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Ritalin and Adderall to get Black Box Warning

–February 10, 2006

The FDA's advisory committee has voted that all labeling for ADHD drugs Ritalin and Adderall should carry a black box warning to inform consumers about the serious risks of sudden death and cardiovascular complications. The committee made this decision on February 9, 2006 by an eight-to-one vote.

The FDA, who convened the advisory committee to determine how to properly study the risks associated with ADHD drugs, did not originally request this ADHD drug warning recommendation. This added recommendation may indicate the strength of the committee's findings regarding the link between ADHD drugs and potentially fatal side effects.

"We can't discuss future strategies, we need to discuss what needs to be done now about the risks and informing people about them," argued Cleveland Clinic heart specialist Steven Nissen, a member of the FDA advisory panel for ADHD drug safety. He believes the Ritalin and Adderall black box warning must be issued now to warn people about the possible ADHD drug side effects. If researchers later find no causal link between the over 51 deaths reported in connection with these medications, then the black box warning can be removed.

This is the THIRD meeting the FDA has convened in the last two years over cardiovascular side effects of ADHD drugs.

Approximately TWO MILLION prescriptions of ADHD medications are administered to children EVERY MONTH in the United States. For adults, approximately ONE million prescriptions of drugs like Ritalin and Adderall are prescribed each month. Due to this drug's high abuse potential, thousands of consumers without a valid prescription may be consuming these potentially lethal drugs. This means that well over three million people may be at risk of serious ADHD side effects every month.

The need for adequate warnings is crucial.

The FDA panel recommended that the following central nervous system stimulants receive a black box warning to indicate possible heart and sudden death risks:

  • Shire Pharmaceutical's Adderall
  • Novartis AG's Ritalin
  • Johnson & Johnson's Concerta
  • Novartis' Focalin
  • Tyco and Alliant's Methylin

For more information on Adderall and Ritalin, please contact us to confer with an attorney.


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