-
1
-
-
0022628247
-
Adverse-drug-reaction monitoring
-
Faich GA. Adverse-drug-reaction monitoring. N Engl J Med 1986; 314: 1589-92.
-
(1986)
N Engl J Med
, vol.314
, pp. 1589-1592
-
-
Faich, G.A.1
-
2
-
-
84973810357
-
Sources of spontaneous adverse drug reaction reports received by pharmaceutical manufacturers
-
Faich GA, Milstien JB, Anello C, Baum C. Sources of spontaneous adverse drug reaction reports received by pharmaceutical manufacturers. Drug Info J 1987; 21: 251-5.
-
(1987)
Drug Info J
, vol.21
, pp. 251-255
-
-
Faich, G.A.1
Milstien, J.B.2
Anello, C.3
Baum, C.4
-
3
-
-
84889338666
-
Annual Adverse Drug Reaction Report
-
Report of Surveillance Section, Surveillance and Data Processing Branch, Division of Epidemiology and Surveillance, Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, FDA
-
Knapp DE, Perry ZA. Annual Adverse Drug Reaction Report: 1989. Report of Surveillance Section, Surveillance and Data Processing Branch, Division of Epidemiology and Surveillance, Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, FDA.
-
(1989)
-
-
Knapp, D.E.1
Perry, Z.A.2
-
4
-
-
0037238861
-
Adverse drug event monitoring at the Food and Drug Administration
-
Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med 2003; 18: 57-60.
-
(2003)
J Gen Intern Med
, vol.18
, pp. 57-60
-
-
Ahmad, S.R.1
-
5
-
-
0032435098
-
Premarketing studies in the drug approval process: understanding their limitations regarding the assessment of drug safety
-
Laughren T. Premarketing studies in the drug approval process: understanding their limitations regarding the assessment of drug safety. Clin Ther 1998; 20 (suppl C): C12-19.
-
(1998)
Clin Ther
, vol.20
, Issue.SUPPL. C
-
-
Laughren, T.1
-
6
-
-
33749043388
-
Managing the Risks from Medical Product Use
-
FDA, Rockville, MD: Food and Drug Administration, May
-
FDA. Managing the Risks from Medical Product Use. Report to the FDA Commissioner from the Task Force on Risk Management. Rockville, MD: Food and Drug Administration, May 1999.
-
(1999)
Report to the FDA Commissioner from the Task Force on Risk Management.
-
-
-
7
-
-
0027231164
-
Incidence and preventability of adverse drug events in hospitalized adults
-
Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med 1993; 8: 289-94.
-
(1993)
J Gen Intern Med
, vol.8
, pp. 289-294
-
-
Bates, D.W.1
Leape, L.L.2
Petrycki, S.3
-
8
-
-
0142222870
-
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
-
New York: Knopf
-
Hilts PJ. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. New York: Knopf, 2003.
-
(2003)
-
-
Hilts, P.J.1
-
9
-
-
43349088882
-
The Long Struggle for the 1906 Law
-
FDA Consumer, June, Available at
-
FDA Consumer. The Long Struggle for the 1906 Law, June 1981. Available at: http://www.cfsan.fda.gov/~lrd/history2.html.
-
(1981)
-
-
-
10
-
-
85012170679
-
Food and Drug Legislation in the New Deal
-
Princeton, NJ: Princeton University Press
-
Jackson CO. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press, 1970.
-
(1970)
-
-
Jackson, C.O.1
-
11
-
-
10844289903
-
Adverse Reactions
-
New York: Morrow
-
Maeder T. Adverse Reactions. New York: Morrow, 1994.
-
(1994)
-
-
Maeder, T.1
-
12
-
-
0015243383
-
The obituary of an idea
-
Moser RH. The obituary of an idea. JAMA 1971; 216: 2135-6.
-
(1971)
JAMA
, vol.216
, pp. 2135-2136
-
-
Moser, R.H.1
-
13
-
-
84889276744
-
Reporting adverse reactions to drugs
-
Kerlan I. Reporting adverse reactions to drugs. Bull Am Soc Hosp Pharm 1956; 13: 311-14.
