Contributed by Carla Sharetto| 25 March, 2005 23:20 GMT
'In the absence of data demonstrating that pemoline has any unique therapeutic benefit over other, safer drugs for the treatment of ADHD, there is no responsible basis for keeping this unacceptably dangerous drug on the market.'
Abbott Laboratories has withdrawn its 30-year old attention deficit hyperactivity disorder (ADHD) drug Cylert (pemoline) from the market, reportedly because of declining sales. However, the action came after a nonprofit consumer advocacy group, Public Citizen, sent a petition to the US Food and Drug Administration detailing the drug's dangerous, sometimes lethal, side effects.
Abbott reportedly expects this sales of Cylert will decline to less than $1 million in 2005, partly because of competition from generic equivalents. Unless FDA acts to ban the drug altogether, the generic versions may continue to be prescribed and sold. Following is the text of the Public Citizen petition. Citations have been omitted.
ADHD Drug Should Be Removed from Market
March 24, 2005
Lester Crawford, DVM, Acting Commissioner
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Crawford,
Public Citizen, representing more than 150,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately remove from the market pemoline (CYLERT |
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