CNNMoney.com
Companies Economy International Corrections Pre-market Trading After-hours Trading Winners/Losers/Actives Bonds Currencies Commodities World Markets Money Magazine Real Estate Taxes Jobs Ask the Expert Money 101 Autos Mutual Funds The Help Desk Loan Center Best Places to Live Ask the Expert Ultimate Guide to Retirement Retirement Calculators Rules of Retirement Best Funds Best Places to Retire Fortune Brainstorm Tech Apple 2.0 Blog Big Tech Blog Sectors and Stocks Tech Talk Resource Guide Small Business Makeovers Questions & Answers Small Business Video 100 Best Places to Launch FSB 100 Fortune Small Business Fortune 500 Brainstorm Tech Investing Management C-Suite Rankings Main Create Portfolio Edit Portfolio Create Alerts Edit Alerts
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.

The antidepressants to watch in '06
Wyeth, Lilly, Forest Labs lead sluggish antidepressant market.(Full story.)

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.

---------------------

Click here to read about three hot and risky biotechs. Top of page

YOUR E-MAIL ALERTS
Follow the news that matters to you. Create your own alert to be notified on topics you're interested in.

Or, visit Popular Alerts for suggestions.
Manage alerts | What is this?
© 2009 Cable News Network. A Time Warner Company. All Rights Reserved. Terms under which this service is provided to you. Privacy Policy. Advertising Practices.
Copyright © 2009 BigCharts.com Inc. All rights reserved. Please see our Terms of Use.
MarketWatch, the MarketWatch logo, and BigCharts are registered trademarks of MarketWatch, Inc.
Intraday data provided by Interactive Data Real-Time Services and subject to the Terms of Use.
Intraday data is at least 20-minutes delayed. All times are ET.
Historical, current end-of-day data, and splits data provided by Interactive Data Pricing and Reference Data.
Fundamental data provided by Morningstar, Inc..
SEC Filings data provided by Edgar Online Inc..
Earnings data provided by FactSet CallStreet, LLC.