Navigation Links
FDA Approves First Anti-Psychotic for Kids

Risperdal had been used off-label to treat children with schizophrenia, bipolar disorder

WEDNESDAY, Aug. 22 (HealthDay News) -- The powerful anti-psychotic drug Risperdal was approved by the U.S. and Food Administration on Wednesday for use in children and adolescents who have schizophrenia or bipolar disorder.

Until this point, the agency hadn't approved any drug for the treatment of adolescent schizophrenia. For bipolar disorder, only lithium is approved for use in adolescents aged 12 and older.

"The FDA has approved Risperdal for treating schizophrenia in adolescents 13 to 17 and for the short-term [three-week] treatment of bipolar I disorder in children and adolescents 10 to 17," Dr. Thomas Laughren, director of the Division of Psychiatry Products at the agency's Center for Drug Evaluation and Research, said during a midday teleconference.

One expert thinks the move is warranted.

"This is a drug that has real value," said Dr. Charles Goodstein, a clinical professor of psychiatry at New York University Medical School. "But one has to exercise a degree of caution when using what amount to be heavy-duty medications in young children and adolescents."

Goodstein noted that diagnosing children with these conditions is difficult, and that can lead to misdiagnosis and the prescribing of inappropriate medications. "One has to very careful that this medication is not overused," he said.

"Bottom line, it's a valuable medication, one that can produce momentous changes in a person's functioning, but a medication that should be used with great care, because it does have side effects, and too often diagnoses are made more readily than they should be made," Goodstein said.

The agency first approved Risperdal (risperidone) in 1993 for treating schizophrenia in adults. It was approved subsequently for the short-term treatment of acute manic or mixed episodes of bipolar I disorder in adults and the treatment of irritability associated autism in children and adolescents aged 5 to 16, Laughren noted.

Risperdal brought in $2.3 billion in sales in 2005, according to the Associated Press.

Laughren said the medication belongs to a class of powerful drugs that do have side effects, but they are used to treat disabling conditions that fail to respond to other medications.

"Both of these disorders are commonly treated off-label in pediatric patients with Risperdal and other drugs that are approved for treating these conditions in adults," Laughren said.

The FDA based its approval for using the drug with schizophrenic adolescents on the results of two short-term trials. Patients taking the drug had fewer symptoms, including fewer hallucinations and less delusional thinking.

In terms of bipolar disorder, the agency relied on the outcome of a three-week trial among children and adolescents with bipolar I disorder. In this trial, patients taking Risperdal had fewer symptoms, including a reduction in elevated mood and hyperactivity, the agency noted.

Common side effects of Risperdal include drowsiness, fatigue, increased appetite, anxiety, nausea, dizziness, dry mouth, tremor and rash. "This adverse event profile is similar to what we have seen in adults who are treated with these medications," Laughren said.

However, Laughren noted Risperdal might also affect growth and development in adolescents, so the FDA has asked the drug's maker, Janssen, L.P., of Titusville, N.J., to begin a study to look a those potential problems.

Schizophrenia is a disabling psychiatric disorder with symptoms that can include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, causes shifts in mood, energy and ability to function.

More information

For more information on Risperdal, visit the U.S. Food and Drug Administration.

SOURCES: Aug. 22, 2007, teleconference with Thomas Laughren, M.D., director, Division of Psychiatry Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Charles Goodstein, M.D., clinical professor, psychiatry, New York University Medical School, New York City, and psychiatrist, Tenafly, N.J.

Copyright©2007 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Approves Contraceptive Ring
2. FDA approves new device to treat womens bleeding disorder
3. FDA Approves New HIV Drug, Viread
4. FDA Approves Birth Control Skin Patch
5. FDA approves surgical gel
6. FDA Approves New Arthritis Drug, Bextra
7. FDA Approves Elidel Cream for Eczema
8. FDA approves drug for rare liver disease
9. FDA approves first pocket-sized EKG machine
10. FDA Approves New Anti-Clotting Drug
11. FDA Approves New surgery Treatment for Farsightedness
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... Bcureful—a non-profit organization devoted to ... raising public awareness of the disorder while helping to bring expert medical care ... to bolster progress at the Tuberous Sclerosis Complex Center at Ann & Robert ...
(Date:11/24/2015)... , ... November 24, 2015 , ... ... to offer their patients the many benefits of the revolutionary BIOLASE WaterLase iPlus ... cutting and scraping tools traditionally used by a dentist in Gettysburg, PA ...
(Date:11/24/2015)... ... 24, 2015 , ... ThirdLove, the fast-growing bra company that ... offering 40% off select bras and underwear styles, now through Saturday, November 28th. ... technology and the latest fashion, quickly becoming the next generation of luxury bras. ...
(Date:11/24/2015)... ... 24, 2015 , ... Preparing for the LDT Regulation:, CLIA Won’t Satisfy the ... , FDA has long asserted that design and manufacture of Laboratory Developed Tests ... do not meet the device regulations. , Come up short in an inspection and ...
(Date:11/24/2015)... ... November 24, 2015 , ... United Benefit Advisors (UBA), ... & Company as its newest Partner Firm. Based in Jefferson City, Missouri, their ... trusted advisor regardless of whether that client is a business, a family, or ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , November 25, 2015 ... Investors"), pursuant to which BioLight and the New Investors ... Ltd. subsidiary ("IOPtima") via a private placement. The financing ... its innovative IOPtimate™ system used in the treatment of ... pathway process for the IOPtimate™ system with the U.S. ...
(Date:11/25/2015)... 2015 Developmental, commercial, and regulatory/legal ... profitability of pharmaceutical products, says GBI Research ... regulatory/legal strategies all play a key role in boosting ... . --> Developmental, commercial, ... in boosting the profitability of pharmaceutical products, says ...
(Date:11/25/2015)... Research and Markets ( ) has ... Global Forecast to 2020" report to their offering. ... 37.21% of the total market share in 2014. The ... is projected to growth at the highest CAGR between ... to the fast growing water, industrial gas treatment, pharmaceutical, ...
Breaking Medicine Technology: