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Labels Strengthened On ADHD Drug

Added August 8th, 2006

The labelling on an ADHD drug manufactured by Shire has had the warning on its labels strengthened to reflect the risk of cardiovascular and psychiatric problems that could arise from taking the medication. The warning labels have been strengthened on both Adderall and Adderall XR.

The changes have been described as ‘Class labelling revisions’ and were requested by drug regulators back in May. All manufacturers of this type of drug were asked in May to strengthen the warning labels on their drugs to reflect these heightened risks.

The FDA had told manufacturers of these drugs in May that warnings needed to be strengthened "with regard to serious cardiovascular events and psychiatric events." An official from the FDA went on to state: "To date, all sponsors of stimulant medications have replied and the responses are currently under review."

The revised labeling on the drugs now clarify which patients should not be given the drugs based on any existing medical conditions from which they may be suffering.

Labels Strengthened On... | Printable Version (Opens In New Window)

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