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     FDA to ADHD Drug Makers: Warn Patients
     Ivanhoe Newswire

     By Vivian Richardson, Ivanhoe Health Correspondent

     ORLANDO, Fla. (Ivanhoe Newswire) -- Patients need to know about the
possible risks associated with medications for attention deficit
hyperactivity disorder (ADHD), Food and Drug Administration officials
announced this week.

     ADHD medications, like Adderall and Ritalin, have been linked in rare
cases to cardiovascular risks and some psychiatric symptoms, like
hallucinations and paranoia. The FDA is requiring ADHD drug manufacturers to
prepare Patient Medication Guides to be handed out when the medications are
given to patients. The FDA-approved guides will contain information about
the risks and what patients can do to prevent serious problems from
happening.

     Massachusetts psychiatrist Dennis Rosen, M.D., told Ivanhoe he agrees
with the FDA's recent decision. "What it speaks to is the need for all
physicians to receive information from the pharmaceutical industry and to
provide information to their patients to educate them," he said.

     Dr. Rosen said stronger actions, like the "black box" warning an FDA
panel suggested about a year ago, could undermine the benefits ADHD
medications give patients.

     "The relative benefits of these medications versus the risks are so
dramatically different that a black box warning would sufficiently imbue Tom
Cruise and his cohorts the ammunition to interfere and undermine the sense
of trust that patients are beginning to develop with physicians about being
educated regarding these factors," Dr. Rosen said.

     After a close vote last year, an FDA advisory panel voted recommend a
"black box" warning, the strongest warning, after learning of the deaths of
25 people, including 19 children, who had taken ADHD medications. There were
also reports of stroke and heart attack in adults with cardiovascular risk
factors. Additionally, several studies suggested patients on the medications
are more likely to experience adverse psychiatric effects than patients
taking placebo, though the risk is just one in 1,000.

     "In the majority of the cases there was some underlying cardiovascular
risk, not all of them, but a majority of them," said Dr. Rosen. He strongly
urges any physician considering prescribing an ADHD medication to check with
the patient's primary care provider and rule out any pre-existing heart
conditions.

     ADHD affect 3 percent to 7 percent of school-aged children and 4
percent of adults. Physicians have written more than 190 million
prescriptions for ADHD drugs since 1992, according to testimony given to the
FDA last year.

     To see draft versions of the FDA Patient Medication Guides, click on:
http://www.fda.gov/cder/drug/infopage/ADHD/default.htm.

     SOURCE: Ivanhoe interview with Dennis Rosen, M.D.

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