Navigation Links
FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults
Date:1/7/2009

chotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported with olanzapine. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

Also, as with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Other potentially serious adverse events include seizures, elevated prolactin levels, elevated liver enzymes, cognitive and motor impairment, body temperature elevation, and trouble swallowing.

The most common treatment-emergent adverse event associated with oral Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.

Full prescribing information, including a boxed warning, is available at www.zyprexa.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
2. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
3. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
6. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... , Aug. 3, 2015 Biosensors ... BIG SP; Reuters: BIOS.SI; SGX: B20), a developer, ... announced financial results for its first fiscal quarter ... Quarter Highlights and Recent Developments: ... in improving its cost structure, driven by lower ...
(Date:8/3/2015)... 3, 2015  Array BioPharma Inc. (NASDAQ: ... quarter and full year of its fiscal year ... Chief Executive Officer of Array, noted, "Binimetinib and encorafenib, ... on track for regulatory submissions in 2016. Additional ... and BRAF-mutant colorectal cancer further validate the value ...
(Date:8/3/2015)... FLORHAM PARK, N.J. , Aug. 3, 2015 ... its primary and secondary endpoints in a phase III ... (OIC) in adult patients with chronic non-cancer pain. Naldemedine ... (PAMORA). This is the third Phase III trial in ... Study results showed that a 0.2 mg ...
Breaking Medicine Technology:Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 2Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 3Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 4Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 5Biosensors Reports Financial Results for the First Quarter of Fiscal Year 2016 6Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 2Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 3Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 4Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 5Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 6Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 7Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 8Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 9Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 10Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 11Array BioPharma Reports Financial Results For The Fourth Quarter And Full Year Of Fiscal 2015 12Naldemedine Meets Primary Endpoint In Phase 3 Study For The Treatment Of Opioid-Induced Constipation 2Naldemedine Meets Primary Endpoint In Phase 3 Study For The Treatment Of Opioid-Induced Constipation 3Naldemedine Meets Primary Endpoint In Phase 3 Study For The Treatment Of Opioid-Induced Constipation 4
... 2011 Graymark Healthcare Inc. (Nasdaq: ... diagnostic sleep services and an innovator in comprehensive care for ... patients in the fourth quarter of 2010, with a 16% ... shipments, as compared to fourth quarter of 2009. ...
... Isis Pharmaceuticals, Inc. (Nasdaq: ISIS ) ... Isis, Development PipelineWhen: , Thursday, January 06, 2011 ... , www.isispharm.comHow: , Live on the Internet.  Simply ... , Kristina LemonidisDirector, Investor Relations(760) 603-2490Amy Blackley, Ph.D.Assistant ...
Cached Medicine Technology:Graymark Healthcare's Sleep Apnea Therapy Program Services Record Number of Patients in Q4 2010 2Graymark Healthcare's Sleep Apnea Therapy Program Services Record Number of Patients in Q4 2010 3
(Date:8/3/2015)... ... , ... The art of preparing and cooking food comes naturally to some. ... age, Nasreen Zereshki was extremely eager to cook Persian cuisine. Now that she is ... Persian Kitchen with the world. , Since Americans tend to be undereducated about Persian ...
(Date:8/3/2015)... Alachua, FL (PRWEB) , ... August 03, 2015 , ... ... peripheral nerve injuries, is scheduled to present at the Wedbush Healthcare Conference on Wednesday, ... , A live webcast and subsequent archived replay of the Company’s presentation may be ...
(Date:8/3/2015)... ... 03, 2015 , ... It’s 25 miles from remote Medicine ... and among its least visited State Parks. The volcanic area beneath Medicine Lake ... at Ahjumawi Lava Springs, part of the Fall River Springs complex. * According ...
(Date:8/3/2015)... ... 03, 2015 , ... A July 9 article from USA Today ... according to the American Dental Association. According to a study by the American Dental ... million in a single year to 2.2 million a year. Dentists and ADA officials ...
(Date:8/3/2015)... ... 03, 2015 , ... From 2006-2017 the number of dental ... market research compiled for the National Association of Dental Laboratories ( NADL ) ... of Labor Statistics. As the number of dental laboratories decreases, dentists will have ...
Breaking Medicine News(10 mins):Health News:Persian Cuisine: Colorful and Extremely Healthy 2Health News:AxoGen, Inc. to Present at the Wedbush Healthcare Conference 2Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 2Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 3Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 4Health News:Los Angeles Periodontists Comment on Rising Dental Emergency Room Trips 2Health News:Los Angeles Periodontists Comment on Rising Dental Emergency Room Trips 3Health News:Dental Association Announces Impending Reduction of Dental Laboratories Could Impact Dentists 2Health News:Dental Association Announces Impending Reduction of Dental Laboratories Could Impact Dentists 3
... 21 In this unstable economic,environment characterized by ... competition in the,bio/pharma marketplace, retaining your most-valued customers ... posts - from web interactions,and early warning systems ... toward,defining the superior customer experience. , ...
... invited to participate with U.S. Secretary of Health, Michael Leavitt, in ... ... Salt Lake City (Vocus) November 20, 2008 -- MediConnect CEO, ... Health, Michael Leavitt, in the 2008 National Summit on Personalized Health ...
... and Extremely Intuitive to Navigate, Making Shopping for Safety Products Easier ... ... 2008 -- Conney Safety Products is proud to announce that their ... state-of-the-art technology. The new website is faster, more efficient and features ...
... D. and Catherine T. MacArthur Foundation is creating a new ... and opportunities posed by our aging society. In the ... an aging society, one feature of which is that those ... Although the nation will become increasingly gray in subsequent decades, ...
... returned positive results in review of national program , , ... detects 40 percent of cancers and should be carefully ... researchers. , They studied 106,000 people, aged 60 to ... program was in identifying unrecognized disease. Half the people ...
... (NMQF) today applauded the American Medical Association,s recent decision to ... physician and patient advocates to join the Forum in encouraging ... , "Physicians and lawyers -- even politicians -- ... Chief Executive Officer of the Forum. "It,s long past time ...
Cached Medicine News:Health News:Creating Brand Advocates by Delivering the Superior Total Customer Experience 2Health News:MediConnect Participates in 2008 National Health Summit 2Health News:Conney Safety Products, Leader in Safety Equipment and Supplies, Launches New Website 2Health News:New MacArthur network to examine impact of aging society 2Health News:Colorectal Cancer Screens Detect Unrecognized Disease 2Health News:National Minority Quality Forum Applauds AMA's Health Insurer Code of Conduct 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: