Manfred Hauben, M.D.

Defining 'surveillance' in drug safety
Aronson, Jeffrey K; Hauben, Manfred; Bate, Andrew
2012 May;35(5):347-357, Drug safety
— id: 165662, year: 2012, vol: 35, page: 347, stat: Journal Article,

Terminological challenges in safety surveillance
Bate, Andrew; Brown, Elliot G; Goldman, Stephen A; Hauben, Manfred
2012 Jan;35(1):79-84, Drug safety
— id: 157306, year: 2012, vol: 35, page: 79, stat: Journal Article,

Paradoxical and bidirectional drug effects
Smith, Silas W; Hauben, Manfred; Aronson, Jeffrey K
2012 Mar;35(3):173-189, Drug safety
— id: 157481, year: 2012, vol: 35, page: 173, stat: Journal Article,

When Databases Collide: The Impact on Data Mining Analysis of Merging Two Large Pharmaceutical Company Safety Data Bases
Hauben, M.; Hung, E.
2011 MAY ;34(10):914-914, Drug safety
— id: 139588, year: 2011, vol: 34, page: 914, stat: Journal Article,

A decade of data mining and still counting
Hauben, Manfred; Noren, G Niklas
2010 Jul 1;33(7):527-534, Drug safety
— id: 133507, year: 2010, vol: 33, page: 527, stat: Journal Article,

Antidepressants that inhibit neuronal norepinephrine reuptake are not associated with increased spontaneous reporting of cardiomyopathy
Ratcliffe, S; Younus, M; Hauben, M; Reich, L
2010 APR ;24(4):503-511, Journal of Psychopharmacology
— id: 109071, year: 2010, vol: 24, page: 503, stat: Journal Article,

Identifying drugs that cause acute thrombocytopenia: an analysis using 3 distinct methods
Reese, Jessica A.; Li, Xiaoning; Hauben, Manfred; Aster, Richard H.; Bougie, Daniel W.; Curtis, Brian R.; George, James N.; Vesely, Sara K.
2010 SEP 23 ;116(12):2127-2133, Blood
— id: 113778, year: 2010, vol: 116, page: 2127, stat: Journal Article,

An experimental investigation of masking in the US FDA adverse event reporting system database
Wang, Hsin-wei; Hochberg, Alan M; Pearson, Ronald K; Hauben, Manfred
2010 Dec 1;33(12):1117-1133, Drug safety
— id: 133830, year: 2010, vol: 33, page: 1117, stat: Journal Article,

Decision support methods for the detection of adverse events in post-marketing data
Hauben, M; Bate, A
2009 APR ;14(7-8):343-357, Drug discovery today
— id: 97973, year: 2009, vol: 14, page: 343, stat: Journal Article,

Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions
Hauben, Manfred; Aronson, Jeffrey K
2009 ;32(2):99-110, Drug safety
— id: 96592, year: 2009, vol: 32, page: 99, stat: Journal Article,

An evaluation of three signal-detection algorithms using a highly inclusive reference event database
Hochberg, Alan M; Hauben, Manfred; Pearson, Ronald K; O'Hara, Donald J; Reisinger, Stephanie J; Goldsmith, David I; Gould, A Lawrence; Madigan, David
2009 ;32(6):509-525, Drug safety
— id: 133691, year: 2009, vol: 32, page: 509, stat: Journal Article,

Time-to-Signal Comparison for Drug Safety Data-Mining Algorithms vs. Traditional Signaling Criteria
Hochberg, AM; Hauben, M
2009 JUN ;85(6):600-606, Clinical pharmacology & therapeutics
— id: 99304, year: 2009, vol: 85, page: 600, stat: Journal Article,

Systematic Investigation of Time Windows for Adverse Event Data Mining for Recently Approved Drugs
Hochberg, AM; Hauben, M; Pearson, RK; O'Hara, DJ; Reisinger, SJ
2009 JUN ;49(6):626-633, Journal of clinical pharmacology
— id: 99254, year: 2009, vol: 49, page: 626, stat: Journal Article,

