December 7, 2009

FDA Approves Zyprexa for Bipolar Adolescents

The U.S. Food and Drug Administration (FDA) has approved Zyprexa (olanzapine) for treatment of schizophrenia and manic/mixed episodes associated with Bipolar I disorder in adolescents aged 13-17 years. This approval, announced on Dec. 4, comes with plenty of warnings for would be users of the drug.

The updated Zyprexa label states that clinicians should take into consideration the increased potential for weight gain and hyperlipidemia in adolescents compared to adults and the potential for long-term risks, which in many cases, may lead them to consider prescribing other drugs first in adolescents. For additional reference review our Oct. 28 blog which discusses a widely reviewed Journal of the American Medical Association study which found that teens are more prone to weight gain when taking atypical antipsychotic drugs than adults.

An FDA Psychopharmacologic Drug Advisory Committee (PDAC) met in June and discussed the difficulties of diagnosing and treating these conditions in adolescents. The Zyprexa label provides additional guidance to physicians that medication therapy for pediatric schizophrenia or bipolar I disorder should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks associated with medication treatment. The FDA said it will examine the weight-gain side effect in children at a hearing next week.

With Friday's announcement Zprexa joins Seroquel (See Dec 6 blog), Abilify and Risperdal as atypical antipsychotics that are now FDA approved for children and/or adolescents.

Zyprexa is manufactured by Eli Lilly and was their top-selling medication in 2008, with sales of $4.7 billion

Resources
Percocet Addiction

Posted by Michael Lane at 11:14 AM | Comments (39)

December 6, 2009

FDA Approves Seroquel for Bipolar Children and Adolescents

The U.S. Food and Drug Administration (FDA) announced Friday that Seroquel (quetiapine fumarate) has been approved for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy (single-drug therapy) and as an adjunct to Lithium or Depakote (valproic acid). The FDA also approved Seroquel for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy.

"Bipolar mania and schizophrenia in children and adolescents, while rare, are serious disorders and it is important to have treatments approved for use in this patient population," said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, the firm that manufactures Seroquel, part of class of drugs known as atypical antipsychotics. "These new indications for Seroquel provide another FDA-approved option for treating pediatric patients suffering from these severe mental illnesses."

Our readers may want to review recent posts under "Childhood Bipolar Disorder" including a recent blog (Oct 28) regarding potential side effects such as dramatic short-term weight gain associated with well-known atypical antipsychotics including Seroquel.

The FDA also approved once-daily Seroquel XR (Extended Release) Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder on Friday. Seroquel XR is reportedly the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy, according to AstraZeneca.

Source: AstraZeneca news releases

Posted by Michael Lane at 9:31 PM | Comments (10)

December 1, 2009

Ticket to Work Schedule Update

During the NAMI 2009 conference we met with representatives of the Social Security Adminstration's Ticket to Work program which provides financial incentives for small businesses to employ people with disabilities. This program has been retooled recently with the objective of making it easier and more lucrative for businesses to hire people who suffer from bipolar disorder, depression and other Mental Illnesses.

This program has just released a schedule of events in 17 states during December and January. For more information or to sign up for one of these program you can access Ticket to Work.

If you own a small business or are in a situation where you might qualify to work in a small business, you might review this program. The program administrators are actively working to add new businesses and get more people with disabilities back to work.

See our Oct 29 blog to access background information on this program.

Posted by Michael Lane at 8:41 PM | Comments (8)