Drug-versus-drug adverse event rate comparisons: A pilot study based on data from the US FDA adverse event reporting system

Drug Safety

Volumn 32, Issue 2, 2009, Pages 137-146

  Hochberg, Alan M ^a   Pearson, Ronald K ^a   O'Hara, Donald J ^a   Reisinger, Stephanie J ^a  

^a ProSanos Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBENDAZOLE; ANTHELMINTIC AGENT; ANTIHISTAMINIC AGENT; ANTIMALARIAL AGENT; ATORVASTATIN; ATOVAQUONE; BROMPHENIRAMINE; CETIRIZINE; CHLOROQUINE; CHLORPHENIRAMINE; CIPROFLOXACIN; DICLOFENAC; DIPHENHYDRAMINE; GATIFLOXACIN; INDOMETACIN; KETOROLAC; LEVOFLOXACIN; LORATADINE; MEBENDAZOLE; MEFLOQUINE; MEVINOLIN; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PRAVASTATIN; PROMETHAZINE; PSEUDOEPHEDRINE; QUINOLINE DERIVED ANTIINFECTIVE AGENT; SIMVASTATIN; TRIPROLIDINE; UNINDEXED DRUG;

ACUTE KIDNEY FAILURE; ADVERSE DRUG REACTION; ADVERSE EVENT REPORTING SYSTEM; ARTICLE; BLEEDING; DIARRHEA; DRUG HYPERSENSITIVITY; ECG ABNORMALITY; FEVER; FISHER EXACT TEST; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; HYPOSPADIAS; KAPPA STATISTICS; LIVER FUNCTION TEST; MENTAL DISEASE; NAUSEA; PRIORITY JOURNAL; RHABDOMYOLYSIS; SEDATION; SIDE EFFECT; TECHNOLOGY; TENDON RUPTURE; TORSADE DES POINTES; UPPER ABDOMINAL PAIN; VALIDITY;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; DRUG PRESCRIPTIONS; HUMANS; PHARMACEUTICAL PREPARATIONS; PILOT PROJECTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 60749129610     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200932020-00006     Document Type: Article

References (25)

1. Rodriguez EM, Staffa JA, Graham DJ. The role of databases in drug postmarketing surveillance. Pharmacoepidemiol Drug Saf 2001 Aug-Sep; 10 (5): 407-10
2. Almenoff J, Tonning JM, Gould AL, et al. Perspectives on the use of data mining in pharmaco-vigilance. Drug Saf 2005; 28: 981-1007
3. Szarfman A, Levine J. Memorandum: NDA 21-144 KETEK (telithromycin) 400MG tablets® (Sanofi-Aventis): data mining analysis of adverse events and outcomes reported for telithromycin and 15 comparator drugs (AERS data) [online]. Available from URL: http://www.fda.gov/ohrms/dockets/AC/06/briefing/ 2006-4266b1-02-06-FDA-appendic-f.pdf [Accessed 2007 Feb 21]
4. Frothingham R. Glucose homeostasis abnormalities associated with use of gatifloxacin. Clin Infect Dis 2005 Nov 1; 41 (9): 1269-76
5. Hochberg AM, Reisinger SJ, Pearson RK, et al. Using data mining to predict safety actions from FDA Adverse Event Reporting System data. Drug Inf J 2007; 41 (5): 633-43
6. Hauben M, Reich L, DeMicco J, et al. 'Extreme duplication' in the US FDA Adverse Events Reporting System database. Drug Saf 2007; 30 (6): 551-4
7. Telias D, Nir-Hod J. Buprenorphine-ketorolac vs. clonidine-naproxen in the withdrawal from opioids. Int J Psychosocial Rehab 2000; 5: 29-33
8. Gibbon C, Blockman M, Barnes K, et al., editors. The South African medicines formulary. 7th ed. Cape Town: Division of Clinical Pharmacology, University of Cape Town, 2005
9. Helfand M. Drug class review on newer antihistamines. Portland (OR): Oregon Health & Science University, 2006
10. Loratadine, desloratadine and pregnancy: don't use, risk of hypospadias. Prescrire Int 2003 Oct; 12 (67): 183
11. Centers for Disease Control and Prevention (CDC). Evaluation of an association between loratadine and hypospadias: United States, 1997-2001. MMWR Morb Mortal Wkly Rep 2004 Mar 19; 53 (10): 219-21
12. Schlagenhauf P, Steffen R. Neuropsychiatric events and travel: do antimalarials play a role? J Travel Med 2000; 7: 225-6
13. Camus D, Djossou F, Schilthuis HJ, et al. Atovaquoneproguanil versus chloroquine-proguanil for malaria prophylaxis in nonimmune pediatric travelers: results of an international, randomized, open-label study. Clin Infect Dis 2004 Jun 15; 38 (12): 1716-23
14. Frothingham R. Rates of torsades de pointes associated with ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin. Pharmacotherapy 2001 Dec; 21 (12): 1468-72
15. Park-Wyllie LY, Juurlink DN, Kopp A. Outpatient gatifloxacin therapy and dysglycemia in older adults. N Engl J Med 2006 Mar 30; 354 (13): 1352-61
16. Kashida Y, Kato M. Characterization of fluoroquinolone-induced Achilles tendon toxicity in rats: comparison of toxicities of 10 fluoroquinolones and effects of antiinflammatory compounds. Antimicrob Agents Chemother 1997 Nov; 41 (11): 2389-93
17. Rubenstein E. History of the quinolones and their side effects. Chemotherapy 2001; 47 Suppl. 3: 3-8; discussion 44-8
18. Forrest JB, Camu F, Greer IA, et al. Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. Br J Anaesth 2002 Feb; 88 (2): 227-33
19. Rostom A, Goldkind L, Laine L. Nonsteroidal antiinflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients. Clin Gastroenterol Hepatol 2005 May; 3 (5): 489-98
20. Hippisley-Cox J, Coupland C, Logan R. Risk of adverse gastrointestinal outcomes in patients taking cyclooxygenase-2 inhibitors or conventional non-steroidal antiinflammatory drugs: population based nested case-control analysis. BMJ 2005; 331: 1310-6
21. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006 Apr 17; 97 (8A): 52C-60C
22. Helfand M, Carson S, Kelley C. Drug class review on HMG-CoA reductase inhibitors (statins). Portland (OR): Oregon Health & Science University, 2004
23. Tu RH, Grewall P, Leung JW, et al. Diphenhydramine as an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastrointest Endosc 2006 Jan; 63 (1): 87-94
24. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas 1960; 20: 37-46
25. Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy 2004 Jun; 24 (6): 743-9