-
(1956)
Bull Am Soc Hosp Pharm
, vol.13
, pp. 311-314
-
-
Kerlan, I.1
-
14
-
-
84889498749
-
Monthly Report: Adverse Reactions to Drugs and Therapeutic Devices
-
FDA, Report of Adverse Reaction Branch, Division of Medical Information, Bureau of Medicine, August
-
FDA. Monthly Report: Adverse Reactions to Drugs and Therapeutic Devices. Report of Adverse Reaction Branch, Division of Medical Information, Bureau of Medicine, August 1965.
-
(1965)
-
-
-
15
-
-
84889319299
-
Semi-Monthly Adverse Reaction Alert Report and Reactions of Clinical Significance
-
FDA, Report of Division of Drug Experience, October
-
FDA. Semi-Monthly Adverse Reaction Alert Report and Reactions of Clinical Significance. Report of Division of Drug Experience, October 1968.
-
(1968)
-
-
-
16
-
-
0343611636
-
Adverse experience reporting requirements for licensed biological products: final rule
-
Adverse experience reporting requirements for licensed biological products: final rule. Fed Regist 1994; 59: 54034-44.
-
(1994)
Fed Regist
, vol.59
, pp. 54034-54044
-
-
-
17
-
-
0343060625
-
Expedited safety reporting requirements for human drug and biological products: final rule
-
Expedited safety reporting requirements for human drug and biological products: final rule. Fed Regist 1997; 62: 52237-53.
-
(1997)
Fed Regist
, vol.62
, pp. 52237-52253
-
-
-
18
-
-
0006204861
-
Dietary Supplement Health and Education Act (DSHEA) of 1994
-
103rd Congress
-
Dietary Supplement Health and Education Act (DSHEA) of 1994, Public Law 103-417, 103rd Congress.
-
Public Law
, pp. 103-417
-
-
-
19
-
-
84889374645
-
FDA's response to food, dietary supplement, and cosmetic adverse events
-
FDA Consumer July/August
-
Bren L. FDA's response to food, dietary supplement, and cosmetic adverse events. FDA Consumer July/August, 2003.
-
(2003)
-
-
Bren, L.1
-
20
-
-
0342443043
-
Guidelines for Postmarketing Reporting of Adverse Drug Experiences
-
FDA Center for Drug Evaluation and Research, Rockville, MD: CDER
-
FDA Center for Drug Evaluation and Research. Guidelines for Postmarketing Reporting of Adverse Drug Experiences. Rockville, MD: CDER, 1992.
-
(1992)
-
-
-
21
-
-
0005756493
-
Guideline for Adverse Experience Reporting for Licensed Biological Products
-
FDA Center for Drug Evaluation and Research, Rockville, MD: CDER
-
FDA Center for Drug Evaluation and Research. Guideline for Adverse Experience Reporting for Licensed Biological Products. Rockville, MD: CDER, 1993.
-
(1993)
-
-
-
22
-
-
0007855537
-
Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
-
FDA, May 19, Fed Regist 1997
-
FDA. Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, May 19, 1997 Fed Regist 1997; 62: 27470-6.
-
(1997)
, vol.62
, pp. 27470-27476
-
-
-
23
-
-
84889450996
-
Public Law 101-629
-
Safe Medical Devices Act of 1990
-
Safe Medical Devices Act of 1990. Public Law 101-629. Stat 1990; 104: 4511.
-
(1990)
Stat
, vol.104
, pp. 4511
-
-
-
24
-
-
84889343547
-
-
JCAHO, Available at
-
JCAHO. Available at: http://www.hosp.uky.edu/pharmacy/departpolicy/PH03-02.pdf.
-
-
-
-
25
-
-
84862485937
-
ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting
-
American Society of Health-System Pharmacists, Available at
-
American Society of Health-System Pharmacists. ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting. Available at: http://www.ashp.org/bestpractices/MedMis/MedMis_Gdl_ADR.pdf.