Influence of the MedDRA((R)) hierarchy on pharmacovigilance data mining results
Pearson, Ronald K; Hauben, Manfred; Goldsmith, David I; Gould, A Lawrence; Madigan, David; O'Hara, Donald J; Reisinger, Stephanie J; Hochberg, Alan M
2009 Dec;78(12):e97-e103, International journal of medical informatics
— id: 96593, year: 2009, vol: 78, page: e97, stat: Journal Article,

The importance of reporting negative findings in data mining: The example of exenatide and pancreatitis
Hauben M.; Hochberg A.
2008 ;22(4):215-219, Pharmaceutical Medicine
— id: 83354, year: 2008, vol: 22, page: 215, stat: Journal Article,

Number needed to detect: Nuances in the use of a simple and intuitive signal detection metric
Hauben M.; Vogel U.; Maignen F.
2008 ;22(1):13-22, International Journal of Pharmaceutical Medicine
— id: 76660, year: 2008, vol: 22, page: 13, stat: Journal Article,

Number needed to detect: Nuances in the use of a simple and intuitive signal detection metric
Hauben M.; Vogel U.; Maignen F.
2008 ;22(1):13-22, Pharmaceutical Medicine
— id: 78675, year: 2008, vol: 22, page: 13, stat: Journal Article,

Drug-induced psoriasis: results from pharmacovigilance tools under investigation
Hauben, Manfred; Reich, Lester; Magliano, Suzanne; Song, Ahyeon
2008 ;27(1):55-59, Cutaneous & ocular toxicology
— id: 96594, year: 2008, vol: 27, page: 55, stat: Journal Article,

Data mining in pharmacovigilance: Computational cost as a neglected performance parameter
Hauben M.; Madigan D.; Hochberg A.M.; Reisinger S.J.; O'Hara D.J.
2007 ;21(5):319-323, International Journal of Pharmaceutical Medicine
— id: 74163, year: 2007, vol: 21, page: 319, stat: Journal Article,

A quantitative analysis of spontaneous reports of muscle injury with proton pump inhibitors
Hauben, M; Calang, B; Vo, T; Reich, L
2007 AUG ;16(4):S231-S232, Pharmacoepidemiology & drug safety
— id: 74176, year: 2007, vol: 16, page: S231, stat: Journal Article,

Hypokalemia associated with infliximab: a pharmacovigilance perspective
Hauben, Manfred
2007 Jul;13(7):935-936, Inflammatory bowel diseases
— id: 96601, year: 2007, vol: 13, page: 935, stat: Journal Article,

Signal detection in the pharmaceutical industry: integrating clinical and computational approaches
Hauben, Manfred
2007 ;30(7):627-630, Drug safety
— id: 96599, year: 2007, vol: 30, page: 627, stat: Journal Article,

Gold standards in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore
Hauben, Manfred; Aronson, Jeffrey K
2007 ;30(8):645-655, Drug safety
— id: 96597, year: 2007, vol: 30, page: 645, stat: Journal Article,

Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions
Hauben, Manfred; Horn, Sebastian; Reich, Lester
2007 ;30(2):143-155, Drug safety
— id: 96602, year: 2007, vol: 30, page: 143, stat: Journal Article,

Association between gastric acid suppressants and Clostridium difficile colitis and community-acquired pneumonia: analysis using pharmacovigilance tools
Hauben, Manfred; Horn, Sebastian; Reich, Lester; Younus, Muhammad
2007 Sep;11(5):417-422, International journal of infectious diseases
— id: 73910, year: 2007, vol: 11, page: 417, stat: Journal Article,

'Extreme duplication' in the US FDA Adverse Events Reporting System database
Hauben, Manfred; Reich, Lester; DeMicco, James; Kim, Katherine
2007 ;30(6):551-554, Drug safety
— id: 96600, year: 2007, vol: 30, page: 551, stat: Journal Article,

Detection of spironolactone-associated hyperkalaemia following the Randomized Aldactone Evaluation Study (RALES)
Hauben, Manfred; Reich, Lester; Gerrits, Charles M; Madigan, David
2007 ;30(12):1143-1149, Drug safety
— id: 96596, year: 2007, vol: 30, page: 1143, stat: Journal Article,

