Panel to Debate ADHD Drugs: Psychosis and Mania Risks
Timothy Wilens, an associate professor of psychiatry at Harvard Medical School, says most doctors who prescribe ADHD drugs are already aware that they can trigger psychosis, a rare side effect. Now an advisory panel will discuss whether the Food and Drug Administration should ask makers of attention deficit/hyperactivity disorder drugs to add labelling information about the possible risk of psychosis or mania, especially in children.
Following a panel’s recent decision to recommend ‘black box’ warnings for common ADHD drugs (“Black Box Warnings for Ritalin and Other ADHD Drugs”), due to concerns about an increased risk of sudden death and serious cardiovascular problems, including heart attacks, a pediatrics advisory panel is now set to examine whether drugmakers should be required to warn of increased risks of mania and psychosis, particularly in children.
According to an article carried by APA’s PsycPort:
Since Jan. 1, 2000, the agency and drugmakers have received hundreds of reports of psychosis or mania behavior, particularly hallucinations, in patients with no known risk factors who took the usual dose of an ADHD medication, according to a March 3 memo by two psychiatric drug reviewers in the agency’s Office of Drug Safety.
From 2000 through 2005, use of ADHD drugs by children and adolescents in the USA rose 57%, and use in adults doubled, data from Medco Health Solutions show.
Current approved labeling for ADHD drugs does not clearly address the risk of drug-induced psychosis or mania symptoms in such patients, medical epidemiologist Kate Gelperin and safety evaluator Kate Phelan write. And, they say, the labeling does not clearly state that patients should stop taking the drugs if such symptoms develop. “We recommend that these issues be addressed,” they write.
A “substantial proportion” of reported cases were in children age 10 or younger in whom hallucinations are uncommon, the FDA reviewers write. “The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking, and deserves further evaluation.” In many patients, such symptoms went away after they stopped taking the drug, the reviewers write.
It seems the longer such drugs are in use, and the more we learn about their longer-term effects, the more complicated the risk/benefit analysis becomes.
Also see our recent article on the methylphenidate transdermal patch for ADHD, to be marketed soon under the brand name Daytrana: “ADHD Patch to be Sold as Daytrana”.
Other articles by Dr Greg Mulhauser, Managing Editor
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19th September 2007
My 14 yr old son Josh has been on ADHD med for years without any known side effects until a Dr in Roch Mi changed the Celexa to Paxil. He was doing well for about 2 mos. he was also on Adderal. Last week he started getting psycotic, racing thoughts did’t sleep thru for a few days; anyway he’s been in a hopital all week . The psyciatrist says being on the Paxil w/ the adderal caused him to become bi-polar. I am so upset with the Dr in Roch knowing that that was a possability. My other son was diagnosed w/ PDD about 6yrs ago and he has been on Adderal. Iwish there was something else Icould do. signed 1 distressed mom