Format
Sort by
Items per page

Send to

Choose Destination

Search results

Items: 1 to 50 of 70

1.

Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?

Pacurariu AC, Hoeve CE, Arlett P, Genov G, Slattery J, Sturkenboom MCJM, Straus SMJM.

Pharmacoepidemiol Drug Saf. 2018 Feb;27(2):168-173. doi: 10.1002/pds.4359. Epub 2017 Dec 26.

PMID:
29278866
2.

Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs.

Mazzaglia G, Straus SMJ, Arlett P, da Silva D, Janssen H, Raine J, Alteri E.

Drug Saf. 2018 Feb;41(2):191-202. doi: 10.1007/s40264-017-0604-4.

3.

Baseline incidence of intussusception in early childhood before rotavirus vaccine introduction, the Netherlands, January 2008 to December 2012.

Gadroen K, Kemmeren JM, Bruijning-Verhagen PC, Straus SM, Weibel D, de Melker HE, Sturkenboom MC.

Euro Surveill. 2017 Jun 22;22(25). pii: 30556. doi: 10.2807/1560-7917.ES.2017.22.25.30556.

4.

Decision making in drug safety-a literature review of criteria used to prioritize newly detected safety issues.

Pacurariu AC, Coloma PM, Gross-Martirosyan L, Sturkenboom MC, Straus SM.

Pharmacoepidemiol Drug Saf. 2017 Mar;26(3):327-334. doi: 10.1002/pds.4128. Epub 2016 Nov 23. Review.

PMID:
27878889
5.

Using Prescription Patterns in Primary Care to Derive New Quality Indicators for Childhood Community Antibiotic Prescribing.

de Bie S, Kaguelidou F, Verhamme KM, De Ridder M, Picelli G, Straus SM, Giaquinto C, Stricker BH, Bielicki J, Sharland M, Sturkenboom MC; ARPEC study.

Pediatr Infect Dis J. 2016 Dec;35(12):1317-1323.

PMID:
27626915
6.

Patterns of spontaneous reports on narcolepsy following administration of pandemic influenza vaccine; a case series of individual case safety reports in Eudravigilance.

Gadroen K, Straus SMJM, Pacurariu A, Weibel D, Kurz X, Sturkenboom MCJM.

Vaccine. 2016 Sep 22;34(41):4892-4897. doi: 10.1016/j.vaccine.2016.08.062. Epub 2016 Aug 28.

PMID:
27577558
7.

The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study.

Vermeer NS, Ebbers HC, Straus SM, Leufkens HG, Egberts TC, De Bruin ML.

Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):297-306. doi: 10.1002/pds.3929. Epub 2015 Dec 16.

PMID:
26676881
8.

Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.

Pacurariu AC, Straus SM, Trifirò G, Schuemie MJ, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Pedersen L, Arlett P, van der Lei J, Sturkenboom MC, Coloma PM.

Drug Saf. 2015 Dec;38(12):1201-10. doi: 10.1007/s40264-015-0341-5.

9.

Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximab.

Vermeer NS, Straus SM, Mantel-Teeuwisse AK, Hidalgo-Simon A, Egberts AC, Leufkens HG, De Bruin ML.

Clin Pharmacol Ther. 2015 Nov;98(5):542-50. doi: 10.1002/cpt.207. Epub 2015 Sep 8.

PMID:
26347128
10.

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy.

Segec A, Keller-Stanislawski B, Vermeer NS, Macchiarulo C, Straus SM, Hidalgo-Simon A, De Bruin ML.

Clin Pharmacol Ther. 2015 Nov;98(5):502-5. doi: 10.1002/cpt.199. Epub 2015 Sep 11. Review.

PMID:
26250806
11.

Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project.

de Bie S, Ferrajolo C, Straus SM, Verhamme KM, Bonhoeffer J, Wong IC, Sturkenboom MC; GRiP network.

PLoS One. 2015 Jun 19;10(6):e0130399. doi: 10.1371/journal.pone.0130399. eCollection 2015.

12.

The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.

de Bie S, Coloma PM, Ferrajolo C, Verhamme KM, Trifirò G, Schuemie MJ, Straus SM, Gini R, Herings R, Mazzaglia G, Picelli G, Ghirardi A, Pedersen L, Stricker BH, van der Lei J, Sturkenboom MC; EU-ADR consortium.

Br J Clin Pharmacol. 2015 Aug;80(2):304-14. doi: 10.1111/bcp.12610. Epub 2015 May 20.

13.

Understanding drug preferences, different perspectives.