Illusions of objectivity and a recommendation for reporting data mining results
Hauben, Manfred; Reich, Lester; Gerrits, Charles M; Younus, Muhammad
2007 May;63(5):517-521, European journal of clinical pharamacology
— id: 73379, year: 2007, vol: 63, page: 517, stat: Journal Article,

Hepatitis B vaccination and multiple sclerosis: a data mining perspective
Hauben, Manfred; Sakaguchi, Motonobu; Patadia, Vaishali; M Gerrits, Charles
2007 Aug;16(8):943-945, Pharmacoepidemiology & drug safety
— id: 96598, year: 2007, vol: 16, page: 943, stat: Journal Article,

Postmarketing hepatic adverse event experience with PEGylated/non-PEGylated drugs: a disproportionality analysis
Hauben, Manfred; Vegni, Ferdinando; Reich, Lester; Younus, Muhammad
2007 Nov;19(11):934-941, European journal of gastroenterology & hepatology
— id: 96595, year: 2007, vol: 19, page: 934, stat: Journal Article,

Data mining for signals in spontaneous reporting databases: proceed with caution
Stephenson, Wendy P; Hauben, Manfred
2007 Apr;16(4):359-365, Pharmacoepidemiology & drug safety
— id: 96605, year: 2007, vol: 16, page: 359, stat: Journal Article,

Anecdotes that provide definitive evidence
Aronson, Jeffrey K; Hauben, Manfred
2006 Dec 16;333(7581):1267-1269, British medical journal. BMJ (International ed.)
— id: 96603, year: 2006, vol: 333, page: 1267, stat: Journal Article,

Accelerating statistical research in drug safety
Bilker, Warren; Gogolak, Victor; Goldsmith, David; Hauben, Manfred; Herrera, Guillermo; Hochberg, Alan; Jolley, Steve; Kulldorff, Martin; Madigan, David; Nelson, Robert; Shapiro, Alan; Shmueli, Galit
2006 Sep;15(9):687-688, Pharmacoepidemiology & drug safety
— id: 96607, year: 2006, vol: 15, page: 687, stat: Journal Article,

A preliminary comparison of the FDA-AERS database and WHO adverse events database for purpose of data mining
Gerrits, CM; Hauben, M; Patadia, V
2006 AUG ;15(49):S120-S121, Pharmacoepidemiology & drug safety
— id: 69615, year: 2006, vol: 15, page: S120, stat: Journal Article,

The relation between hepatitis B and demyelinating diseases: A data mining analysis of a phantom ship association in VAERS
Gerrits, CM; Sakaguchi, M; Hauben, M
2006 AUG ;15(49):S114-S114, Pharmacoepidemiology & drug safety
— id: 69613, year: 2006, vol: 15, page: S114, stat: Journal Article,

Gold standards in pharmacovigilance: the use of definitive anecdotal adverse drug reactions as pure gold and high grade ore
Hauben, M; Aronson, JK
2006 SEP-OCT ;29(10):953-953, Drug safety
— id: 69008, year: 2006, vol: 29, page: 953, stat: Journal Article,

Paradoxical reactions: Under-recognized adverse effects of drugs?
Hauben, M; Aronson, JK
2006 SEP-OCT ;29(10):970-970, Drug safety
— id: 69010, year: 2006, vol: 29, page: 970, stat: Journal Article,

A data mining analysis in two spontaneous reporting system databases using placebo-associated adverse events as 'true negatives'
Hauben, M; Hirsch, D; Reich, L
2006 AUG ;15(49):S129-S130, Pharmacoepidemiology & drug safety
— id: 69619, year: 2006, vol: 15, page: S129, stat: Journal Article,

Reply: The evaluation of data mining methods for the simultaneous and systematic detection of safety signals in large databases: lessons to be learned - Response to letter by Levine et al
Hauben, M; Reich, L
2006 JAN ;61(1):115-117, British journal of clinical pharmacology
— id: 60235, year: 2006, vol: 61, page: 115, stat: Journal Article,

Reports of acute angle closure glaucoma-related adverse events with SSRIs: Results of a disproportionality analysis
Hauben, M; Reich, L
2006 MAY 9 ;20(4):327-329, CNS drugs
— id: 64401, year: 2006, vol: 20, page: 327, stat: Journal Article,

