Problem Found With Potential ADHD Patch
Notwithstanding the ongoing debate as to whether ADHD drugs are overprescribed because bored docs and overwhelmed teachers are overdiagnosing the disorder in children, it seems as the FDA once in a while actually serves the public purpose for which it was intended.
A patch developed to treat attention deficit hyperactivity disorder in children received a negative review from a Food and Drug Administration scientist, who concluded the drug cannot be safely marketed.
The patch uses methylphenidate, the same drug that is in Ritalin. But FDA reviewer Dr. Robert Levin found the patch produces troubling side effects too often to be considered safe. His findings were in briefing documents released by the agency on Thursday in advance of a public meeting on the drug.
The reviewer’s findings are not the final word. An independent panel of experts convened by the FDA is expected to consider on Friday whether the patch is effective and safe. The FDA has the final call on whether the patch can be made available, but the agency often follows the advice of its panels.
If only more drugs received this kind of critical review, I’d think some pharmaceutical companies wouldn’t be facing so many lawsuits these days.
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5 Comments to
“Problem Found With Potential ADHD Patch”
Can you identify the study or survey that justifies your comment that “bored doctors “prescribe add drugs. I suspect the are none.This type of gratuitus insult weaknens you arguments,even when they are correct.
I think you misread the comment. I said bored docs and overwhelmed teachers are overdiagnosing the disorder in children, not that they’re prescribing drugs because they are bored. ADHD is a specific disorder that requires meeting certain criteria of symptoms in 2 or more environments. Time and time again, I see well-meaning professionals ignore this component of the diagnosis, or stretch its meaning (so as to be meaningless). Additionally, there are also well-validated psychometric assessments for ADHD now. Unfortunately, they are rarely administered (because it requires an additional referral, additional time, additional work).
If you don’t think there’s overdiagnosing of ADHD going on today, I wonder at that…
The patch has been shown to reduce ADHD symptoms about as well as other oral treatments. But the FDA rejected the patch in 2003 because concerns over insomnia, tics, weight loss, and other side effects outweighed its benefits.
Noven Pharmaceuticals and Shire Pharmaceuticals, which are seeking to jointly market the patch, told FDA advisors that a new form delivering medication for nine hours is safer than the previous 12-hour form.
Agency safety officials initially took a dim view of the newer patch, expressing concern that the same side effects seen in the older patch were still an issue. Safety reviewer Robert Levin, MD, wrote in a brief presented Friday that the FDA should declare Daytrana “not-approvable.”
But Levin told committee members at the hearing that he had “reconsidered” his review and now recommended clearing the patch for marketing because most of the initially troubling side effects are similar to those commonly seen with other ADHD drugs.
“It’s clear that almost all of these, if not all … are consistent with those labeled in other methylphenidate products,” he said. “I think it’s … a reasonably safe treatment in this population,” Levin added.
I too am facing an uphill battle with my ex-wife over the use of DT and her obvlivion of the side effects. My Son’s entire personality is ‘wiped clean’ when he’s on this med, especially toward the end of the day. He has lost a tremendous amount of weight, though she agreed to take him off the med over the summer. I am a complete opponent of ANY and ALL medications, but I guess it all boils down to whatever is the path of least resistance with respect to schools, physicians, and the big pharmaceuticals.
Furthermore, with an ever increasing (i.e. HUGE) number of adults on mood ‘enhancers’ and anti-depressants, who the hell knows anymore how people are truly supposed to act and judge what is ’socially acceptable’ behavior? I’d be willing to bet that a large percentage of teachers and parents alike are on meds themselves so essentially what’s at hand is that we’re a nation of zombies…way to go FDA and big pharma companies! No wonder our nation can no longer compete with the world, but hey, as long as you’ve got a subdued population that will just stay inside the box and never question authority, then pat yourselves on the back!
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Last reviewed: By John M. Grohol, Psy.D. on 2 Dec 2005
