FDA: Concerned w/Psychiatric Risks with ADHD Drugs

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(1 hour ago)http://www.smartmoney.com/bn/ON/index.cfm?story=ON-20050628-000653-1405 FDA: Concerned With Psychiatric

Risks With ADHD DrugsJune 28, 2005By Jennifer Corbett DoorenOf DOW JONES NEWSWIRESWASHINGTON -(Dow Jones)- The Food and Drug Administration said it intends to make labeling changes for a certain class of drugs used to treat attention deficit hyperactivity disorder over concerns about psychiatric events associated with the drugs.The FDA said it would make labeling changes to Johnson & Johnson's (JNJ) Concerta and other methylphenidate products describing psychiatric events "such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior." The drugs are used to treat ADHD in adults and children. Other drugs in the category include Novartis AG's (NVS) Ritalin, which is also available as a generic.The FDA made the statement Tuesday as part of background material posted to its Web site ahead of a pediatric advisory committee meeting Wednesday and Thursday.An FDA spokeswoman declined to discuss the number of psychiatric adverse event reports it has received related to Concerta and similar drugs, saying the data would be presented to the pediatric panel on Thursday.A Johnson & Johnson spokeswoman wasn't immediately available to comment on Concerta. ADHD is a disorder in which people have attention, or inattention, problems that cause impairment in academic, work or social settings. People with ADHD are often hyperactive and impulsive. ADD is a similar disorder without the hyperactive behavior that is often associated with adults more than children.The panel of outside medical experts will be discussing adverse event reports in children for several drugs including Concerta. The reports are mandated by law for drugs approved specifically for use in children and are discussed before the pediatric panel on a periodic basis."In addition we believe it is critical to examine the other stimulant products approved for ADHD...to determine if they too are associated with these adverse events," the FDA said in its statement. The agency also said it would look at atomoxetine, a nonstimulant product sold under the brand name Strattera by Eli Lilly and Co. (LLY).The agency said it was currently reviewing adverse event reports for so-called amphetamine products like Shire Pharmaceuticals PLC's (SHPGY) Adderall as well as for Strattera and hoped to bring the review to the pediatric panel in early 2006.Meanwhile, the FDA is seeking the panel's advice on what information it should provide to the public about the ADHD drugs that are widely used in children while it's collecting information on the number of types of psychiatric events possibly associated with ADHD drugs along with possible cardiovascular risks.The agency is concerned with possible cardiovascular events in people using the drugs. Earlier this year Health Canada ordered Adderall off the market after reports of sudden death in 20 patients, including 12 reports of stroke.Last year the FDA required Shire to update Adderall's label in the U.S. to warn that it should not be used in children or adults with structural cardiac abnormalities.The FDA said it's too soon to tell if ADHD drugs really increase cardiovascular risk and that it was "pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD." Among the options, the FDA said, was long-term safety trials to look at cardiovascular risks.

 

 

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