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FDA withdraws approval for ADHD drug Cylert
WASHINGTON (AP) — The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency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 (pemoline). 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.
WASHINGTON (AP) — The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency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 (pemoline). 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.
Funny commentary on Cylert by a parental unit:
Cylert (pemoline). The ADHD medication of last resort, used only if nothing else will get that goddamn kid to sit still and shut the **** up for five minutes. This is the other med with which we have no experience, but for good reason.
Concerta we have yet to try, while Cylert has a big black-box warning about liver failure and it states right in the patient information sheet, "CYLERT should not ordinarily be considered as first line drug therapy for ADHD." That's drug company speak for "try everything else first." It figures that it's one of the few drugs in this guide that might actually be safe to use during pregnancy.
Oh how the universe loves to play these little jokes on us. It won't harm your unborn child, but it might kill you first. Rather, it might kill that goddamn kid who won't shut the hell up for five freaking minutes.
Reports of adults dropping dead from liver failure are a lot harder to find, but adults might be getting more reliable liver panels. Other than one guy taking it for narcolepsy who had an enlarged prostate, no freaky side effects (not counting the sudden deaths from liver failure).
Concerta we have yet to try, while Cylert has a big black-box warning about liver failure and it states right in the patient information sheet, "CYLERT should not ordinarily be considered as first line drug therapy for ADHD." That's drug company speak for "try everything else first." It figures that it's one of the few drugs in this guide that might actually be safe to use during pregnancy.
Oh how the universe loves to play these little jokes on us. It won't harm your unborn child, but it might kill you first. Rather, it might kill that goddamn kid who won't shut the hell up for five freaking minutes.
Reports of adults dropping dead from liver failure are a lot harder to find, but adults might be getting more reliable liver panels. Other than one guy taking it for narcolepsy who had an enlarged prostate, no freaky side effects (not counting the sudden deaths from liver failure).
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