-
-
-
-
26
-
-
0028097153
-
Reporting adverse drug and medical device events: report of the AMA's Council on Ethical and Judicial Affairs
-
American Medical Association
-
American Medical Association. Reporting adverse drug and medical device events: report of the AMA's Council on Ethical and Judicial Affairs. Food Drug Law J 1994; 49: 359-66.
-
(1994)
Food Drug Law J
, vol.49
, pp. 359-366
-
-
-
27
-
-
84889327072
-
Advisory Opinion 5.D.1, Reporting Adverse Reactions
-
American Dental Association, January
-
American Dental Association. Advisory Opinion 5.D.1, Reporting Adverse Reactions. Principles of Ethics and Code of Professional Conduct, January 2004.
-
(2004)
Principles of Ethics and Code of Professional Conduct
-
-
-
28
-
-
0345456283
-
JAMA instructions for authors
-
Anonymous
-
Anonymous. JAMA instructions for authors. JAMA 2004; 291: 125-30.
-
(2004)
JAMA
, vol.291
, pp. 125-130
-
-
-
29
-
-
0032539163
-
Reporting of public health hazards or major advances-revision of uniform requirements
-
Glass RM. Reporting of public health hazards or major advances-revision of uniform requirements. JAMA 1998; 280: 2035.
-
(1998)
JAMA
, vol.280
, pp. 2035
-
-
Glass, R.M.1
-
30
-
-
0027252647
-
Introducing MedWatch: a new approach to reporting medication and device adverse effects and product problems
-
Kessler DA. Introducing MedWatch: a new approach to reporting medication and device adverse effects and product problems. JAMA 1993; 269: 2765-829.
-
(1993)
JAMA
, vol.269
, pp. 2765-2829
-
-
Kessler, D.A.1
-
31
-
-
0012686702
-
MedWatch
-
Ahmad SR. MedWatch. Lancet 1993; 341: 1465.
-
(1993)
Lancet
, vol.341
, pp. 1465
-
-
Ahmad, S.R.1
-
32
-
-
84889344587
-
Clinical therapeutics and the recognition of drug-induced disease, MedWatch continuing education article
-
FDA MedWatch, Available at
-
FDA MedWatch. Clinical therapeutics and the recognition of drug-induced disease, MedWatch continuing education article. Available at: http://www.fda.gov/medwatch/articles/dig/ceart.pdf.
-
-
-
-
33
-
-
0042651920
-
Protecting the identities of reporters of adverse events and patients: preemption of disclosure rules
-
Protecting the identities of reporters of adverse events and patients: preemption of disclosure rules. Fed Regist 1995; 60: 16962-8.
-
(1995)
Fed Regist
, vol.60
, pp. 16962-16968
-
-
-
34
-
-
9044239678
-
Quality of adverse drug experience reports submitted by pharmacists and physicians to the FDA
-
Ahmad SR, Freiman JP, Graham DJ, Nelson RC. Quality of adverse drug experience reports submitted by pharmacists and physicians to the FDA. Pharmacoepidemiol Drug Saf 1996; 5: 1-7.
-
(1996)
Pharmacoepidemiol Drug Saf
, vol.5
, pp. 1-7
-
-
Ahmad, S.R.1
Freiman, J.P.2
Graham, D.J.3
Nelson, R.C.4
-
35
-
-
0012761682
-
Spontaneous Reporting-USA
-
Mann R, Andrews E, eds, Chichester: John Wiley & Sons
-
Graham DJ, Ahmad SR, Piazza-Hepp T. Spontaneous Reporting-USA. In: Mann R, Andrews E, eds, Pharmacovigilance. Chichester: John Wiley & Sons, 2002; pp. 219-27.
-
(2002)
Pharmacovigilance.
, pp. 219-227
-
-
Graham, D.J.1
Ahmad, S.R.2
Piazza-Hepp, T.3
-
36
-
-
0034694849
-
Contraindicated use of cisapride: impact of food and drug administration regulatory action
-
Smalley W, Shatin D, Wysowski DK, Gurwitz J, Andrade SE, Goodman M et al. Contraindicated use of cisapride: impact of food and drug administration regulatory action. JAMA 2000; 284: 3036-9.
