ADHD Drugs cause Heart Attack, Stroke & Psychotic-Suicidal Behaviour

I hate to see this.
All 3 of my neighbor's grandkids are taking Strattera.


The medications affected by the action include Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA and Strattera.

Areas of concern: cardiovascular adverse events in patients with underlying heart problems or defects, along with reports of stroke and heart attack in adults with certain risk factors.

The second concern involves psychiatric events, primarily psychotic symptoms such as hallucinations or delusional thinking or the emergence of manic symptoms, even in patients who have no history of psychiatric problems.



The FDA has directed the manufacturers of all drug products approved for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) to alert patients of possible cardiovascular risks and adverse psychiatric symptoms associated with the medicines.

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ADHD Drugs Need Better Warnings on Heart, Psychiatric Risks: FDA
February 21, 2007

(HealthDay News) -- U.S. health officials on Wednesday told manufacturers of all drugs used to treat attention-deficit hyperactivity disorder that they must develop patient medication guides warning of possible cardiovascular and psychiatric risks.

"We issued letters earlier today to manufacturers of all the ADHD products asking them to implement medication guides to alert patients and their families to certain risks that may be associated with these drugs when taken at usual doses," said Dr. Tom Laughren, director of the psychiatry products division at the Center for Drug Evaluation and Research with the U.S. Food and Drug Administration.

According to the FDA, ADHD affects 3 percent to 7 percent of school-aged children and about 4 percent of adults. An estimated 2.5 million U.S. children and 1.5 million adults now take medications for the treatment of ADHD -- a field that has seen its share of controversy.

Spiraling growth in use of these medicines -- the number of adults aged 20 to 44 using ADHD drugs surged more than 139 percent from 2000 to 2005 -- has already prompted safety questions.

One drug, Strattera, is now required to carry a black box warning that it might prompt suicidal thoughts in children.

Last year, Health Canada briefly pulled another drug, Adderall, from the market because of reported cardiac risks. And in the United States, Adderall XR carries a warning that patients with heart conditions should not use the drug.

Last year, an FDA pediatric advisory panel recommended against putting black box warnings about psychiatric and cardiac risks on ADHD drugs. Instead, the panel recommended that the medications use simpler language and include more information on the label

A month before that, however, another FDA advisory committee, the Drug Safety and Risk Management Committee, reached the opposite conclusion when it called for a black box warning on ADHD drugs because of possible cardiac risks.

The FDA essentially followed the advice of the pediatrics committee, rejecting the black box warnings. Instead, new warning language was incorporated into the labels by last fall.

"It has taken us longer to develop language for the medication guides, and we expect that the companies will quickly implement the new language," Laughren said. In fact, companies have 30 days to comply with the directive.

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The patient medication guides address two areas of concern.

The first is cardiovascular adverse events in patients with underlying heart problems or defects, along with reports of stroke and heart attack in adults with certain risk factors.

The second area of concern involves psychiatric events, primarily psychotic symptoms such as hallucinations or delusional thinking or the emergence of manic symptoms, even in patients who have no history of psychiatric problems.

The medications affected by the action include Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA and Strattera.


"In no way do we consider this a general prohibition against using these drugs," Laughren said. "We view the drugs as quite safe and effective, and in no way are we trying to inhibit appropriate prescribing."

View drafts of the patient medication guides at the U.S. Food and Drug Administration:
[link to www.fda.gov]

SOURCES: Feb. 21, 2007, teleconference with Tom Laughren, M.D., director, division of psychiatry products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Steven Lipshultz, M.D., professor and chairman, department of pediatrics and dean of child health, University of Miami Miller School of Medicine

[link to www.washingtonpost.com]