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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by Ame Sans Vie on November 7, 2005, at 21:54:57
This was news to me, though it was first reported on October 24. I was aware that Abbott stopped manufacturing Cylert back in May, but this complete, apparently voluntary, withdrawal of this drug from the market sort of angers me. I mean, magnesium pemoline did not work for me, nor do I imagine there are many (if any) folks here on PB who take this stuff. But to deprive it of those to whom it *has* been a miracle medication due to thirteen reports of liver failure in thirty years?
Anyway, here's the article (and a link to it):
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http://www.usatoday.com/news/nation/2005-10-24-adhd-withdrawal_x.htm?csp=34
FDA WITHDRAWS APPROVAL FOR ADHD DRUG
WASHINGTON (AP) — The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency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.
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~Michael
Posted by mr. matt87 on November 7, 2005, at 22:22:47
In reply to News: Pemoline To No Longer Be Manufactured, posted by Ame Sans Vie on November 7, 2005, at 21:54:57
I thought they withdrew that in 1999.
I have asked about Cylert before, my doctor told me to many complications.
You truly have tried many medications.
Matt
Posted by Chairman_MAO on November 9, 2005, at 8:15:29
In reply to News: Pemoline To No Longer Be Manufactured, posted by Ame Sans Vie on November 7, 2005, at 21:54:57
It did work for me, but not as well as d-amphetamine. It was not signficantly less effective than Ritalin, however. But I seem to respond to many things differently than most.
Note I had to get the dose up to at least 112.5mg/day, and it had more side effects than other stimulants. It caused almost no elevation of heart rate.
I have taken up to 500mg of pemoline before. It can be useful, but the other stimulants are better. Of course, that is why it was schedule IV. The liver thing is ludicrous; Depakote is probably just as bad.
This is the end of the thread.
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