WASHINGTON (Reuters) – Liver problems linked to Abbott
Laboratories Inc.’s discontinued attention deficit drug Cylert
and other generic versions make the drug too dangerous for the
U.S. market, the Food and Drug Administration said on Monday.
“The agency has concluded that the overall risk of liver
toxicity from Cylert and generic pemoline products outweighs
the benefits of this drug,” the FDA said in a warning posted on
its Web site.
In March, Abbott said it would no longer make the
30-year-old drug due to declining sales, but consumer advocates
had argued it was too dangerous to be sold. Generic makers also
agreed to halt sales, according to the agency.
“The decision to discontinue Cylert was based on commercial
reasons. Usage of pemoline products has declined significantly
over the years,” Laureen Cassidy, a spokeswoman for Abbott,
said.
FDA officials said Cylert would remain available until
current supplies ran out. Doctors who prescribe it or its
generic counterparts “should transition their patients to an
alternative therapy,” they said in a statement.
The agency said it received 13 reports of liver failure
that led to patient death or an organ transplant. The rate
involving patients taking pemoline was 10 to 25 times higher,
it said.
The fact that there are “multiple other drug treatments”
for Attention Deficit Hyperactivity Disorder, or ADHD, also
factored into the agency’s decision, the statement said.
The FDA’s warning was posted online at
http://www.fda.gov/cder/drug/InfoSheets/HCP/pemolineHCP.htm
Abbott shares were up 29 cents, or less than 1 percent, at
$43.03 in midday trading on the New York Stock Exchange.
(Additional reporting by Julie Steenhuysen in Chicago)
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