FDA Reports

April 22, 2011

FDA Update on Tysabri PML

[04/22/2011] FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare […]
March 4, 2011

FDA Alert: Topamax Oral Clefts Risk in Infants

FDA Drug Safety Communication: Risk of Oral Clefts in Children Born to Mothers Taking Topamax (topiramate) The U.S. Food and Drug Administration (FDA) is informing the […]
February 2, 2011

Lexapro Birth Defect Lawsuit

Children born with cardiac and other congenital birth defects have potentially been linked to use of the SSRI class of antidepressant drugs, including Lexapro (Generic: escitalopram). […]
January 13, 2011

Celexa Birth Defect Lawsuit

Children born with cardiac and other congenital birth defects have potentially been linked to use of the SSRI class of antidepressant drugs, including Celexa (Generic: citalopram). […]
December 17, 2010

Wellbutrin Birth Defect Lawsuit

Children born with cardiac and other congenital birth defects have possibly been linked to use of the anti-depressant drug bupropion (Aplenzin, Wellbutrin, Wellbutrin SR, Wellbutrin XL, […]
December 17, 2010

Zoloft Birth Defect Lawsuit

Children born with a heart defect, lung defect or other congenital birth defects have possibly been linked to use of the antidepressant drug Zoloft. Research suggests […]
November 4, 2010

Actavis Fentanyl Patch Recall

Morristown, NJ – Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to […]
October 18, 2010

FDA – Adverse Reaction Cold Therapy Unit System

FDA Adverse Reaction Cold Therapy System  FDA: Adverse Reaction Model Number 10B Event Date 11/02/2005 Event Type Injury Patient Outcome Required Intervention; Disability Event Description “Ebice […]
August 19, 2010

FDA Warning Letter to DePuy Orthopaedics – Hip Implants

Inspections, Compliance, Enforcement, and Criminal Investigations Depuy Orthopaedics, Inc. 8/19/10 Department of Health and Human Services Public Health ServiceFood and Drug Administration 10903 New Hampshire Avenue […]