Navigation Links
FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
Date:6/10/2009

rolled trial to assess the efficacy and safety of Zyprexa in 72 adolescents (aged 13-17 years old) with schizophrenia; and a three-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of Zyprexa in 107 adolescents (aged 13-17 years) with acute manic or mixed episodes associated with bipolar I disorder.

In these studies, adolescents taking Zyprexa experienced significant improvements in their schizophrenia and bipolar symptoms on various efficacy measures. Symptoms of schizophrenia include acute episodes of delusions, hallucinations and long-term impairments such as diminished emotion, lack of interest and depressive signs and symptoms(1). Manic symptoms of bipolar I disorder include long periods of euphoria, restlessness, behaving impulsively and being easily distracted(2). A mixed bipolar state occurs when symptoms of depression and mania are experienced at the same time(3).

In addition to the two placebo-controlled studies, the Committee reviewed extensive Zyprexa safety data relevant to adolescents. Increased weight, appetite, and sedation were among the most common adverse events observed in adolescents. Weight gain was greatest in adolescents who were overweight or obese when they began treatment. Significant weight gain was also observed in patients who were of normal weight at baseline.

Although no clinical trials comparing adolescents to adults were conducted, data from the adolescent trials were compared to those from the adult trials. The types of adverse events observed in adolescents treated with Zyprexa were similar to those seen in adults. The incidence and magnitude of changes in weight, prolactin, triglyceride, cholesterol and hepatic enzyme levels were greater in adolescents than adults. Sedation was also more common in adolescents than adults.