-
(2000)
JAMA
, vol.284
, pp. 3036-3039
-
-
Smalley, W.1
Shatin, D.2
Wysowski, D.K.3
Gurwitz, J.4
Andrade, S.E.5
Goodman, M.6
-
37
-
-
0035880320
-
Liver enzyme monitoring in patients treated with troglitazone
-
Graham DJ, Drinkard CR, Shatin D, Tsong Y, Burgess MJ. Liver enzyme monitoring in patients treated with troglitazone. JAMA 2001; 286: 831-3.
-
(2001)
JAMA
, vol.286
, pp. 831-833
-
-
Graham, D.J.1
Drinkard, C.R.2
Shatin, D.3
Tsong, Y.4
Burgess, M.J.5
-
39
-
-
2942588779
-
Peripheral neuropathy in patients treated with leflunomide
-
Bonnel RA, Graham DJ. Peripheral neuropathy in patients treated with leflunomide. Clin Pharm Therapeutics 2004; 75: 580-5.
-
(2004)
Clin Pharm Therapeutics
, vol.75
, pp. 580-585
-
-
Bonnel, R.A.1
Graham, D.J.2
-
40
-
-
2942724424
-
High frequency of use of rofecoxib at greater than recommended doses: cause for concern
-
Griffin MR, Stein CM, Graham DJ, Daugherty JR, Arbogast PG, Ray WA. High frequency of use of rofecoxib at greater than recommended doses: cause for concern. Pharmacoepidemiol Drug Saf 2004; 13: 339-43.
-
(2004)
Pharmacoepidemiol Drug Saf
, vol.13
, pp. 339-343
-
-
Griffin, M.R.1
Stein, C.M.2
Graham, D.J.3
Daugherty, J.R.4
Arbogast, P.G.5
Ray, W.A.6
-
41
-
-
4444235845
-
Acute pulmonary edema in association with amiodarone
-
Brinker A, Johnston M. Acute pulmonary edema in association with amiodarone. Chest 2004; 125: 1591-2.
-
(2004)
Chest
, vol.125
, pp. 1591-1592
-
-
Brinker, A.1
Johnston, M.2
-
42
-
-
12144290895
-
Finasteride and benign prostatic hyperplasia
-
Wysowski DK, Farinas E. Finasteride and benign prostatic hyperplasia. N Engl J Med 2004; 350: 1359.
-
(2004)
N Engl J Med
, vol.350
, pp. 1359
-
-
Wysowski, D.K.1
Farinas, E.2
-
44
-
-
0344119574
-
Lithium interaction with the cyclooxygenase 2 inhibitors rofecoxib and celecoxib and other nonsteroidal antiinflammatory drugs
-
Phelan K, Mosholder A, Lu S. Lithium interaction with the cyclooxygenase 2 inhibitors rofecoxib and celecoxib and other nonsteroidal antiinflammatory drugs. J Clin Psychiatry 2003; 64: 1328-34.
-
(2003)
J Clin Psychiatry
, vol.64
, pp. 1328-1334
-
-
Phelan, K.1
Mosholder, A.2
Lu, S.3
-
45
-
-
0142025453
-
Renal failure with the use of zoledronic acid
-
Chang JT, Green L, Beitz J. Renal failure with the use of zoledronic acid. N Engl J Med 2003; 349: 1676-8.
-
(2003)
N Engl J Med
, vol.349
, pp. 1676-1678
-
-
Chang, J.T.1
Green, L.2
Beitz, J.3
-
50
-
-
0037329198
-
Allergic contact dermatitis from topical doxepin: Food and Drug Administration's postmarketing surveillance experience
-
Bonnel RA, La Grenade L, Karwoski CB, Beitz J. Allergic contact dermatitis from topical doxepin: Food and Drug Administration's postmarketing surveillance experience. J Am Acad Dermatol 2003; 48: 294-6.
