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(PSYCHIATRIC TIMES) - Moving with decidedly unbureaucratic swiftness, an FDA advisory panel has reversed an earlier call by another committee for restrictive black box labeling on medications prescribed for children with attention deficit hyperactivity disorder (ADHD).

"Do parents need to worry about the risks? In a word, no," said Robert W. Nelson, MD, chair of the FDA's Pediatric Advisory Committee, at the end of the committee's March meeting at which it called for improved communications between the agency and physicians and parents.

"The important thing to remember is that this meeting was about children," he said. "The data for the efficacy of the medications was quite strong. We did feel that there is a need for the FDA to improve its communications. But, while there are some concerns, they did not rise to [the] level of a black box warning."

"The committee was not impressed with the level of cardiovascular risk to children," added Robert Temple, MD, director of the FDA's Office of Medical Policy.

Nelson's committee was responding to the action of the FDA's Drug Safety and Risk Management (DSaRM) Advisory Committee, which had voted in February to recommend adding a black box warning on labels for stimulants used in the treatment of ADHD.

The DSaRM recommendation, which was approved by an 8 to 7 vote with 1 abstention, came after the committee had reviewed evidence of cardiovascular events&

151;including reports of sudden death&

151;in patients taking the stimulants.

Its action in recommending the black box warning caught FDA officials by surprise and drew some criticism from adolescent and child psychiatrists who felt the panel was lumping concerns about children with those of adults.

Black box warnings represent the most extreme level of caution from the FDA. They are widely perceived to influence prescribing; a study of more than 320,000 prescriptions that was published in the Archives of Internal Medicine earlier this year reported that 99.3% were written in compliance with black box warnings.

According to the FDA, "black box warnings are designed to highlight special problems, particularly those that are serious, and to give health care professionals a clear understanding of a potential medical complication associated with a drug. Black box warnings provide physicians with important insights as to how to prescribe a drug that may be associated with serious side effects in a way that maximizes its benefits and minimizes its risks."

In addition, the panel voted 15 to 0 with one abstention to recommend that the FDA develop "MedGuides" (the descriptive pamphlets given out by pharmacists with prescription medications to make patients aware of potential side effects or concerns about a drug) to warn of potential cardiovascular risk from stimulant drugs used in the treatment of ADHD.

"The [DSaRM] committee was composed largely of people working with adults, said David Fassler, MD, clinical professor of psychiatry at the University of Vermont College of Medicine, who testified at the March hearing.

"They were more focused on adult treatment and didn't include input from clinicians who actually work with children and adolescents. I was surprised by their actions, since the agenda of the committee was to discuss appropriate research methodology to determine whether or not these medications posed a risk in terms of cardiac functioning. Instead, the committee decided to use the hearing to make a statement about its concerns related to the increased use of these medications in general."

Fassler, testifying as a trustee of the American Psychiatric Association (APA), noted that "For the period 1999 to 2003, there were 25 reports of patients who died and 54 reports of patients who experienced other cardiac complications. During this time, there were 78 million prescriptions for these medications . . . [M]ost patients can and do take these medications without significant difficulties or complications."

"However, any side effects need to be taken seriously, particularly when they involve even the slightest risk of sudden death. For this reason, I fully support the call for more research on both the safety and efficacy of medication used in the treatment of ADHD. I also support the call for updated labeling language and for the development of MedGuides and fact sheets specific to these medications. Physicians and patients need and deserve as much information as possible in order to make fully informed decisions about treatment options."

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