Guest guest Posted March 19, 2006 Report Share Posted March 19, 2006 SSRI-Research@ Sat, 18 Mar 2006 17:34:10 -0500 [sSRI-Research] ASHP - ADHD Drugs Lack Psychosis Warnings, FDA Says http://www.ashp.org/news/ShowArticle.cfm?cfid=11587059 & CFToken=10876124 & id=14536 ADHD Drugs Lack Psychosis Warnings, FDA Says BETHESDA, MD, 16 March 2006 --- Signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors at usual dosages of any of the drugs approved in the United States to treat attention-deficit/hyperactivity disorder (ADHD), according to the Food and Drug Administration (FDA). * *But current approved labeling for ADHD medications lack information about the risks of drug-induced signs or symptoms of psychosis or mania, drug safety reviewers said in a document <http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4210b_11_01_AdverseEvents.\ pdf> posted on FDA's Web site this week.* *The labeling for these drugs, the reviewers added, does not clearly state the importance of stopping drug therapy in any patient who has hallucinations or other signs or symptoms of psychosis or mania during drug treatment of ADHD.* * " We recommend that these issues be addressed, " the reviewers said.* *Regulators issued the review document this week in preparation for the March 22 meeting of FDA's Pediatric Advisory Committee, which is expected to discuss how best to communicate risk information about ADHD medications to prescribers and parents.* *The panel will also discuss adverse-event reports received during the first year of marketing of four drugs granted pediatric exclusivity under the Best Pharmaceuticals for Children Act.* *The Psychopharmacologic Drugs Advisory Committee is scheduled to meet the next day to discuss the sleep disorder drug modafinil, which is under review for marketing approval to treat ADHD.* *The Drug Safety and Risk Management Advisory Committee stunned regulators on Feb. 9 <http://www.ashp.org/news/ShowArticle.cfm?cfid=11587059 & CFToken=10876124 & id=1413\ 6> when the panel voted 8--7 to add a black-box warning to the labeling of stimulants used to treat ADHD to alert prescribers about cardiovascular risks associated with use of the drugs.* *At that meeting, regulators said that the agency had received reports of more than 20 deaths associated with use of ADHD drugs.* *In the document issued this week, FDA said that its ADHD psychiatric review team analyzed postmarketing reports of psychiatric adverse events associated with ADHD medication use received since January 2000 from drug sponsors and identified from the agency's adverse event reporting system (AERS).* *FDA received 18 reports from Shire of suicidal thoughts or behavior, known as suicidality, associated with the use of amphetamine salts, or Adderall. The company also reported 84 reports of psychosis or mania and 83 reports of aggression or violent behavior.* *FDA's review team identified 77 reports from AERS of psychosis or mania associated with amphetamine or dextroamphetamine use.* *Shire reported 33 occurrences of suicidality associated with use of its extended-release form of amphetamine salts, marketed as Adderall XR. The company also reported 92 occurrences of psychosis or mania and 95 reports of aggression.* *McNeil, which markets methylphenidate under the brand name Concerta, reported 121 occurrences of suicidality. The company also reported 160 cases of psychosis or mania and 219 reports of aggression.* *Novartis, which markets methylphenidate as Ritalin, reported 67 cases of suicidality. The company, which also markets dexmethylphenidate as Focalin, reported a combined 130 occurrences of psychosis or mania for the two drugs. However, FDA noted, because of the relatively limited use of dexmethylphenidate, those figures represent very few reports for that drug.* *FDA reviewers identified 148 reports from AERS of psychosis or mania associated with methylphenidate.* *The largest number of reports of suicidality associated with the use of an ADHD drug came from Eli Lilly and Co., which markets atomoxetine, or Strattera, a selective norepinephrine-reuptake inhibitor.* *The company reported 399 cases of suicidality associated with atomoxetine use.* *Eli Lilly last fall added a black-box warning to atomoxetine's labeling to warn prescribers about an increased risk of suicidality in children and adolescent users of the drug.* *The company also reported 360 occurrences of psychosis or mania in patients using the drug and 992 reports of aggression or violent behavior. FDA reviewers identified 292 reports from AERS of psychosis associated with the drug's use.* *Although modafinil is not approved for ADHD use, Cephalon, which markets the drug as Provigil for sleep disorders, reported 18 cases of suicidality. The company also reported 94 cases of psychosis or mania and 22 occurrences of aggression. FDA reviewers identified 43 reports from AERS of psychosis or mania associated with the drug's use.* */---Donna Young/* * * Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.