ADHD drugs shouldn't have strongest warning labels, federal advisory panel says

Wednesday, March 22nd 2006, 8:37 am

By: News On 6

WASHINGTON (AP) _ Ritalin, and other drugs for attention deficit hyperactivity disorder should not have to carry the government's strongest warning about potential cardiovascular and psychiatric risks, a federal advisory panel says.

Instead of having the ``black-box'' warnings, the drug labels should caution users about possible dangers in plain language that they can understand, the Food and Drug Administration pediatric advisory committee recommended Wednesday.

By rejecting the black-box warnings in a consensus decision, the FDA advisers broke with another committee that voted just last month to include them on some ADHD drugs, including Strattera, which is made by Eli Lilly & Co.

The FDA was poised Wednesday to follow the latest recommendations.

``I think we are likely to follow them, yes,'' Dr. Robert Temple, director of the FDA's office of medical policy, said.

Any updated language may not appear on labels until pharmaceutical companies begin using a recently adopted format, something that could take several years. And the FDA may yet require black-box warnings on stimulants to treat ADHD that would alert adults to increased risk of heart attacks, strokes and other similar problems, Temple said.

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 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 regarding their potential cardiovascular risk.

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 of the drugs, which also include Adderall, could cause more harm than good, some experts told the panel.

``I suggest confusion, polarizing viewpoints, initial press hysteria. But then what?'' said Julie Zito, a University of Maryland associate professor in pharmacy and psychiatry.

The FDA has struggled since last year with the question of how to communicate the potential risks associated with ADHD drugs. It now appears likely the warnings will come in the form of highlighted language on drug labels, as well as guides distributed to patients.

Psychiatrists and mental health advocates said leaving the disease untreated could rival the risks the drugs may pose.

``It is important to not let the discussion of ADHD medications overshadow the public health crisis of untreated mental health disorders in children,'' said Cynthia Wainscott of the National Mental Health Association. Her 16-year-old granddaughter has ADHD.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.

Novartis believes current Ritalin labels are adequate, company medical safety director Dr. Todd Gruber said.

A different FDA panel planned to consider on Thursday an application by Cephalon Inc. to sell its sleep-disorder drug Provigil, or modafinil, as an ADHD treatment for children.

The FDA wants members of its psychopharmalogic drugs advisory committee to examine that request, including whether serious skin rashes seen in children treated with modafinil should merit special warnings, follow-up studies and steps to limit the risk.