The importance of reporting negative findings in data mining: The example of exenatide and pancreatitis

Pharmaceutical Medicine

Volumn 22, Issue 4, 2008, Pages 215-219

  Hauben, Manfred ^a,b,c,d   Hochberg, Alan ^e  

^a PFIZER INC   (United States)

^b NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c NEW YORK MEDICAL COLLEGE   (United States)

^d BRUNEL UNIVERSITY   (United Kingdom)

^e ProSanos Corporation   (United States)

Author keywords

Adverse drug reactions; Adverse reaction monitoring; Exenatide, adverse reactions; Food and Drug Administration; Pancreatitis, drug induced

Indexed keywords

ANTIDIABETIC AGENT; ATORVASTATIN; ATYPICAL ANTIPSYCHOTIC AGENT; CISPLATIN; DIDANOSINE; EXENDIN 4; EZETIMIBE; GABAPENTIN; HYDROCHLOROTHIAZIDE; HYDROCODONE; LAMIVUDINE; LISINOPRIL; MAGNESIUM; METFORMIN; METOPROLOL; MODAFINIL; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OLANZAPINE; PANTOPRAZOLE; PARACETAMOL; QUETIAPINE; RISPERIDONE; RITONAVIR; SIMVASTATIN; TENOFOVIR; VALPROIC ACID;

ALGORITHM; ATTRIBUTABLE RISK; BRADYCARDIA; DATA BASE; DECREASED APPETITE; DIABETES MELLITUS; DIARRHEA; DISEASE ASSOCIATION; DIZZINESS; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPERGLYCEMIA; INFORMATION PROCESSING; INJECTION SITE CONTUSION; NAUSEA; PANCREATITIS; PREGNANCY COMPLICATION; PRIORITY JOURNAL; REVIEW; SENSITIVITY AND SPECIFICITY; SIDE EFFECT; SKIN MANIFESTATION; UNSPECIFIED SIDE EFFECT; VOMITING; WEIGHT REDUCTION; WORLD HEALTH ORGANIZATION;

EID: 52449124309     PISSN: 11782595     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03256706     Document Type: Review

References (16)

1. Gould AL. Practical pharmacovigilance strategies. Pharmacoepidemiol Drug Saf 2003; 12: 559-74
2. Hauben M, Madigan D, Gerrits C, et al. The role of data mining in pharmacovigilance. Expert Opin Drug Saf 2005; 4 (5): 929-48
3. Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA 2007 Jul 11; 298 (2): 194-206
4. Huaben M, Reich L. Communication of findings in pharmacovigilence: use of ther term "signal" and the need for precision in itis use. Eur J Clin Pharmacol 2005 Jul; 61 (5-6): 479-80
5. Hauben M, Van Puijenbroek EP. Evaluation of adverse drug reactions. JAMA 2005; 293 (11): 1324
6. 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
7. Hauben M, Reich L. Drug-induced pancreatitis: lessons in data mining. Br J Clin Pharmacol 2004; 58 (5): 560-2
8. Begaud B, Moride Y, Tubdert-Bitter P, et al. False positives in spontaneous reporting: should we worry about them? Br J Clin Pharmacol 1994; 38: 401-4
9. Sammett D, Greben C, Sayeed-Shah U. Acute pancreatitis caused by penicillin. Dig Dis Sci 1998; 43 (8): 1778-83
10. Hauben M. Application of an empirical Bayesian data mining algorithm to reports of pancreatitis associated with atypical antipsychotics. Pharmacotherapy 2004; 24 (9): 1122-9
11. US Food and Drug Administration. Guidance for industry: providing regulatory submissions in electronic format - content of labelling [online]. Available from URL: http://www.fda.gov/cder/guidance/6719fnl.htm [Accessed 2007 Oct 31]
12. US Food and Drug Administration. Updated safety information: warnings regarding serious rash, including Stevens-Johnson Syndrome and hypersensitivity reactions, and psychiatric symptoms [online]. Available from URL: http://www.fda.gov/Medwatch/SAFETY/2007/Provigil_dhcpletter091207_final.pdf [Accessed 2007 Nov 2]
13. US Food and Drug Administration. CellCept (mycophenolate mofetil) [online]. Available from URL: http://www.fda.gov/Medwatch/SAFETY/2007/safety07. htm#CellCept2 [Accessed 2007 Nov 2]
14. US Food and Drug Administration. Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Revatio (sildenafil) [online]. Available from URL: http://www.fda.gov/Medwatch/SAFETY/2007/safety07.htm#PDE5 [Accessed 2007 Nov 2]
15. Almenoff JS, DuMouchel W, Kindman LA, et al. Disproportionality analysis using empirical Bayes data mining: a tool for the evaluation of drug interactions in the post-marketing setting [erratum in Pharmacoepidemiol Drug Saf 2004; 13: 111]. Pharmacoepidemiol Drug Saf 2003; 12 (6): 517-21
16. Levine JG, Tonning JM, Szarfman A. Erratum: reply. The evaluation of data mining methods for the simultaneous and systematic detection of safety signals in large databases: lessons to be learned. Br J Clin Pharmacol 2007; 64 (1): 118