FDA: ADD/ADHD drugs killing too many kids

[Guest guest]

Just in

case anyone still thinks ADD/ADHD drugs are safe, the FDA is looking at new

ways to study the drugs since so many kids keep DYING from them.

FDA

to Examine New Ways to Study ADD Drugs

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Jan 4, 7:35 PM (ET)

By ANDREW BRIDGES

WASHINGTON (AP) - Reports of sudden deaths, strokes, heart attacks and hypertension in both

children and adults taking drugs to treat attention deficit hyperactivity

disorder are spurring new government study into the medications' safety.

Sales of drugs to treat ADHD have increased

sharply in recent years, with use growing at a faster rate among adults than

children, according to a recent study by Medco Health Solutions, a prescription

benefit manager. Spending on ADHD drugs soared from $759 million in 2000 to

$3.1 billion in 2004, according to IMS Health, a pharmaceutical information and

consulting firm.

The Food and Drug Administration said it had

received reports of what it called " serious adverse events " -

including deaths - in association with the therapeutic use of the drugs. The

agency considers the reports " rare though serious, " FDA spokeswoman

Bro said Wednesday.

The FDA's Canadian counterpart, Health Canada, yanked

the ADHD drug Adderall XR from the market for six months last year in response

to reports of 20 sudden deaths and 12 strokes in adults and children using the

drug. A number of the cases involved children with structural heart defects.

The panel eventually concluded there was

inadequate evidence of increased harm from Adderall XR compared with other

available therapies - a conclusion the FDA also reached based on data on hand.

Now the U.S. regulatory agency is asking

its Drug Safety and Risk Management advisory committee to examine ways of

studying further the potential cardiovascular risks of the drugs. The few

studies that have looked at longer-term use of ADHD drugs provide little

information on those risks, the FDA said.

" It almost sounds like cox-2 inhibitor

redux, " said committee chairman Dr. Gross, referring to cox-2

painkillers like Vioxx and Bextra pulled from the market because of evidence

they can raise the risk of a heart attack or stroke.

The committee is to meet Feb. 9 and 10 in Gaithersburg, Md.

" The issue of drug treatment of attention

deficit disorder in children has been a controversial one without this issue of

cardiovascular risk too. It adds another concern to what will certainly be an

interesting conversation, " said Arthur Levin, the FDA committee's consumer

representative.

A posting to the FDA Web site did not identify

any of the drugs by name. However, the most commonly used ADHD drugs include

Adderall XR, made by Shire Pharmaceuticals, and Ritalin, made by Novartis

Pharmaceuticals Corp. Various other companies make generic versions of Ritalin

as well.

Shire spokesman Cabrey said the

company hadn't been told of the meeting but added it may send representatives.

Novartis did not immediately return a call seeking comment.

The committee's Feb. 10 meeting will include

updates on FDA actions on cox-2 drugs as well as a recently begun patient,

doctor and pharmacist registry program for the anti-acne drug Accutane and its

generic competitors.

Separately, the committee also will discuss

the FDA's Drug Safety Oversight Board, an internal, government employee-only

panel created nearly a year ago.

The board is supposed to monitor FDA-approved

medicines once they're on the market and update physicians and patients with

emerging information on risks and benefits.

Gross said he had concerns about the board's impartiality

and independence, as well as its relationship to his committee and the very

similar work it does.

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On the Net:

Food and Drug Administration: http://www.fda.gov

Medco Health Solutions: http://www.medcohealth.com/