-
(2003)
J Am Acad Dermatol
, vol.48
, pp. 294-296
-
-
Bonnel, R.A.1
La Grenade, L.2
Karwoski, C.B.3
Beitz, J.4
-
51
-
-
0742307185
-
The risk of esophageal obstruction associated with an anti-allergy medication (Claritin-D 24-Hour-original formulation)
-
Manda B, Drinkard CR, Shatin D, Graham DJ. The risk of esophageal obstruction associated with an anti-allergy medication (Claritin-D 24-Hour-original formulation). Pharmacoepidemiol Drug Saf 2004; 13: 29-34.
-
(2004)
Pharmacoepidemiol Drug Saf
, vol.13
, pp. 29-34
-
-
Manda, B.1
Drinkard, C.R.2
Shatin, D.3
Graham, D.J.4
-
52
-
-
0037259315
-
Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazone
-
Graham DJ, Drinkard CR, Shatin D. Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazone. Am J Gastroenterol 2003; 98: 175-9.
-
(2003)
Am J Gastroenterol
, vol.98
, pp. 175-179
-
-
Graham, D.J.1
Drinkard, C.R.2
Shatin, D.3
-
53
-
-
0037329047
-
Isotretinoin (Accutane) and serious psychiatric adverse events
-
O'Connell KA, Wilkin JK, Pitts M. Isotretinoin (Accutane) and serious psychiatric adverse events. J Am Acad Dermatol 2003; 48: 306-8.
-
(2003)
J Am Acad Dermatol
, vol.48
, pp. 306-308
-
-
O'Connell, K.A.1
Wilkin, J.K.2
Pitts, M.3
-
54
-
-
0037163460
-
Concurrent use of selected agents with moxifloxacin: an examination of labeling compliance within 1 year of marketing
-
Brinker A, Staffa J. Concurrent use of selected agents with moxifloxacin: an examination of labeling compliance within 1 year of marketing. Arch Intern Med 2002; 162: 2011-2.
-
(2002)
Arch Intern Med
, vol.162
, pp. 2011-2012
-
-
Brinker, A.1
Staffa, J.2
-
55
-
-
0036738661
-
Incident diabetes associated with antipsychotic use in the United Kingdom General Practice Research Database
-
Kornegay CJ, Vasilakis-Scaramozza C, Jick H. Incident diabetes associated with antipsychotic use in the United Kingdom General Practice Research Database. J Clin Psychiatry 2002; 63: 758-62.
-
(2002)
J Clin Psychiatry
, vol.63
, pp. 758-762
-
-
Kornegay, C.J.1
Vasilakis-Scaramozza, C.2
Jick, H.3
-
56
-
-
0036333425
-
Topiramate-associated secondary angel-closure glaucoma: a case series
-
Thambi L, Kapcala LP, Chambers W, Nourjah P, Beitz J, Chen M et al. Topiramate-associated secondary angel-closure glaucoma: a case series. Arch Ophthal 2002; 120: 1108.
-
(2002)
Arch Ophthal
, vol.120
, pp. 1108
-
-
Thambi, L.1
Kapcala, L.P.2
Chambers, W.3
Nourjah, P.4
Beitz, J.5
Chen, M.6
-
57
-
-
0036317544
-
Deaths associated with inappropriate intravenous colchicine administration
-
Bonnel RA, Villaba ML, Karwoski CB, Beitz J. Deaths associated with inappropriate intravenous colchicine administration. J Emergency Med 2002; 22: 385-7.
-
(2002)
J Emergency Med
, vol.22
, pp. 385-387
-
-
Bonnel, R.A.1
Villaba, M.L.2
Karwoski, C.B.3
Beitz, J.4
-
58
-
-
0036316351
-
Renal failure associated with the use of celecoxib and rofecoxib
-
Ahmad SR, Kortepeter C, Brinker A, Chen M, Beitz J. Renal failure associated with the use of celecoxib and rofecoxib. Drug Saf 2002; 25: 537-44.