Mol PG, Arnardottir AH, Straus SM, de Graeff PA, Haaijer-Ruskamp FM, Quik EH, Krabbe PF, Denig P.

Br J Clin Pharmacol. 2015 Jun;79(6):978-87. doi: 10.1111/bcp.12566.

14.

A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.

Pacurariu AC, Coloma PM, van Haren A, Genov G, Sturkenboom MC, Straus SM.

Drug Saf. 2014 Dec;37(12):1059-66. doi: 10.1007/s40264-014-0240-1.

PMID:
25398646
15.

Isotretinoin exposure during pregnancy: a population-based study in The Netherlands.

Zomerdijk IM, Ruiter R, Houweling LM, Herings RM, Sturkenboom MC, Straus SM, Stricker BH.

BMJ Open. 2014 Nov 12;4(11):e005602. doi: 10.1136/bmjopen-2014-005602.

16.

Traceability of biologicals: present challenges in pharmacovigilance.

Vermeer NS, Spierings I, Mantel-Teeuwisse AK, Straus SM, Giezen TJ, Leufkens HG, Egberts TC, De Bruin ML.

Expert Opin Drug Saf. 2015 Jan;14(1):63-72. doi: 10.1517/14740338.2015.972362. Epub 2014 Nov 5. Review.

PMID:
25369769
17.

Dispensing of potentially teratogenic drugs before conception and during pregnancy: a population-based study.

Zomerdijk IM, Ruiter R, Houweling LM, Herings RM, Straus SM, Stricker BH.

BJOG. 2015 Jul;122(8):1119-29. doi: 10.1111/1471-0528.13128. Epub 2014 Oct 15.

18.

Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe.

Vermeer NS, Duijnhoven RG, Straus SM, Mantel-Teeuwisse AK, Arlett PR, Egberts AC, Leufkens HG, De Bruin ML.

Clin Pharmacol Ther. 2014 Dec;96(6):723-31. doi: 10.1038/clpt.2014.184. Epub 2014 Sep 15.

PMID:
25222619
19.

Long-term use of 5α-reductase inhibitors and the risk of male breast cancer.

Duijnhoven RG, Straus SM, Souverein PC, de Boer A, Bosch JL, Hoes AW, De Bruin ML.

Cancer Causes Control. 2014 Nov;25(11):1577-82. doi: 10.1007/s10552-014-0455-6. Epub 2014 Aug 19.

PMID:
25135615
20.

Risk of hyponatremia with diuretics: chlorthalidone versus hydrochlorothiazide.

van Blijderveen JC, Straus SM, Rodenburg EM, Zietse R, Stricker BH, Sturkenboom MC, Verhamme KM.

Am J Med. 2014 Aug;127(8):763-71. doi: 10.1016/j.amjmed.2014.04.014. Epub 2014 May 5.

PMID:
24811554
21.

Adherence to renal function monitoring guidelines in patients starting antihypertensive therapy with diuretics and RAAS inhibitors: a retrospective cohort study.

van Blijderveen JC, Straus SM, de Ridder MA, Stricker BH, Sturkenboom MC, Verhamme KM.

Drug Saf. 2014 May;37(5):369-77. doi: 10.1007/s40264-014-0160-0.

PMID:
24748427
22.

A population-based study on the prevalence and incidence of chronic kidney disease in the Netherlands.

van Blijderveen JC, Straus SM, Zietse R, Stricker BH, Sturkenboom MC, Verhamme KM.

Int Urol Nephrol. 2014 Mar;46(3):583-92. doi: 10.1007/s11255-013-0563-3. Epub 2013 Sep 27.

PMID:
24072454
23.

Post-approval safety issues with innovative drugs: a European cohort study.

Mol PG, Arnardottir AH, Motola D, Vrijlandt PJ, Duijnhoven RG, Haaijer-Ruskamp FM, de Graeff PA, Denig P, Straus SM.

Drug Saf. 2013 Nov;36(11):1105-15. doi: 10.1007/s40264-013-0094-y.

PMID:
24048690
24.

Additional risk minimisation measures in the EU - are they eligible for assessment?

Zomerdijk IM, Trifirò G, Sayed-Tabatabaei FA, Sturkenboom MC, Straus SM.

Pharmacoepidemiol Drug Saf. 2013 Oct;22(10):1046-53. doi: 10.1002/pds.3494. Epub 2013 Aug 15.

PMID:
23946274
25.

