Potential safety signals and their significance

Archives of Internal Medicine

Volumn 172, Issue 1, 2012, Pages 72-73

  Powers, Abbey ^a   Cook, G Elliott ^a  

^a LAKE ERIE COLLEGE OF OSTEOPATHIC MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONSUMER; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HUMAN; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG LABELING; PATIENT SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84855596103     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinternmed.2011.525     Document Type: Article

References (7)

1. Food and Drug Cosmetic Act. 21 USC §355 (2008).
2. Center for Drug Evaluation and Research. Adverse Event Reporting System (AERS) Statistics. Food and Drug Administration Web site. http://www.fda.gov/ Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ ucm070093.htm. Accessed May 2, 2011.
3. Center for Drug Evaluation and Research. Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS). Food and Drug Administration Web site. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ ucm082196.htm. Accessed May 2, 2011.
4. Center for Drug Evaluation and Research. Guidance: Drug Safety Information - FDA's Communication to the Public. Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm072281.pdf. Accessed August 24, 2011.
5. Institute for Safe Medication Practices (ISMP). QuarterWatch: 2010 Quarter 2. January 27, 2011. http://www.ismp.org/quarterwatch/2010Q2.pdf. Accessed May 2, 2011.
6. Institute for Safe Medication Practices (ISMP). QuarterWatch: 2010 Quarter 3. May 19, 2011. http://www.ismp.org/quarterwatch/2010Q3.pdf. Accessed May 20, 2011.
7. Tatonetti NP, Denny JC, Murphy SN, et al. Detecting drug interactions from adverse-event reports: interaction between paroxetine and pravastatin increases blood glucose levels [published online May 25, 2011]. Clin Pharmacol Ther. doi:10.1038/clpt.2011.83.