-
(2002)
Drug Saf
, vol.25
, pp. 537-544
-
-
Ahmad, S.R.1
Kortepeter, C.2
Brinker, A.3
Chen, M.4
Beitz, J.5
-
59
-
-
0037100316
-
Concomitant risk factors in reports of torsades de pointes associated with macrolide use: review of the United States Food and Drug Administration Adverse Event Reporting System
-
Shaffer D, Singer S, Korvick J, Honig P. Concomitant risk factors in reports of torsades de pointes associated with macrolide use: review of the United States Food and Drug Administration Adverse Event Reporting System. Clin Infect Dis 2002; 35: 197-200.
-
(2002)
Clin Infect Dis
, vol.35
, pp. 197-200
-
-
Shaffer, D.1
Singer, S.2
Korvick, J.3
Honig, P.4
-
60
-
-
0037030714
-
Uterine sarcoma associated with tamoxifen use
-
Wysowski DK, Honig SF, Beitz J. Uterine sarcoma associated with tamoxifen use. N Engl J Med 2002; 346: 1832-3.
-
(2002)
N Engl J Med
, vol.346
, pp. 1832-1833
-
-
Wysowski, D.K.1
Honig, S.F.2
Beitz, J.3
-
61
-
-
0036606909
-
Comparison of reported and expected deaths in sildenafil (Viagra) users
-
Wysowski DK, Farinas E, Swartz L. Comparison of reported and expected deaths in sildenafil (Viagra) users. Am J Cardiol 2002; 89: 1331-4.
-
(2002)
Am J Cardiol
, vol.89
, pp. 1331-1334
-
-
Wysowski, D.K.1
Farinas, E.2
Swartz, L.3
-
62
-
-
0036237664
-
Abuse, dependence, or withdrawal associated with tramadol
-
Brinker A, Bonnel R, Beitz J. Abuse, dependence, or withdrawal associated with tramadol. Am J Psychiatry 2003; 159: 881.
-
(2003)
Am J Psychiatry
, vol.159
, pp. 881
-
-
Brinker, A.1
Bonnel, R.2
Beitz, J.3
-
63
-
-
0036234590
-
Clozapine and venous thromboembolism
-
Kortepeter C, Chen M, Knudsen JF, Dubitsky GM, Ahmad SR, Beitz J. Clozapine and venous thromboembolism. Am J Psychiatry 2002; 159: 876-7.
-
(2002)
Am J Psychiatry
, vol.159
, pp. 876-877
-
-
Kortepeter, C.1
Chen, M.2
Knudsen, J.F.3
Dubitsky, G.M.4
Ahmad, S.R.5
Beitz, J.6
-
65
-
-
0037075262
-
Cerivastatin and reports of fatal rhabdomyolysis
-
Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis. N Engl J Med 2002; 346: 539-40.
-
(2002)
N Engl J Med
, vol.346
, pp. 539-540
-
-
Staffa, J.A.1
Chang, J.2
Green, L.3
-
66
-
-
0036307462
-
A data mining approach for signal detection and analysis
-
Bate A, Lindquist M, Edwards IR, Orre R. A data mining approach for signal detection and analysis. Drug Saf 2002; 25: 393-7.
-
(2002)
Drug Saf
, vol.25
, pp. 393-397
-
-
Bate, A.1
Lindquist, M.2
Edwards, I.R.3
Orre, R.4
-
67
-
-
0036300732
-
Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
-
Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf 2002; 25: 381-92.
-
(2002)
Drug Saf
, vol.25
, pp. 381-392
-
-
Szarfman, A.1
Machado, S.G.2
O'Neill, R.T.3
-
68
-
-
0025905614
-
Spontaneous adverse drug reaction reporting vs event monitoring: a comparison
-
Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991; 84: 341-4.
-
(1991)
J R Soc Med
, vol.84
, pp. 341-344
-
-
Fletcher, A.P.1
-
69
-
-
0031709470
-
Under-reporting of adverse drug reactions: estimate based on a spontaneous reporting scheme and a sentinel system
-
Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Arias LH. Under-reporting of adverse drug reactions: estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 1988; 54: 483-8.