Overanticoagulation is associated with renal function decline.

van Blijderveen JC, Verhamme KM, Zietse R, Visser LE, Romio SA, Buhre PN, Sturkenboom MC, Hofman A, Straus SM, Stricker BH.

J Nephrol. 2013 Jul-Aug;26(4):691-8. doi: 10.5301/jn.5000280. Epub 2013 Jul 1.

PMID:
23843045
26.

The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.

Piening S, de Graeff PA, Straus SM, Haaijer-Ruskamp FM, Mol PG.

Drug Saf. 2013 Sep;36(9):723-31. doi: 10.1007/s40264-013-0079-x.

PMID:
23797603
27.

Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.

Vermeer NS, Straus SM, Mantel-Teeuwisse AK, Domergue F, Egberts TC, Leufkens HG, De Bruin ML.

Drug Saf. 2013 Aug;36(8):617-25. doi: 10.1007/s40264-013-0073-3.

PMID:
23771794
28.

Number of patients studied prior to approval of new medicines: a database analysis.

Duijnhoven RG, Straus SM, Raine JM, de Boer A, Hoes AW, De Bruin ML.

PLoS Med. 2013;10(3):e1001407. doi: 10.1371/journal.pmed.1001407. Epub 2013 Mar 19.

29.

When direct health-care professional communications have an impact on inappropriate and unsafe use of medicines.

Reber KC, Piening S, Wieringa JE, Straus SM, Raine JM, de Graeff PA, Haaijer-Ruskamp FM, Mol PG.

Clin Pharmacol Ther. 2013 Apr;93(4):360-5. doi: 10.1038/clpt.2012.262. Epub 2012 Dec 27.

PMID:
23443752
30.

Healthcare professionals' self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands.

Piening S, Haaijer-Ruskamp FM, de Graeff PA, Straus SM, Mol PG.

Drug Saf. 2012 Nov 1;35(11):1061-72. doi: 10.2165/11635750-000000000-00000.

PMID:
23061782
31.

Reasons for and time to discontinuation of rimonabant therapy: a modified prescription-event monitoring study.

Willemen MJ, Mantel-Teeuwisse AK, Buggy Y, Layton D, Straus SM, Leufkens HG, Egberts TC.

Drug Saf. 2012 Dec 1;35(12):1147-58. doi: 10.2165/11631330-000000000-00000.

PMID:
23061737
32.

Rituximab-induced thrombocytopenia: a cohort study.

Giezen TJ, Mantel-Teeuwisse AK, ten Berg MJ, Straus SM, Leufkens HG, van Solinge WW, Egberts TC.

Eur J Haematol. 2012 Sep;89(3):256-66. doi: 10.1111/j.1600-0609.2012.01808.x. Epub 2012 Jul 5.

PMID:
22639923
33.

Prescribing of rosiglitazone and pioglitazone following safety signals: analysis of trends in dispensing patterns in the Netherlands from 1998 to 2008.

Ruiter R, Visser LE, van Herk-Sukel MP, Geelhoed-Duijvestijn PH, de Bie S, Straus SM, Mol PG, Romio SA, Herings RM, Stricker BH.

Drug Saf. 2012 Jun 1;35(6):471-80. doi: 10.2165/11596950-000000000-00000.

PMID:
22540371
34.

Concomitant use of contraceptives and potentially teratogenic medicinal products--results from a study using pharmacy dispensing data in the Netherlands.

Ruiter R, Teichert M, Straus SM, Stricker BH, Visser LE.

Reprod Sci. 2012 Sep;19(9):987-94. doi: 10.1177/1933719112440050. Epub 2012 Apr 23.

PMID:
22527986
35.

Impact of safety-related regulatory action on clinical practice: a systematic review.

Piening S, Haaijer-Ruskamp FM, de Vries JT, van der Elst ME, de Graeff PA, Straus SM, Mol PG.

Drug Saf. 2012 May 1;35(5):373-85. doi: 10.2165/11599100-000000000-00000. Review.

PMID:
22480319
36.

Impact of safety-related regulatory action on drug use in ambulatory care in the Netherlands.

Piening S, Reber KC, Wieringa JE, Straus SM, de Graeff PA, Haaijer-Ruskamp FM, Mol PG.

Clin Pharmacol Ther. 2012 May;91(5):838-45. doi: 10.1038/clpt.2011.308.

PMID:
22472991
37.

Vaccine-based subgroup analysis in VigiBase: effect on sensitivity in paediatric signal detection.

de Bie S, Verhamme KM, Straus SM, Stricker BH, Sturkenboom MC.

