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U.S. Advisors Recommend Safety Warnings Against Attention Deficit Drugs

Posted on: Saturday, 11 February 2006, 09:00 CST

U.S. advisors recommend safety warnings against attention deficit drugs

WASHINGTON, Feb. 9 (Xinhua) -- The United States Food and Drug Administration (FDA) advisors on Thursday recommended applying the most serious type of safety warnings to Ritalin and other drugs used to treat attention deficit hyperactivity disorder (ADHD).

The advisory committee said ADHD drugs, including amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate, should use the "black box" safety warnings, the most serious type used in the United States.

The advisors also recommended to the FDA a requirement that the drugs' labelling include a medication guide for patients and parents.

The FDA, which usually follows the recommendations of its advisory committees, has yet to make a final decision.

Each month about 2 million children and 1 million adults are prescribed the drugs by doctors.

The panel vote came one day after the FDA released a report detailing the deaths of 25 people treated with ADHD drugs. The fatalities occurred between 1999 and 2003 and involved 19 children.

The regulatory agency also reported 54 cases of serious cardiovascular problems, including heart attacks, strokes, hypertension, palpitations and arrhythmia, in adults and children on ADHD medication.

The advisors voted eight to seven in favor of the most serious safety warning on ADHD drugs, with one abstention. But they agreed that the link between the drugs and sudden deaths or cardiovascular problems remained unclear.

Source: Xinhua News Agency - CEIS

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