Hyperactivity

...ba href=/hyperactivity/a/b disorder should bear the strongest type of warning of the potential cardiovascular and psychiatric risks they pose.

The consensus move by the Food and Drug Administration's pediatric advisory committee leaves in doubt whether the agency will require the so-called "black-box" labels on the drugs.The committee, without voting, did recommend adding more information to the labels for the benefit of doctors, patients and parents.The agency isn't required to follow the advice of its advisory committees, but usually does.Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.Psychiatrists and others had urged the committee to move cautiously before recommending strengthened warnings of heart attacks, hallucinations and other potential risks associated with the drugs.In February, the FDA's Drug Safety and Risk Management advisory committee voted to recommend the agency add the strongest possible warning to some of the drugs.The FDA then asked the pediatric panel to examine that same issue, as well as reports that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug.Adding black-box warnings to some or all the drugs, which include Ritalin, Adderall and Eli Lilly and Co.'s Strattera, could cause more harm than good, some experts told the panel.The FDA has struggled since last year with the question of how to communicate the potenti...

...ba href=/hyperactivity/a/b disorder bear the strongest type of warning of the cardiovascular and psychiatric risks they pose.The consensus move by the Food and Drug Administration's pediatric advisory committee leaves in doubt whether the agency will require the "black box" labels on the drugs, which include Ritalin.

The panel, in recommending language on the labels that is easier to understand, broke with another committee that recommended last month that the drugs include the more dire warnings.

Well, Well, Well And the perfect kids' beverage is...Mind the agenda...A legal nightmare...Now that's depressing...

Well, Well, Well: A Log of Notes and Observations #delicious_display { display:none ; color:#333333 ; background-color:#EEEEEE ; padding:4px ; padding-top:0px ; border:1px dotted #0D3159 ; } Save & ShareTag This Article Saving options1.

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Tag This Article The pediatric advisory committee, without voting, did recommend adding more information to the labels for the benefit of doctors, patients and parents."I wouldn't use the word 'tougher,' " said the panel's chairman, Robert Nelson.

" 'Clearer.' "The agency is not required to follow the advice of its advisory committees but usually does.Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a manager of drug benefit programs.Psychiatrists and others had urged the committee to move cautio...

...ba href=/hyperactivity/a/b disorder bear the strongest type of warning of the cardiovascular and psychiatric risks they pose.

Well, Well, Well And the perfect kids' beverage is...Mind the agenda...A legal nightmare...Now that's depressing...

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Tag This Article The $35 million taxpayer-funded study was the largest trial of its kind ever conducted.

It provided what industry-sponsored trials have rarely captured: Rather than merely ask whether patients are getting better, the study asked what patients most care about - whether depression can be made to disappear altogether.The study has been eagerly awaited by physicians, patients and the pharmaceutical industry.

According to government statistics, depression afflicts 15 million Americans a year.

About 189 million prescriptions for antidepressants were written last year, and the disease costs the nation $83 billion annually because of treatment costs, lost productivity, absenteeism and suicide.David Rubinow, a professor and the chairman of the psychiatry department at the University of North Carolina at Chapel Hill, said the results are an "illuminating and disconcerting" window into the...