Reports of acute angle closure glaucoma-related adverse events with SSRIs: Results of a disproportionality analysis
Hauben, M; Reich, L
2006 AUG ;15(49):S107-S108, Pharmacoepidemiology & drug safety
— id: 69611, year: 2006, vol: 15, page: S107, stat: Journal Article,

Spontaneous reports of asthma-related adverse events with acetaminophen: Results of a disproportionality analysis
Hauben, M; Reich, L
2006 AUG ;15(49):S113-S113, Pharmacoepidemiology & drug safety
— id: 69612, year: 2006, vol: 15, page: S113, stat: Journal Article,

Use of data mining as an adjunct to prospective pharmacovigilance of 'mature' or 'old' products
Hauben, M; Reich, L
2006 AUG ;15(49):S132-S132, Pharmacoepidemiology & drug safety
— id: 69620, year: 2006, vol: 15, page: S132, stat: Journal Article,

Extension of points on clarifying terminology in drug safety
Hauben, M; Reich, L; Gabbay, F
2006 MAY 15 ;29(3):273-275, Drug safety
— id: 63307, year: 2006, vol: 29, page: 273, stat: Journal Article,

Illusion of objectivity and recommendations for reporting data mining results
Hauben, M; Reich, L; Gerrits, C
2006 AUG ;15(49):S114-S115, Pharmacoepidemiology & drug safety
— id: 69614, year: 2006, vol: 15, page: S114, stat: Journal Article,

Reports of hyperkalemia after publication of rales - A pharmacovigilance study
Hauben, M; Reich, L; Gerrits, C
2006 AUG ;15(49):S123-S123, Pharmacoepidemiology & drug safety
— id: 69616, year: 2006, vol: 15, page: S123, stat: Journal Article,

Potential use of data mining algorithms for the detection of 'Surprise' adverse drug reactions
Hauben, M; Reich, L; Horn, S
2006 AUG ;15(49):S126-S126, Pharmacoepidemiology & drug safety
— id: 69617, year: 2006, vol: 15, page: S126, stat: Journal Article,

Drug-induced psoriasis: Results from phormacovigilance tools under investigation
Hauben, M; Reich, L; Magliano, S; Song, A
2006 SEP-OCT ;29(10):944-944, Drug safety
— id: 69007, year: 2006, vol: 29, page: 944, stat: Journal Article,

Hepatic dysfunction and pegylated/non-pegylated compounds: Findings from a disproportionality analysis in the who database
Hauben, M; Reich, L; Younus, M
2006 SEP-OCT ;29(10):955-955, Drug safety
— id: 69009, year: 2006, vol: 29, page: 955, stat: Journal Article,

What counts in data mining?
Hauben, Manfred; Patadia, Vaishali K; Goldsmith, David
2006 ;29(10):827-832, Drug safety
— id: 96606, year: 2006, vol: 29, page: 827, stat: Journal Article,

Reports of hyperkalemia after publication of RALES--a pharmacovigilance study
Hauben, Manfred; Reich, Lester; Gerrits, Charles M
2006 Nov;15(11):775-783, Pharmacoepidemiology & drug safety
— id: 96609, year: 2006, vol: 15, page: 775, stat: Journal Article,

Data mining in pharmacovigilance: lessons from phantom ships
Hauben, Manfred; Reich, Lester; Van Puijenbroek, Eugene P; Gerrits, Charles M; Patadia, Vaishali K
2006 Nov;62(11):967-970, European journal of clinical pharamacology
— id: 96608, year: 2006, vol: 62, page: 967, stat: Journal Article,

Rosiglitazone-induced immune thrombocytopenia
Hauben, Manfred; Younus, Muhammad
2006 Dec;17(8):591-593, Platelets
— id: 96604, year: 2006, vol: 17, page: 591, stat: Journal Article,

Pharmacovigilance and pharmacoepidemiology of gastric acid suppressants and risk of C-difficile Colitis: Scientific developments at the interface of clinical medicine and public health
Reich, L; Hauben, M
2006 AUG ;15(49):S128-S128, Pharmacoepidemiology & drug safety
— id: 69618, year: 2006, vol: 15, page: S128, stat: Journal Article,

