buying other cheaper meds that are avail now. it was once widely used for add.

he (and his doc) are very well aware of the hepatic effects being reported and each has figured it is much safer than the narcolepsy that he suffers from, and this is his only relief. he has tried several other treatments with no relief. evidently the risks are with children not adults (also used to treat add). i am certain her appreciates your concern but there is nothing else out there for him.

in fact, the fda is considering it as a compassionate investigational new drug (ind) -- specifically because there is no other medication like it. they (the fda) contacted him about getting a manufacturer to make it but we all know that this could

the guy is willing to travel around the world to get this stuff (if it were avail!), can't anyone try to call a few local pharms and see if they have a stock?

pretty please?? this could mean a huge difference in the quality of this man's life.

actually i think the poster is correct:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#cylert

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This was withdrawn from the US market almost three years ago, in March 2005. There isn't any around.

http://www.rxlist.com/cgi/generic/pemoline.htm

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Specializes in Pediatrics (Burn ICU, CVICU).
I'm sorry but your post is untrue and incorrect.

http://www.fda.gov/cder/drug/InfoSheets/HCP/pemolineHCP.htm

" ... FDA ALERT [10/2005]: Liver Injury Risk and Market Withdrawal

The Agency has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of this drug. In May 2005, Abbott chose to stop sales and marketing of Cylert in the U.S. All generic companies have also agreed to stop sales and marketing of this product (Pemoline tablets and chewable tablets). ..."

I urge your friend and his MD to aggressively pursue alternate therapies.

Looks like we posted this at the same time;)

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The manufacturere stopped manufacturing this medicine Several months before the safety alerts. It was never pulled from the market from FDA at all. They also state that the drug will be available until supplies run out, which they are almost there. Did you even read the links???

http://www.fda.gov/cder/drug/InfoSheets/HCP/pemolineHCP.htm

Cylert will remain available through pharmacies and wholesalers until supplies are exhausted; no additional product will be available.

There are actually still pharmacies with it available and this man is desperately trying to get the last remaining stock. People have been calling all over the place for him and have been finding a few here, a bottle there, etc. So it is still available for sale.

Again, I apreciate your concern for this man's health but his doctor is confident and monitoring him, and he is confident and so is the FDA, obviously if they are reconsidering for a CID as posted above. Remember the FDA contacted him, not the other way around.

There is no other medicine that works for this man. He has tried everything, trust me.

Honestly I am fairly disapppointed with the posts above and no offers to help. Can't you just call and see if the local pharmacy or hospital still has a bottle kicking around?

This has been posted as well on a worldwide non medical site this gentleman has been a member of for a very long time and the outpouring has been absolutely amazing. People have literally taken on calling whole zip codes to help this man. They are successful with about 1 in a hundred pharmacies and his doc has helped him secure that last bit remaining.

I was so hoping and praying for such a response here. I had told him I would post here and I was CERTAIN that the nurses and medical personnel on here would be more than happy to check.

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i'm sorry but your post is untrue and incorrect.

http://www.fda.gov/cder/drug/infosheets/hcp/pemolinehcp.htm

" ... fda alert [10/2005]: liver injury risk and market withdrawal

the agency has concluded that the overall risk of liver toxicity from cylert and generic pemoline products outweighs the benefits of this drug. in may 2005, abbott chose to stop sales and marketing of cylert in the u.s. all generic companies have also agreed to stop sales and marketing of this product (pemoline tablets and chewable tablets). ..."

i urge your friend and his md to aggressively pursue alternate therapies.

i beg to differ, it is not untrue or incorrect. call the fda or the manufacturers if you wish. everything i said was the truth.

look at the dates of the alert and the dates the drug was no longer manufactured (months before the fda posted the alert). my post is true and accurate.

tylenol has caused more cases of liver failure than this med and if you look at the particular cases, i believe they are children, not adults.

as i said, the manufacturer pulled it from the market, not the fda. its patent was running out, and the drug was barely being used anymore.

yes there are concerns over its safety. did the company fight the fda? of course not, the med was already no longer being made and no longer profitable for them at that time.

as i already said, it is still available in pharmacies dotting the us.

this man and his doc are very well aware of all of this. he is not seeking any medical advice or opinions, he is only desperately seeking the only relief he has ever found.

this poor man has called all the world and talked to top execs at the pharma companies as well been contacted by the fda about getting someone to start up manufacturing.

interestingly, during this whole phone campaign that has been going on, it has been discovered that many people have done the same thing he has done to find the meds.

it is a shame that not one of you would even consider checking to see if stock was available in your area.

can you all do me a favor and just stop trying to be right and just try to help or not?

i will be calling every hospital and pharmacy in new hampshire tommorrow as it is my day off.

btw- many kaiser facilities have had some still but to call people get a switchboard and not the pharms direct and if anyone can reach one direct, that would be wonderful.

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Specializes in OB, M/S, HH, Medical Imaging RN.

Honestly I am fairly disapppointed with the posts above and no offers to help. Can't you just call and see if the local pharmacy or hospital still has a bottle kicking around?

As members we are not allowed to participate in anothers healthcare in such a way.

If there is such a small supply of this, no longer available, medication what is the man going to do when there is no more? He'll have to consult with his doctor to find an alternative. It may be better that he go ahead and find an alternative now.

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Specializes in Emergency & Trauma/Adult ICU.

You should be aware that any pharm company with any business sense at all "voluntarily" pulls a drug from the market before the FDA does -- an involuntary recall spells huge negative press for the company with accompanying damage to its stock value.

The safey alerts, including a black box warning, date to at least 1999, as indicated on the FDA's website. http://www.fda.gov/medwatch/SAFETY/1999/cylert.htm

Your friend may very well be in a very distressing situation. However, to answer your question bluntly, no, I will not participate in obtaining quantitities of a Schedule IV CNS stimulant drug which has been shown in clinical studies to carry a significant risk of liver damage -- for a person I have no knowledge of who claims that FDA contacted him and/or his MD directly to somehow re-track Cylert as an investigational new drug.

I'm sorry -- I do not find this situation to be credible, as it has been presented.

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Specializes in Jack of all trades, and still learning.

I checked Martindales Drug Reference online and thought I had found two sources. However when I checked the companies' sites, neither listed them. I suggest that nowhere is willing to market this drug anymore. Martindales listed sites from Israel to South Africa to anywhere you can imagine.

Thus I think your friend really should look for another medication to help with his condition. If there are still quantities that can be found, then they will soon run out and your friend will find himself in the same predicament later on. Sorry I couldn't be of more help.

You've got to wonder why no other country not just the US are unwilling to either market or sell it...

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