Below are images of the warning letter regarding prescribing information for the use of Effexor in children and adolescents. It was sent by Wyeth to health care professionals on August 22, 2003. You may click on each image to see a larger version.
Wyeth letter, page 1:
Wyeth letter, page 2:
Data from Unpublished Trials Suggest that Most SSRI Antidepressant Drugs Unsuitable for Children Wed, 21 Apr 2004 An independent analysis in next week’s The Lancet compares the published and unpublished data of pediatric SSRI antidepressant clinical trial data, finding the published reports not to be evidence-based. “In a global medical…
GlascoSmithKline PAXIL Warning letter to Healthcare Professionals Thu, 19 Jun 2003 On June 10 the British government disapproved a license the widely popular, SSRI antidepressant, Seroxat (PAXIL), for use in children and adolescents after a committee examined the data from 9 clinical trials. The British Medicine and Healthcare Products Regulatory…
MedicAlert lifeline lent to patients in drug trials Thu, 1 May 2003 The Modesto Bee reports that MedicAlert Foundation International which maintains an electronic database of its members’ medical records which are accessible in to treating physicians and paramedics in emergencies, is venturing into the clinical drug trial arena. The…
SSRI Prescription For Murder? CBS News 48 Hours / Interrogation Methods Can Elicit Confessions From Innocent People Sat, 16 Apr 2005 CBS News is broadcasting the Christopher Pittman story–the 16 year old who was tried for murder as an adult for a crime he committed as a 12 year old…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) New York, NY 10023 212-595-8974 July 29, 2002 Greg Koski, MD, Ph.D. Office of the Secretary Office of Public Health and Science Office of Human Research Protection The Tower Building 1101 Wooten Parkway, Suite 200 Rockville, MD 20852 RELATED PAGES OHRP Investigation of…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Proposed Changes to Subpart D Regulations Increase Risks to Children in Non-Therapeutic Research Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations April 18, 2005 The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What…
