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The
Manhattan Adult ADD Support Group
We Offer Support
& Information To Adults
In NYC
And The Surrounding Communities
With ADD/ADHD
We Are Not
"Lazy, Crazy, Or Stupid" |
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ADD IN THE NEWS |
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ADHD Drug Makers to Warn of Side
Effects
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February 21, 2007 |
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WASHINGTON (AP) - Drugs prescribed
to treat attention deficit hyperactivity disorder will include
guides to alert patients and parents of the risks of mental and
heart problems, including sudden death. |
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The Food and Drug Administration
said Wednesday that it directed the manufacturers of Ritalin,
Adderall, Strattera and all other ADHD drugs to develop the guides.
In May 2006, the agency told manufacturers to revise the labels of
the drugs to reflect concerns about the cardiovascular and
psychiatric problems. |
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Draft versions of the guides posted
on the FDA Web site include discussion of reports of increased blood
pressure and heart rate in ADHD patients, as well as cases of sudden
death in some who have heart problems and heart defects. In adult
patients, the reported problems also include stroke and heart
attack. |
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The alerts also cover psychiatric
problems, such as hearing voices, unfounded suspicions and manic
behavior, of which there is a slightly increased risk in patients
who take the drugs, the FDA said. The guides also tell patients and
their parents of precautions they can take to guard against the
risks. |
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Wednesday's announcement came
roughly a year after two panels of FDA advisers recommended that the
drugs include such patient medication guides. The announcement
covers 15 drugs, including extended-release, patch and chewable
versions of some of them. |
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Ritalin is manufactured by Novartis
Pharmaceuticals Corp. and in generic form by other companies;
Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli
Lilly & Co. |
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ADHD affects an estimated 3 percent
to seven percent of school-age children and four percent of adults,
the FDA said. |
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On the Net: |
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Food and Drug Administration ADHD
drug information:
http://www.fda.gov/cder/drug/infopage/ADHD/default.htm
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