Abbott Says Withdrawing Attention Deficit Drug

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Abbott Says Withdrawing Attention Deficit Drug

Thu Mar 24, 6:53 PM ET

WASHINGTON (Reuters) - Abbott Laboratories Inc. said Thursday it was halting

sales of a 30-year-old attention deficit drug that a consumer group

complained was too dangerous to stay on the market.

Abbott decided to discontinue the drug, Cylert, because of declining sales,

Abbott spokeswoman Brotz said. The drug's sales this year will be

less than $1 million, she said.

Brotz declined to comment on charges made earlier Thursday from consumer

group Public Citizen that the drug had caused 21 cases of liver failure,

including 13 that were fatal or required transplants.

" We're in the process of discontinuing it ... but that's because of

declining usage and sales and because there are generics available, " Brotz

said.

Generic companies sell copycat versions of the drug under the name pemoline.

Public Citizen asked the U.S. Food and Drug Administration (news - web

sites) on Thursday to ban Cylert and its generic competitors immediately.

Generic companies can still sell their versions even after Abbott pulls the

medicine, unless the FDA (news - web sites) determines the drug was

withdrawn for safety reasons.

A petition from Public Citizen said Britain and Canada already had pulled

the drug off the market, while the FDA opted to strengthen warnings twice

and allow sales to continue.

The warnings failed to increase doctors' monitoring of liver function in

patients treated with pemoline, which offers no benefit over other

therapies, the group said.

" In light of this evidence of unique liver toxicity without evidence of

unique therapeutic benefit, we contend that the only responsible course of

action is to remove this dangerous drug from the market, " Public Citizen

said.

Cylert is a stimulant that was approved to treat attention deficit

hyperactivity disorder, or ADHD, in 1975. Last year, about 117,000

prescriptions for the drug were filled in the United States, according to

Public Citizen.

FDA spokeswoman Cruzan said the agency would carefully review the

petition, which also was signed by Dr. Fredric , a psychiatrist and

ADHD specialist at the Washington University School of Medicine.

Public Citizen has filed several petitions with the FDA seeking to have

various drugs withdrawn.

Earlier this month, the FDA denied a petition from Public Citizen asking for

a ban on AstraZeneca Plc's cholesterol treatment Crestor.