Perspectives on the use of data mining in pharmacovigilance
Almenoff, J; Tonning, JM; Gould, AL; Szarfman, A; Hauben, M; Ouellet-Hellstrom, R; Ball, R; Hornbuckle, K; Walsh, L; Yee, C; Sacks, ST; Yuen, N; Patadia, V; Blum, M; Johnston, M; Gerrits, C; Seifert, H; LaCroix, K
2005 SEP ;28(11):981-1007, Drug safety
— id: 59593, year: 2005, vol: 28, page: 981, stat: Journal Article,

Signal detection in pharmacovigilance: empirical evaluation of data mining tools
Chan, KA; Hauben, M
2005 SEP ;14(9):597-599, Pharmacoepidemiology & drug safety
— id: 58084, year: 2005, vol: 14, page: 597, stat: Journal Article,

Data mining in pharmacovigilance - The need for a balanced perspective
Hauben, M; Patadia, V; Gerrits, C; Walsh, L; Reich, L
2005 NOV ;28(10):835-842, Drug safety
— id: 59267, year: 2005, vol: 28, page: 835, stat: Journal Article,

Case reports of dobutamine-induced myoclonia in severe renal failure: potential of emerging pharmacovigilance technologies
Hauben, M; Reich, L
2005 FEB ;20(2):471-472, Nephrology, dialysis, transplantation
— id: 48738, year: 2005, vol: 20, page: 471, stat: Journal Article,

Communication of findings in pharmacovigilance: use of the term "signal" and the need for precision in its use
Hauben, M; Reich, L
2005 JUL ;61(5-6):479-480, European journal of clinical pharamacology
— id: 57666, year: 2005, vol: 61, page: 479, stat: Journal Article,

Potential utility of data-mining algorithms for early detection of potentially fatal/disabling adverse drug reactions: A retrospective evaluation
Hauben, M; Reich, L
2005 APR ;45(4):378-384, Journal of clinical pharmacology
— id: 50155, year: 2005, vol: 45, page: 378, stat: Journal Article,

Valproate-induced parkinsonism: Use of a newer pharmacovigilance tool to investigate the reporting of an unanticipated adverse event with an "old" drug
Hauben, M; Reich, L
2005 MAR ;20(3):387-387, Movement disorders
— id: 50418, year: 2005, vol: 20, page: 387, stat: Journal Article,

Application of an empiric Bayesian data mining algorithm to reports of pancreatitis associated with atypical antipsychotics
Hauben, M
2004 SEP ;24(9):1122-1129, Pharmacotherapy
— id: 46524, year: 2004, vol: 24, page: 1122, stat: Journal Article,

Data mining, drug safety, and molecular pharmacology: potential for collaboration
Hauben, M; Reich, L
2004 DEC ;38(12):2174-2175, Annals of pharmacotherapy
— id: 47215, year: 2004, vol: 38, page: 2174, stat: Journal Article,

Drug-induced pancreatitis: lessons in data mining
Hauben, M; Reich, L
2004 NOV ;58(5):560-562, British journal of clinical pharmacology
— id: 46888, year: 2004, vol: 58, page: 560, stat: Journal Article,

Safety related drug-labelling changes
Hauben, M; Reich, L
2004 SEP 10 ;27(10):735-744, Drug safety
— id: 46525, year: 2004, vol: 27, page: 735, stat: Journal Article,

Postmarketing surveillance of potentially fatal reactions to oncology drugs: potential utility of two signal-detection algorithms
Hauben, M; Reich, L; Chung, S
2004 DEC ;60(10):747-750, European journal of clinical pharamacology
— id: 47749, year: 2004, vol: 60, page: 747, stat: Journal Article,

Early postmarketing drug safety surveillance: data mining points to consider
Hauben, Manfred
2004 Oct;38(10):1625-1630, Annals of pharmacotherapy
— id: 62331, year: 2004, vol: 38, page: 1625, stat: Journal Article,

A brief primer on automated signal detection
Hauben, Manfred
2003 Jul-Aug;37(7-8):1117-1123, Annals of pharmacotherapy
— id: 62324, year: 2003, vol: 37, page: 1117, stat: Journal Article,

