Quarter Watch: 2008 Quarter 1 : QUARTER WATCH PROJECT TEAM *

Moore T.J. , Cohen M.R. , Furberg C.D. Strong safety signal seen for new varenicline risks. Institute of Safe Medication Practices Web site. http://www.ismp.org/docs/vareniclineStudy.asp. Published May 21, 2008. Accessed December 2, 2008.

Lazarou J. , Pomeranz B.H. , Corey P.N. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1988; 279(15): 1200–1205.

Heron M.P. , Hoyert D.L. , Xu J. , Scott C. , Tejada-Vera B. Deaths: Preliminary Data for 2006. National Vital Statistics Reports. Vol 56. No 16. Hyattsville, MD: National Center for Health Statistics; 2008.

Kessler D.A. Introducing MedWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA. 1993; 269(21): 2765–2768.

Brown J.G. Review of the Food and Drug Administration's Handling of Adverse Drug Reaction Reports. A-15-98-50001. Washington, DC: Department of Health and Human Services; 1999.

Liu S. , Ma W. , Moore R. , Ganesan V. , Nelson S. RxNorm: prescription for electronic drug information exchange. IT Pro. 2005;September/October: 17–23. http://www.nlm.nih.gov/research/umls/rxnorm/RxNorm.pdf. Accessed December 2, 2008.

Postmarketing reporting of adverse drug experiences. 21 CFR 314.80. 2006;119–122. http://www.fda.gov/cder/aers/extract.htm. Accessed December 2, 2008.

MedDRA data retrieval and presentation: points to consider. Presented at: International Conference on Harmonization Secretariat; March 2006; Geneva, Switzerland.

Introductory guide for standardized MedDRA queries (SMQs). Version 10.1. 2007. MedDRA Maintenance and Support Services Organization: Chantilly, VA.

Quarterly data extract from the Adverse Event Reporting System (AERS). Revised March 6, 2006. Rockville, MD: US Food and Drug Administration; 2006.

Lamb E. Top 200 prescription drugs of 2007. Pharmacy Times. May 2008.

Public health advisory: important information on Chantix (varenicline). US Food and Drug Administration Web site. http://www.fda.gov/cder/drug/advisory/varenicline.htm. Accessed May 16, 2008.

Medication guide: Chantix (varenicline) tablets. US Food and Drug Administration Web site. http://www.fda.gov/cder/Offices/ODS/MG/ChantixMG.pdf. Accessed December 2, 2008.

Anti-Smoking medicine Chantix banned. Federal Aviation Administration Web site. http://www.faa.gov/news/updates/?newsId=56363. Updated October 28, 2008. Accessed May 23, 2008.

Hill J.H. Statement from Administrator John H. Hill. Federal Motor Carrier Safety Administration Web site. http://www.fmcsa.dot.gov/statement-5-23-08.htm. Accessed December 2, 2008.

Rake J. DoD medication safety notice. Varenicline (Chantix). http://www.health.mil/Content//docs/pdfs/Varenicline%20Safety%20Notice%20final.pdf. Published May 23, 2008. Accessed December 2, 2008.

Rappaport R. Letter to Pfizer Inc re: NDA 21–928/S-008. US Food and Drug Administration Web site. http://www.fda.gov/cder/foi/appletter/2008/021928s008ltr.pdf. Published May 16, 2008. Accessed December 2, 2008.

Grabell M. , Eiserer T. Girlfriend of slain musician cites anti-smoking drug. The Dallas Morning News Web site. http://www.dallasnews.com/sharedcontent/dws/news/city/dallas/stories/DN-musiciandead_05met.ART.State.Edition2.4247864.html. Accessed September 5, 2007.

Questions and answers on heparin sodium injection (Baxter). US Food and Drug Administration Web site. http://www.fda.gov/cder/drug/infopage/heparin/heparinQA.htm. Published February 11, 2008. Updated June 18, 2008. Accessed June 16, 2008.

2008 heparin information. Baxter Healthcare Corporation Web site. http://www.baxter.com/products/biopharmaceuticals/heparin.html. Published May 21, 2008. Accessed December 2, 2008.

Bronstein A.C. , Spkyer D.A. , Cantilena L.R. Jr , Green J. , Rumack B.H. , Heard S.E. 2006 annual report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Clin Toxicol (Phila). 2007; 45(8): 815–917.