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ASHP - ADHD Drugs Lack Psychosis Warnings, FDA Says

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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/*

 

*

*

 

 

 

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