-
(1988)
Eur J Clin Pharmacol
, vol.54
, pp. 483-488
-
-
Alvarez-Requejo, A.1
Carvajal, A.2
Begaud, B.3
Moride, Y.4
Vega, T.5
Arias, L.H.6
-
70
-
-
0020373898
-
The detection of adverse reactions to therapeutic drugs
-
Finney DJ. The detection of adverse reactions to therapeutic drugs. Stat Med 1982; 1: 153-61.
-
(1982)
Stat Med
, vol.1
, pp. 153-161
-
-
Finney, D.J.1
-
71
-
-
0025334908
-
Pharmacoepidemiology: current status, prospects, and problems
-
Strom BL, Tugwell P. Pharmacoepidemiology: current status, prospects, and problems. Ann Intern Med 1990; 113: 179-81.
-
(1990)
Ann Intern Med
, vol.113
, pp. 179-181
-
-
Strom, B.L.1
Tugwell, P.2
-
72
-
-
0014972035
-
Statistical aspects of monitoring for dangers in drug therapy
-
Finney DJ. Statistical aspects of monitoring for dangers in drug therapy. Methods Inf Med 1972; 10: 1-8.
-
(1972)
Methods Inf Med
, vol.10
, pp. 1-8
-
-
Finney, D.J.1
-
73
-
-
0025075173
-
Standardization of definitions and criteria of causality assessment of adverse drug reactions: drug-induced liver disorders: report of an international consensus meeting
-
Standardization of definitions and criteria of causality assessment of adverse drug reactions: drug-induced liver disorders: report of an international consensus meeting. Int J Clin Pharmacol Ther Toxicol 1990; 28: 317-22.
-
(1990)
Int J Clin Pharmacol Ther Toxicol
, vol.28
, pp. 317-322
-
-
-
74
-
-
0027339955
-
Does proof of causality ever exist in pharmacovigilance?
-
Auriche M, Loupi E. Does proof of causality ever exist in pharmacovigilance? Drug Saf 1993; 9: 230-5.
-
(1993)
Drug Saf
, vol.9
, pp. 230-235
-
-
Auriche, M.1
Loupi, E.2
-
75
-
-
0028072358
-
False-positives in spontaneous reporting: should we worry about them?
-
Begaud B, Moride Y, Tubert-Bitter P, Chaslerie A, Haramburu F. False-positives in spontaneous reporting: should we worry about them? Br J Clin Pharmacol 1994; 38: 401-4.
-
(1994)
Br J Clin Pharmacol
, vol.38
, pp. 401-404
-
-
Begaud, B.1
Moride, Y.2
Tubert-Bitter, P.3
Chaslerie, A.4
Haramburu, F.5
-
77
-
-
0028893733
-
Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994
-
Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994. J R College Physicians Lond 1995; 29: 41-9.
-
(1995)
J R College Physicians Lond
, vol.29
, pp. 41-49
-
-
Rawlins, M.D.1
-
78
-
-
0031472193
-
Causal or casual? The role of causality assessment in pharmacovigilance
-
Meyboom RH, Hekster YA, Egberts AC, Gribnau FW, Edwards IR. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 1997; 17: 374-89.
-
(1997)
Drug Saf
, vol.17
, pp. 374-389
-
-
Meyboom, R.H.1
Hekster, Y.A.2
Egberts, A.C.3
Gribnau, F.W.4
Edwards, I.R.5
-
80
-
-
0007744281
-
Pre-existing conditions, placebo reactions, and "side effects."
-
Green DM. Pre-existing conditions, placebo reactions, and "side effects." Ann Intern Med 1964; 60: 255-65.
-
(1964)
Ann Intern Med
, vol.60
, pp. 255-265
-
-
Green, D.M.1
-
82
-
-
0017081373
-
Adverse drug reactions-a matter of opinion
-
Karch FE, Smith CL, Kerzner B, Mazzullo JM, Weintraub M, Lasagna L. Adverse drug reactions-a matter of opinion. Clin Pharmacol Ther 1976; 19: 489-92.
