Psychiatric, cardiac risks to be examined, and labeling changes to be considered
By Amanda Gardner
HealthDay Reporter
WEDNESDAY, March 22 (HealthDay News) -- The safety of drugs used to treat attention-deficit hyperactivity disorder will be in the spotlight once more on Wednesday, when a federal panel will scrutinize the psychiatric and cardiac side effects that have surfaced with growing use of these medications.
At the end of its deliberations, the U.S. Food and Drug Administration's pediatric advisory committee will consider strengthening label warnings about the possible risks of psychosis, mania and cardiac problems posed by several different drugs that belong to several different classes of ADHD medication.
"These medications all have side effects, and the new alarm is just that they're trying to figure out whether the risk-benefit ratio is worth taking the risk," said Dr. Eugenio Rothe, an associate professor of psychiatry at the University of Miami School of Medicine.
Under consideration are all marketed drugs for ADHD, including amphetamines (Adderall XR), methylphenidates (Ritalin, Concerta and Metadate) and the non-stimulant Strattera, along with Sparlon, a narcolepsy drug that is being considered as a treatment for ADHD. A separate FDA advisory committee will consider a new drug application for Sparlon's use as an ADHD drug on Thursday.
Theoretically, any recommendation could eventually affect a large number of people: Some 2.5 million children and 1.5 adults now take ADHD medications. And some experts, including Dr. Lenard Adler, director of the Adult ADHD Program at New York University Medical Center and author of the forthcoming Scattered Minds: Help and Hope for Adults with ADHD, believe the condition is undertreated.
But even if more restrictive labeling is recommended, experts say prescribing practices in this country won't necessarily change.
"People who are trained and comfortable and have knowledge about treatment are not going to change practice," said Dr. Karen Ballaban-Gil, a professor of clinical neurology and clinical pediatrics at Albert Einstein College of Medicine and Montefiore Medical Center in New York City. "People who are less comfortable may be more reluctant."
On the positive side, labeling changes could spur better care of people who use various ADHD medications.
"We know that these drugs cause changes in blood pressure and pulse that are relatively minor," Adler said. "These are areas where physicians and patients need to be aware. It's appropriate for them to have blood pressure and pulse monitored."
Controversy in this area is nothing new. Spiraling growth in use of the medicines -- the number of adults aged 20 to 44 using ADHD medications surged more than 139 percent from 2000 to 2005 -- has raised new safety questions.
In February, a different FDA advisory panel recommended "black box" labeling for Ritalin and other stimulants used to treat ADHD because of potential cardiac risks. This is the strongest possible label warning for a prescription drug. The recommendation was unusual because the committee was originally charged only with discussing whether further studies were feasible and necessary.
Last July, the FDA pediatric advisory committee decided to delay any labeling decisions on ADHD medications until more safety data was available.
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 Adderall from the market because of reported cardiac risks. In the United States, Adderall XR carries a warning telling patients with heart conditions not to use the drug.
But there are also risks to not using the medications, one expert said.
"Nothing else has been shown to be as effective from an academic standpoint as stimulant medication [such as Ritalin]," Ballaban-Gil said. "Untreated ADHD puts children at risk, when they become young adults, for at-risk behavior, particularly substance abuse."
"There are substantial risks in not being treated," Adler added. "Adults with ADHD are twice as likely to be unemployed and divorced. They underperform on the job. They're more likely to smoke cigarettes and have substance-abuse issues."
For now, stimulants, with all their risks and benefits, are the "gold standard against which all other [ADHD] medications are compared," Ballaban-Gil said.
SOURCES: Lenard Adler, M.D., director, Adult ADHD Program, New York University Medical Center, associate professor, psychiatry and neurology, New York University School of Medicine, New York City and author, Scattered Minds: Help and Hope for Adults with ADHD; Karen Ballaban-Gil, M.D, professor, clinical neurology and clinical pediatrics, Albert Einstein College of Medicine and Montefiore Medical Center, New York City; Eugenio M. Rothe, M.D., director, child and adolescent psychiatry clinic, Jackson Memorial Hospital, and associate professor, psychiatry, University of Miami School of Medicine
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