Group Seeks FDA Ban on ADHD Drug
The U.S. Food and Drug Administration should immediately halt the sales of an attention deficit hyperactivity disorder (ADHD) drug and ban it from the market because the drug is known to cause liver failure, the consumer advocacy group Public Citizen charged Thursday.
In a petition presented to the FDA, Public Citizen noted that the drug pemoline (Cylert) is known to have caused at least 21 cases of liver failure, including 13 cases that led to liver transplantation or death.
The drug's unfavorable risk-to-benefit ratio has led to its market withdrawal in Canada and the United Kingdom, the group said. The FDA, however, mandated that the drug, a central nervous system stimulant made by Abbott Laboratories and approved in 1975, carry two separate black-box warning labels. A 2002 FDA study found that those warnings were ineffective in reducing the drug's risks, the group claimed in a prepared statement.
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