Hyperactivity

...ba href=/hyperactivity/a/b disorder are overused.

Still, researchers and clinicians say they are far more worried about untreated mental illness than any overuse of medications.© 2006 The Washington Post Company Print this Email this MORE FROM MENTAL HEALTHMore adults, fewer kids on ADHD drugs.

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Mar 22, 2006 Jennifer Coates WNCT-TV9 Printer friendly format E-mail this story More Local News A Federal advisory committee has rejected recommending that Attention Deficit ba href=/hyperactivity/a/b or ADHD drugs bear stronger warnings.

Millions of kids take the medication every day.

But now, drugs like Ritalin, Adderall, and Straterra are being linked to psychosis and heart problems.

Recently the FDA has seen an increase in the number of heart and psychiatric problems linked to the pills.

Still, the government says it’s safe.

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...ba href=/hyperactivity/a/b disorder, FDA will ask the committee.

The committee will also consider how concern over potential skin reactions with the medication, including Stevens Johnson Syndrome, should be addressed in labeling and whether the sponsor should be required to undertake post-marketing studies, FDA briefing documents state.

Concern about skin reactions and other potentially serious adverse events related to Sparlon (modafinil) administration in children led FDA to issue an “approvable” letter for the sNDA on Oct.

20.

The initial FDA clinical review, prepared by Psychiatric Products Division Medical Officer Glenn Mannheim in September 2005, recommended a non-approval action based on reports of three clinically important cases of rash (one case of SJS), an observed case of possible Reye’s syndrome and three instances of markedly elevated liver enzymes.

In addition, 52 subjects dropped out of trials due to serious and non-serious psychiatric adverse events.

Mannheim noted that suicidality, depression, agitation, psychosis and phobias occurred only in patients on modafinil.

Although the drug was found to be efficacious, Mannheim concluded that “the risks associated with the use of Provigil are greater than the benefits and preclude the safe use of this drug in the intended population for ADHD.” Modafinil is currently marketed as Provigil for the treatment of narcolepsy.

Cephalon is seeking an indication to treat ADHD in children ages 6-17 years.

Furthermore, Mannheim recommended ...