LinkBlog
RSS Feeds
recommended links
- ABIL: Agoraphobics Building
Independant Lives - Agoraphobia and Panic
Disorder Foundation - Anxiety Disorders Association
of America - Anxiety Network Australia
- Anxiety-Panic.Com
- AnxietyZone
- Army Behavioral Health
- BrainPhysics - OCD
- Canadian Network for Mood
and Anxiety Treatments - Children of Hoarders
- Choices in Mental Health (UK)
- Dart Foundation: Gateway to PTSD
information - David Baldwin's
Trauma Information Pages - e-couch free personal self-help guide
- EMDR Institute, Inc.
- EMDR Network Japan
- Fear of Flying course (free)
- Healthy Minds
- Information for People with Anxiety Disorders
- Internet Guide to REBT, CBT
- Knowledge Center of the
Neuroscience Initiative - Living with a Brain Disorder
- Morita Therapy
- Mayo Clinic : Depression
- Mayo Clinic : GAD
- Mayo Clinic : OCD
- Mayo Clinic : Panic Attacks
- Mayo Clinic : PTSD
- Mayo Clinic : Social Anxiety
- Medicines.org.uk - Anxiety &
Depression guides - Mind-Your-Mind Canada
- National Center for PTSD
- National Institute of Mental
Health (NIMH) - No Such Thing As Crazy
- OCD Action, UK
- OCD Ireland
- Obsessive Compulsive Foundation
- Open Minds, Open Doors
- Out of the silence - site for young people with mental illness
- Paniccure.com
- Partners With PTSD
- Prescription Drug Information
- Psychiatric Service Dog Society
- PsychNews
- Rational Emotive Behavior
Therapy (REBT) - Sane Australia
- Shyness & Social Anxiety
Service of Australia - Social Phobia/Social Anxiety
Association - Social Anxiety Support board
- South African Depression &
Anxiety Group - Suicide Prevention Help
- tAPir - the Anxiety Panic
internet resource - The Panic Center (Free
CBT based programs) - The School of OCD
- UN-WHO Drug Trials Database
- U.S. Army Behavioral Health - PTSD
we support
"just don't smoke"
"Don't smoke, whatever you do, just don't smoke."
Yul Brynner
Yul Brynner
- Menthol cigarettes harder to quit
- Secondhand smoke in cars serious threat to kid's health
- Lung Cancer can run in families
- Starting smoking young increases addiction risk
- Exercise helps smokers quit
- Smoking doesn't slim girls;
stunts boys' growth - Cutting down not enough, smokers must quit
- 40 reasons why you should quit smoking
- Pregnant smokers 'prime' their kids to smoke
- Smoking related coronary artery disease quickly reversed if young smokers quit
- Not ready to quit? Try cutting back
- Half smoking again within year of lung cancer surgery
- Cutting back 'compensation' increases toxin load per cigarette
- Tobacco companies upped nicotine level 11% since 1998
- Workplace passive smoke increases lung cancer risk
- Hooked by genes: The DNA sequences cigarette companies love
- Smoking causes long lasting changes to brain's bio chemistry
- Nicotine receptor stimulant trebles the odds of stopping smoking
- Bupropion, nortriptyline double chances of quitting
- Nicotine's powerful role in reinforcing smoking
- Pregnant smokers raise child's risk of stroke, heart attack
- Smoking linked to pancreatic cancer
- Neurobiology of Smokers' Cravings
- 'Low cancer risk' cigarettes as deadly as regular kind
- Quitting reduces lung cancer death risk by 70%
- Fetal nicotine exposure linked to teen attention problems
- Outdoor second-hand smoke exposure can harm
- Response to day's first cigarette predicts ease of quitting
- 'Healthy' children of smoking parents aren't really so healthy
- Children of smokers have up to five times higher levels of a nicotine toxin
- Smoking increases risk of dementia
- Smoking kills even after quitting
- Antenatal second hand smoke exposure increases child's psychological problems
- Smoking could kill 1 billion this century: WHO
- Just 1 cigarette can lead to nicotine addiction
- Smokers less likely to survive early stage lung cancer
- Smokeless tobacco delivers carcinogens more efficiently than cigarettes!
- Smoking permanently turns on genes that increase lung cancer susceptibility
- Secondhand smoke a health hazard for pets too
- Hypnosis for smoking cessation sees strong results
- Smoking doesn't burn fat
- Smoking linked to sagging breasts
- No evidence waterpipes decrease smoking harm
- Tobacco smoke + alcohol damage hearts more than either alone
GlaxoSmithKline Agrees to Correct Paxil CR Manufacturing Deficiencies
posted Friday, 29 April 2005
FDA News Release
P05-21
April 28, 2005
GlaxoSmithKline Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies
The U.S. Food and Drug Administration (FDA) today announced that GlaxoSmithKline, Inc. (GSK), (through its U.S. subsidiaries SB Pharmco Puerto Rico, Inc., GlaxoSmithKline Puerto Rico Inc., and SmithKline Beecham Corporation), has signed a consent decree with FDA to correct manufacturing deficiencies at its Cidra, Puerto Rico facility.FDA is concerned that GSK's violation of manufacturing standards may have resulted in the production of drug products that could potentially pose risks to consumers.
The Decree requires GSK to post a penal bond of $650,000,000 contingent upon GSK's either successfully reconditioning drugs seized in March 2005 or destroying them and paying costs to the government.
"The consent decree shows that FDA is serious about enforcing the manufacturing standards essential for safe and effective prescription drugs," said John Taylor, FDA Associate Commissioner for Regulatory Affairs. "It should also reassure the American people that we are doing everything we can to preserve the integrity of the American drug supply."
FDA's last inspection found Paxil CR tablets, approved to treat depression and panic disorder, could split apart. This deficiency could cause patients to receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains an active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets, used to treat Type II diabetes, did not have an accurate dose of rosiglitazone, an active ingredient in this product.
The FDA urges patients who use these two drugs to continue taking their medication and to talk with their health care provider about possible alternative products until the manufacturing issues have been resolved.
Under the terms of this decree the company has agreed to take measures to ensure that its Cidra facility and the two drugs, Paxil CR and Avandamet, fully comply with current Good Manufacturing Practice ( cGMP) requirements and to ensure that ongoing shipments have the quality attributes they are required to possess. The decree also requires that all corrections and the firm's compliance with cGMP requirements be certified by a third-party expert. Additionally, FDA will continue to monitor these activities through its inspections.
The Decree was presented yesterday for consideration by the United States District Court for the Eastern District of North Carolina. The Decree will take effect after it has been signed and entered by the Court.
Emphasis added, Ed.
Source...
comments