Posted on 10/24/2005 4:46:34 PM PDT by neverdem
WASHINGTON -- The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency officials said Monday.
The move means drug manufacturers will no longer produce generic versions of pemoline, which was developed by Abbott Laboratories and sold under the name Cylert. Abbott discontinued the drug earlier this year, but generic versions have remained available.
FDA is not recalling the drug, instead allowing pharmacies to sell their remaining stock as doctors still using it switch patients to alternative treatments, the agency said in a statement.
The lack of a recall drew fire from the consumer advocacy group Public Citizen.
"It is reckless and insensitive to the health and lives of children and adults using this drug for the FDA and the involved drug companies to fail to institute an immediate recall of these dangerous products," said Drs. Sidney Wolfe and Peter Lurie, who lead the organization's Health Research Group, in a letter to the FDA.
In a statement, the FDA said it has 13 reports of liver failure resulting in transplant or death among people who took the drug, which has been available for 30 years. There are additional reports of less serious problems.
Although that is a small number, it is well above what the normal rate of such problems among the general population, the FDA said.
"FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits," the agency statement says, noting that alternative treatments for ADD have come on the market since pemoline was introduced.
The drug acts as a stimulant to the central nervous system.
dexadrine has been effective for ADD for decades. The only problem with it is that it is available in a generic form and very inexpensive. Same for a few other ADD drugs.
"FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits,"
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Oh? What about patients and doctors? Does their opinion count for anything. Why won't our elected 'conservative' government abolish the hurtful FDA?
http://www.fdareview.org/harm.shtml
FDA tyranny alert
All I can say is "Oh, excrement!"
They've done it to us again -- how many of us have written Cylert over the years? I was adamant about procedure, including neurology consult, school diaries, etc. (Except for one or two families who couldn't afford the neuro consult.)
Let's see, Texas law makes me liable for minor's injury 2 years after majority or after they discover the injury or is it 2 years after I die?
Yep, lets make more meds over the counter, too. Well, at least I wouldn't have the liability of writing the script.
I remember my doctor tried to convince my parents I had ADHD because one of my teachers said I wasn't paying attention in class. (I was in fourth grade, the teacher was a witch, and couldn't teach worth a d*mn. For a kid, it was impossible to listen to her shrill, mindless dribble.) The doctor got my parents to put me on all kinds of pills which did nothing except make me so ill if I hadn't quit taking them I probably would have died or suffered serious damage to one or more organs. Thankfully I survived but still wonder what health surprises might be waiting in my future thanks to the drugs.
And don't forget the shark personal injury lawyers; they silently have major influence as to whether a drug stays on the market or not.
It doesn't work for all, but my father dealt with my ADD with a leather belt. ...quick recovery.
I don't know if this article is leaving something out, but 13 cases of liver failure over a 30 year period seems like an acceptable risk. Is there more to this, do you know?
Some people have ADD, but about 90% have never been slapped hard enough to GET their attention.
This all came about when the welfare programs started paying families extra for kids having "problems".
"Now honey, when we're in the Dr's office, be sure to act the nut so Mama can get more money and we can sell your prescription for even more."
You couldn't pretend to take the pills? Your parents checked?
If the plan of your SOAP note of your HIPAA compliant electronic medical record includes an OTC drug, do you think you'll have less liability?
Paying attention in class when it is needed, is much more important than liver failure....sarcasm off.
ADHD exists.
My 5 year old daughter went to the bathroom 5 times during Batman. We had some injury at least every 6 months the first 7 or 8 years of her life. I can't remember seeing her asleep between 6 months and 13 months. She would throw fits that only ended when she fell asleep exhausted. We never put her on meds because she was happy, got along with everyone and made good grades, except in conduct. After she was grown she said she wished we had put her on meds so she could have made the honor roll sooner and been part of the school crossing patrol. (Which confirmed my decision, in my mind - who wants their kid on the street corner before and after school, funny vest or not?)
On the other hand, I've had patients who didn't like themselves and who weren't allowed to play at anyone else's house - if they had friends. After beginning meds, they could control their impulses and began to get along with others. Grades and home life would improve. The children began to like themselves.
I tried but they made sure I took them. Only when I became obviously ill did they believe me that the pills made me sick. Until that time they thought I didn't want to take the pills because they believed I felt the pills meant I was stupid or something. Thankfully it has been 18 years or so since that happened and I don't think I've suffered any permanent damage but of course there is no way to be sure.
Er, coexerj145, coins only have two sides. (not four)
Five-year-old girls are not interested in Batman. (How many times would she go to the bathroom during a movie about pretty ponies?)
Well, either your story is made up, or your doctor is a complete and utter moron... When you sit around not paying attention in class, that is not ADHD, it is ADD (that's ofcourse if it's anything at all, and has gone above and beyond the normal everyday behaviors of a kid...)
And the swift kick in the ass, leather strap crowd needs to get their facts before spouting off...
thank you
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