Tarek A Hammad
Affiliation: Food and Drug Administration
- Suicide rates in short-term randomized controlled trials of newer antidepressantsTarek A Hammad
Division of Neuropharmocological Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
J Clin Psychopharmacol 26:203-7. 2006....
- Suicidality in pediatric patients treated with antidepressant drugsTarek A Hammad
Division of Neuropharmacological Drug Products, HFD 120, 5600 Fishers Lane, Rockville, MD 20857, USA
Arch Gen Psychiatry 63:332-9. 2006..There has been concern that widely used antidepressant agents might be associated with an increased risk of suicidal ideation and behavior (suicidality) in pediatric patients...
- Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessmentTarek A Hammad
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 30993, USA
Clin Trials 10:389-97. 2013..However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting...
- Atomoxetine use during a period of FDA actionsDongyi Tony Du
Office of Commissioner, US Food and Drug Administration FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
Med Care 50:987-92. 2012..At FDA's request, the manufacturer subsequently added a boxed warning to the drug's labeling on November 8, 2005...
- Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug AdministrationMarc Stone
Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
BMJ 339:b2880. 2009..To examine the risk of suicidal behaviour within clinical trials of antidepressants in adults...
- Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008Ann W McMahon
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
Pharmacoepidemiol Drug Saf 19:921-33. 2010..The investigation identified Baxter Healthcare-brand heparin product due to its strongest association with the events. Later, oversulfated chondroitin sulfate (OSCS), a heparin-like contaminant, was discovered...
- Predicting nosocomial bloodstream infections using surrogate markers of injury severity: clinical and methodological perspectivesMaher M El-Masri
University of Windsor, Faculty of Nursing, Windsor, Ontario, Canada
Nurs Res 54:273-9. 2005..However, surrogate markers of injury severity (SMIS) may be more clinically meaningful than these commonly used numerical injury severity indices with respect to the control and prevention of nosocomial BSI...