Abbott Says Withdrawing [30 year old] Attention Deficit Drug

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Sun, 27 Mar 2005 19:06:53 -0000

[sSRI-Research] Abbott Says Withdrawing [30 year old]

Attention Deficit Drug

 

 

 

 

[-- this took 30 years to get off the market????]

 

Abbott Says Withdrawing Attention Deficit Drug

 

http://news./news?

tmpl=story & cid=594 & u=/nm/20050324/hl_nm/health_abbott_cylert_dc & printe

r=1

 

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 Melissa 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determines the drug was withdrawn for safety reasons.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 Susan Cruzan said the agency would carefully review

the petition, which also was signed by Dr. Fredric Solomon, a

psychiatrist and ADHD specialist at the George 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.