Comment: phenytoin/isradipine interaction causing severe neurologic toxicity
Hauben, M
2002 DEC ;36(12):1974-1975, Annals of pharmacotherapy
— id: 33277, year: 2002, vol: 36, page: 1974, stat: Journal Article,

Re: Lasso-de-la-Vega et al. Gabapentin as a probable cause of hepatotoxicity and eosinophilia
Hauben, M
2002 Aug;97(8):2156-2157, American journal of gastroenterology
— id: 32377, year: 2002, vol: 97, page: 2156, stat: Journal Article,

The association of St. John's wort with elevated thyroid- stimulating hormone
Hauben, M
2002 May;22(5):673-, Pharmacotherapy
— id: 27454, year: 2002, vol: 22, page: 673, stat: Journal Article,

Comments on "Hypotension associated with intravenous haloperidol and imipenem
Hauben M
2001 Jun;21(3):345-347, Journal of clinical psychopharmacology
— id: 27229, year: 2001, vol: 21, page: 345, stat: Journal Article,

Comment: use of epidural corticosteroids in low back pain
Hauben M
2000 Dec;34(12):1489-1489, Annals of pharmacotherapy
— id: 27230, year: 2000, vol: 34, page: 1489, stat: Journal Article,

Comment: papular rash and bilateral pleural effusion associated with clozapine
Hauben M
1999 Dec;33(12):1374-1374, Annals of pharmacotherapy
— id: 27231, year: 1999, vol: 33, page: 1374, stat: Journal Article,

Sudden death in a patient taking antipsychotic drugs
Hauben M
1999 Feb;75(880):127-127, Postgraduate medical journal
— id: 27232, year: 1999, vol: 75, page: 127, stat: Journal Article,

Cyclosporine neurotoxicity
Hauben M
1996 Jul-Aug;16(4):576-583, Pharmacotherapy
— id: 27233, year: 1996, vol: 16, page: 576, stat: Journal Article,

Severe adverse cutaneous reactions to drugs
Hauben M
1995 Apr 6;332(14):959; author reply 959-959; author reply 960, New England journal of medicine
— id: 27236, year: 1995, vol: 332, page: 959; author reply 959, stat: Journal Article,

Acute hepatitis, interstitial nephritis, and eosinophilia
Hauben M; Adler C
1995 Apr 1;122(7):555-556, Annals of internal medicine
— id: 27237, year: 1995, vol: 122, page: 555, stat: Journal Article,

Feigned adverse drug reaction to radiographic contrast material
Hauben M; Fortunate BR; Frederick J
1995 Aug;165(2):484-484, American journal of roentgenology
— id: 27235, year: 1995, vol: 165, page: 484, stat: Journal Article,

Multiple cholesterol emboli syndrome--six cases identified through the spontaneous reporting system
Hauben M; Norwich J; Shapiro E; Reich L; Petchel KS; Goldsmith D
1995 Sep;46(9):779-784, Angiology
— id: 27234, year: 1995, vol: 46, page: 779, stat: Journal Article,

Clinical problem-solving: assembling a coherent story
Hauben M
1994 Jun 2;330(22):1618-1618, New England journal of medicine
— id: 27239, year: 1994, vol: 330, page: 1618, stat: Journal Article,

Comment: evening primrose oil in the treatment of rheumatoid arthritis--proper application of statistical analysis
Hauben M
1994 Jul-Aug;28(7-8):973-973, Annals of pharmacotherapy
— id: 27238, year: 1994, vol: 28, page: 973, stat: Journal Article,

Quinacrine and chronic fatigue syndrome
Hauben M
1994 May 1;49(6):1354-1354, American family physician
— id: 27240, year: 1994, vol: 49, page: 1354, stat: Journal Article,

Clinical problem-solving: one more hypothesis
Hauben M
1993 Dec 9;329(24):1821-1821, New England journal of medicine
— id: 27241, year: 1993, vol: 329, page: 1821, stat: Journal Article,

Seizures after povidone-iodine mediastinal irrigation
Hauben M
1993 Feb 4;328(5):355; author reply 356-355; author reply 356, New England journal of medicine
— id: 27242, year: 1993, vol: 328, page: 355; author reply 356, stat: Journal Article,