Clear as a bell

In other interesting health/medicine (and Tom Cruise) news, there are semi-conflicting reports of an FDA announcement regardling labeling changes of amphetamines used to treat ADHD that didn't apear to be posted at the FDA's web-site (at least not yet).

According to a report at Health Day, the pediatric advisory panel was hesitant to recommend class-wide changes in the labeling for the medications until more data based on current data.

A release posted on the U.S. Food and Drug Administration's Web site noted that members of the Pediatric Advisory Committee, in a meeting Thursday, did not come across any new concerns about psychiatric side effects with Concerta and other methylphenidates, which include Ritalin and Metadate. Panel members also suggested that the FDA wait until more safety data have been collected on two other types of drugs used to treat ADHD -- methamphetamines such as Adderall and the non-stimulant Strattera.

The FDA should "delay the labeling change until they have a good sense of class effect," Acting Committee Chairman Robert Nelson, of The Children's Hospital of Philadelphia, told FDA officials during the committee meeting, which was convened by the agency.

"We heard there is no terrible signal," Office of Pediatric Therapeutics Director Dianne Murphy said in the release.

"None of what I have heard today about these medications has made me particularly concerned," committee member Thomas Newman, of the University of California-San Francisco, said in the release.

According to a report at DowJones, the panel suggested the agency should move forward with label changes. Regardless of which reporter understood the gist of the panel's comments, the agency is still considering label revisions to address potential psychiatric side effects to "try to make it clearer what the situation is with regard to certain adverse events." That is, if they're "able to articulate it with certainty."

Tag: health care; medicine;ADHD; FDA ; tom cruise

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