FDA panel urges ADHD drug warning label
Advisers recommend the regulatory agency require 'black box' for medicines used primarily by kids.

WASHINGTON (CNN) - A Food and Drug Administration advisory committee has recommended that the strongest possible safety labels, or "black box" warnings, be added to medicines used to treat attention deficit hyperactivity disorder, after reports that 25 patient deaths may be linked to their use.

Nineteen of those deaths were children, who often take drugs such as Ritalin, made by Novartis (Research), to control behavior that is restless, impulsive and distracted.

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The drugs, taken by millions of patients, also may increase the risk of cardiovascular problems, according to FDA data.

Some of the medicines are amphetamines that already carry warning labels about possible cardiovascular problems, but they are usually aimed at people with existing heart problems.

The FDA does not have to follow the recommendations of their advisory committees, but usually does.

The black box warnings are meant to highlight special problems and potential side effects. The committee said it feels the increased warnings are warranted, until further studies can be done.

The scientific advisers want to determine whether the drugs pose risks, and how much, according to Dr. David Graham, associate director of the FDA's Office of Drug Safety.

In addition to Ritalin, the drugs that would be relabeled include Strattera, Concerta and Adderall. Adderall is an amphetamine; the other medicines are methylphenidates.

While some parents blame the drugs for their children's deaths, Susannah Budington said they are a godsend for her 12-year-old daughter, Allison, who began taking them six years ago.

"Without medication, really, the ADHD severely impacts her life, her ability to stay focused, her ability to do well in school," Budington told CNN. She said Allison has had no side effects.

U.K.-based Shire Pharmaceuticals, the maker of Adderall XR, which has 25 percent of the market share, said its medicine already carries a warning, and it is committed to working with the FDA to make any needed changes.

-- CNN Medical Correspondent Christy Feig contributed to this report.

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Most stock quote data provided by BATS. Market indices are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer. Morningstar: © 2018 Morningstar, Inc. All Rights Reserved. Factset: FactSet Research Systems Inc. 2018. All rights reserved. Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor's Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2018 and/or its affiliates.