"Because weight gain and some of the metabolic changes are more likely to occur and to be more prono
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Top Medical Research Centers Form Velos Advisory Group for Service-Oriented Architecture
2. Advanced Life Sciences Announces Outcome of FDAs Anti-Infective Drugs Advisory Committee Review of Restanza(TM) (cethromycin)
3. FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmabs ARZERRA(TM) (ofatumumab)
4. FDA Advisory Panel Recommends Approval of the SEDASYS(R) System
5. Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes
6. FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
7. Savient Announces FDAs Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
8. AstraZeneca Responds to FDA Joint Advisory Committees Recommendation on SYMBICORT(R)
9. Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
10. New Jersey American Water Lifts Precautionary Boil Water Advisory For Middlesex, Somerset and Union Counties
11. Arpida Comments on FDAs Anti-infective Drugs Advisory Committee Outcome
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Texas , Jan. 15, 2014  Novation, the leading ... awarded several new IT value-added reseller (VAR) national contracts ... IT goods and services at lower costs. These include ... services such as initiative assistance and ongoing IT consulting ...
(Date:1/15/2014)... 2014 Shire plc (LSE: SHP, NASDAQ: ... Trading (OFT) approval condition to the announced tender offer for all ... As a result of the waiver, the transaction is no ... tender offer on January 24, 2014 following the currently scheduled expiration ...
(Date:1/15/2014)...  Manufacturers, suppliers and distributors of innovative medical-related products ... most important business assets, intellectual property (IP). ... Because of the highly-competitive nature of the Medical ... most litigious industry sectors of cases involving IP ...
Breaking Medicine Technology:New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3Intellectual Property Insurance for Medical-related Products and Services 2
... Valeant Pharmaceuticals International, Inc. (NYSE: VRX ) ... former senior vice president and corporate controller, has been ... effective immediately, replacing Peggy Mulligan, former chief financial officer, ... other interests.  The Company has initiated a search to ...
... (Nasdaq: STXS ) announced today that the Company ... which includes a $30 million revolving facility that matures on ... matures on December 31, 2013.  The new facility was led ... that was scheduled to mature in March 2011. ...
Cached Medicine Technology:Valeant Pharmaceuticals Appoints Philip W. Loberg as Interim CFO 2Valeant Pharmaceuticals Appoints Philip W. Loberg as Interim CFO 3Stereotaxis Completes $40 Million Credit Facility 2Stereotaxis Completes $40 Million Credit Facility 3
(Date:4/17/2014)... New Rochelle, NY, April 17, 2014U.S. military personnel ... "blast plus impact" concussive traumatic brain injury (TBI) ... were evacuated for other medical reasons. Differences in ... and depression 6-12 months after injury are reported ... , a peer-reviewed journal from Mary Ann Liebert, ...
(Date:4/17/2014)... as 10 million older Americans suffer from depression, often ... However, new research a project that followed the ... years found that Internet use among the elderly ... 30 percent. , "That,s a very strong effect," said ... information studies and media who led the project. "And ...
(Date:4/17/2014)... 2014-- Colic affects about one in five infants in ... visits during the first several months after birth. Research ... showing promise; however, the April 1, 2014 issue of ... reported on a study, "Probiotics and Infant Colic," concluding ... for infant colic did not reduce crying ...
(Date:4/17/2014)... University School of Medicine (BUSM) have discovered that ... an experimental model. The findings, reported in the ... , may lead to more effective treatments for ... of the leading causes of illness and death ... impact by limiting the productivity of workers and ...
(Date:4/17/2014)... team led by researchers at UC Davis has shown ... key role in cell division, also boosts the mitochondrial ... time the complex has been shown to perform both ... excellent target to control cellular energy production, potentially advancing ... online today in the journal Developmental Cell . ...
Breaking Medicine News(10 mins):Health News:Long-term effects of battle-related 'blast plus impact' concussive TBI in US military 2Health News:Internet use can help ward off depression among elderly 2Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2Health News:BUSM researchers find anti-seizure drug may reduce alcohol consumption 2Health News:Dual role: Key cell division proteins also power up mitochondria 2
... a competitive application process, Michele D. Kipke, PhD, Vice ... Hospital Los Angeles, was awarded a $420,000 grant which ... Autism Treatment Network (ATN) as an ATN Center of ... Speaks, which is North America,s largest autism science and ...
... hemorrhagic fever in humans, has no known cure or vaccine. ... scientists has uncovered a family of small molecules which appear ... inhibit its entry into human cells. The results are ... and are now online. Previous studies have shown ...
... discovered that cells lining the blood vessels secrete molecules ... invading other tissues, a finding that could lead to ... professor in the MIT-Harvard Division of Health Sciences and ... a patient,s tumor could shrink a tumor or prevent ...
... to research conducted at the Oregon National Primate Research Center ... that oral contraceptives cause weight gain appears to be false. ... appear in next month,s edition of the journal Human ... reveal that contraceptives and the possibility that they may cause ...
... WEDNESDAY, Jan. 19 (HealthDay News) -- Many U.S. transplant ... trying to develop new safeguards that would protect and ... one-third of transplant surgeons in the nation "overreacted" to ... contracted HIV after receiving organs from a single donor ...
... a gene that is mutated in one in three patients ... of a frequently mutated gene will provide new insights into ... critical in the continued effort to improve treatment for renal ... to be mutated in 88 cases out of 257 clear ...
Cached Medicine News:Health News:Children's Hospital Los Angeles joins Autism Treatment Network 2Health News:Small molecules may prevent ebola infection 2Health News:MIT scientists discover cancer-fighting role for cells 2Health News:MIT scientists discover cancer-fighting role for cells 3Health News:MIT scientists discover cancer-fighting role for cells 4Health News:Do birth control pills cause weight gain? New research says no 2Health News:Research provides new kidney cancer clues 2Health News:Research provides new kidney cancer clues 3
... Medical Professional Diagnostics is a leading provider ... and DFA test menu that includes kits ... as well as miscellaneous conjugates and components. ... a wide assortment of substrates and kit ...
... is a leading provider of immunofluorescence assays, ... menu that includes kits for autoimmune diseases, ... miscellaneous conjugates and components. Our Impact IFA ... of substrates and kit sizes to choose ...
... Diagnostics is a leading provider of immunofluorescence ... test menu that includes kits for autoimmune ... as miscellaneous conjugates and components. Our Impact ... assortment of substrates and kit sizes to ...
... Inverness Medical Professional Diagnostics is a leading ... IFA and DFA test menu that includes ... STDs as well as miscellaneous conjugates and ... you a wide assortment of substrates and ...
Medicine Products: