FDA Withdraws Approval for ADD Drug
Mon Oct 24, 8:37 PM ET
WASHINGTON - The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency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.