-
(1976)
Clin Pharmacol Ther
, vol.19
, pp. 489-492
-
-
Karch, F.E.1
Smith, C.L.2
Kerzner, B.3
Mazzullo, J.M.4
Weintraub, M.5
Lasagna, L.6
-
83
-
-
0023764134
-
Physician knowledge, attitudes, and behavior related to reporting adverse drug events
-
Rogers AS, Israel E, Smith CR. Physician knowledge, attitudes, and behavior related to reporting adverse drug events. Arch Intern Med 1988; 148: 1589-92.
-
(1988)
Arch Intern Med
, vol.148
, pp. 1589-1592
-
-
Rogers, A.S.1
Israel, E.2
Smith, C.R.3
-
84
-
-
0023372821
-
Rhode Island physicians' recognition and reporting of adverse drug reactions
-
Scott HD, Rosenbaum SE, Waters WJ, Colt AM, Andrews LG, Juergens JP et al. Rhode Island physicians' recognition and reporting of adverse drug reactions. R I Med J 1987; 70: 311-16.
-
(1987)
R I Med J
, vol.70
, pp. 311-316
-
-
Scott, H.D.1
Rosenbaum, S.E.2
Waters, W.J.3
Colt, A.M.4
Andrews, L.G.5
Juergens, J.P.6
-
85
-
-
0032417803
-
Limitations and strengths of spontaneous reports data
-
Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998; 20 (suppl C): C40-4.
-
(1998)
Clin Ther
, vol.20
, Issue.SUPPL. C
-
-
Goldman, S.A.1
-
86
-
-
0023058663
-
An evaluation of spontaneous adverse drug reaction monitoring systems
-
Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reaction monitoring systems. Am J Med 1986; 81 (suppl 5B): 49-55.
-
(1986)
Am J Med
, vol.81
, Issue.SUPPL. 5
, pp. 49-55
-
-
Sachs, R.M.1
Bortnichak, E.A.2
-
87
-
-
61449231913
-
The effects of media publicity on spontaneous adverse reaction reporting with mefloquine in the UK
-
Bhasin S, Reyburn H, Steen J, Waller PC. The effects of media publicity on spontaneous adverse reaction reporting with mefloquine in the UK. Pharmacoepidemiol Drug Saf 1997; 6 (suppl 2): 32.
-
(1997)
Pharmacoepidemiol Drug Saf
, vol.6
, Issue.SUPPL. 2
, pp. 32
-
-
Bhasin, S.1
Reyburn, H.2
Steen, J.3
Waller, P.C.4
-
88
-
-
0023142644
-
Ulcerogenicity of piroxicam: analysis of spontaneously reported data
-
Rossi AC, Hsu JP, Faich GA. Ulcerogenicity of piroxicam: analysis of spontaneously reported data. BMJ 1987; 294: 147-50.
-
(1987)
BMJ
, vol.294
, pp. 147-150
-
-
Rossi, A.C.1
Hsu, J.P.2
Faich, G.A.3
-
89
-
-
0028952828
-
Comparing reporting rates of adverse events between drugs with adjustment for year of marketing and secular trends in total reporting
-
Tsong Y. Comparing reporting rates of adverse events between drugs with adjustment for year of marketing and secular trends in total reporting. J Biopharm Stat 1995; 5: 95-114.
-
(1995)
J Biopharm Stat
, vol.5
, pp. 95-114
-
-
Tsong, Y.1
-
90
-
-
0002656565
-
Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs
-
Rainsford KD, Velo GP, eds, New York: Raven
-
Weber JCP. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. In: Rainsford KD, Velo GP, eds, Advances in Information Research, vol. 6. New York: Raven, 1984; pp. 1-7.
-
(1984)
, vol.6
, pp. 1-7
-
-
Weber, J.C.P.1
-
91
-
-
0023516052
-
Drug utilization study methodologies: national and international perspectives
-
Serradell J, Bjornson DC, Hartzema AG. Drug utilization study methodologies: national and international perspectives. Drug Intell Clin Pharm 1987; 21: 994-1001.
-
(1987)
Drug Intell Clin Pharm
, vol.21
, pp. 994-1001
-
-
Serradell, J.1
Bjornson, D.C.2
Hartzema, A.G.3
|