Drug Saf. 2012 Apr 1;35(4):335-46. doi: 10.2165/11598120-000000000-00000.

PMID:
22435344
38.

Risk minimization activities of centrally authorized products in the EU: a descriptive study.

Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, Blackburn SC, Sturkenboom MC, Straus SM.

Drug Saf. 2012 Apr 1;35(4):299-314. doi: 10.2165/11594560-000000000-00000.

PMID:
22339506
39.

Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study.

Crijns HJ, van Rein N, Gispen-de Wied CC, Straus SM, de Jong-van den Berg LT.

Pharmacoepidemiol Drug Saf. 2012 Oct;21(10):1060-6. doi: 10.1002/pds.3200. Epub 2012 Jan 6.

PMID:
22228673
40.

Lower risk of cancer in patients on metformin in comparison with those on sulfonylurea derivatives: results from a large population-based follow-up study.

Ruiter R, Visser LE, van Herk-Sukel MP, Coebergh JW, Haak HR, Geelhoed-Duijvestijn PH, Straus SM, Herings RM, Stricker BH.

Diabetes Care. 2012 Jan;35(1):119-24. doi: 10.2337/dc11-0857. Epub 2011 Nov 18.

41.

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, de Graeff PA, Mol PG.

Drug Saf. 2011 Nov 1;34(11):1101-14. doi: 10.2165/11592060-000000000-00000.

PMID:
21981437
42.

Risk of cancer in patients on insulin glargine and other insulin analogues in comparison with those on human insulin: results from a large population-based follow-up study.

Ruiter R, Visser LE, van Herk-Sukel MP, Coebergh JW, Haak HR, Geelhoed-Duijvestijn PH, Straus SM, Herings RM, Stricker BH.

Diabetologia. 2012 Jan;55(1):51-62. doi: 10.1007/s00125-011-2312-4. Epub 2011 Sep 29.

43.

The distribution of congenital anomalies within the VACTERL association among tumor necrosis factor antagonist-exposed pregnancies is similar to the general population.

Crijns HJ, Jentink J, Garne E, Gispen-de Wied CC, Straus SM, de Jong-van den Berg LT; EUROCAT Working Group.

J Rheumatol. 2011 Sep;38(9):1871-4. doi: 10.3899/jrheum.101316. Epub 2011 Jul 1.

PMID:
21724702
44.

Additional safety risk to exceptionally approved drugs in Europe?

Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, Eichler HG, de Graeff PA, Mol PG.

Br J Clin Pharmacol. 2011 Sep;72(3):490-9. doi: 10.1111/j.1365-2125.2011.03995.x.

45.

Use of dipeptidyl peptidase-4 inhibitors and the reporting of infections: a disproportionality analysis in the World Health Organization VigiBase.

Willemen MJ, Mantel-Teeuwisse AK, Straus SM, Meyboom RH, Egberts TC, Leufkens HG.

Diabetes Care. 2011 Feb;34(2):369-74. doi: 10.2337/dc10-1771.

46.

Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase.

Giezen TJ, Mantel-Teeuwisse AK, Meyboom RH, Straus SM, Leufkens HG, Egberts TC.

Drug Saf. 2010 Oct 1;33(10):865-78. doi: 10.2165/11538330-000000000-00000.

PMID:
20812771
47.

Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review.

Crijns HJ, Straus SM, Gispen-de Wied C, de Jong-van den Berg LT.

Br J Dermatol. 2011 Feb;164(2):238-44. doi: 10.1111/j.1365-2133.2010.09976.x. Review.

PMID:
20716214
48.

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

Mol PG, Straus SM, Piening S, de Vries JT, de Graeff PA, Haaijer-Ruskamp FM.

Drug Saf. 2010 Jun 1;33(6):463-74. doi: 10.2165/11532840-000000000-00000.

PMID:
20486729
49.

Non-cardiovascular drugs that inhibit hERG-encoded potassium channels and risk of sudden cardiac death.

van Noord C, Sturkenboom MC, Straus SM, Witteman JC, Stricker BH.

Heart. 2011 Feb;97(3):215-20. doi: 10.1136/hrt.2009.188367. Epub 2010 Apr 20.

PMID:
20406763
50.

Isotretinoin use and compliance with the Dutch Pregnancy Prevention Programme: a retrospective cohort study in females of reproductive age using pharmacy dispensing data.

Teichert M, Visser LE, Dufour M, Rodenburg E, Straus SM, De Smet PA, Stricker BH.

Drug Saf. 2010 Apr 1;33(4):315-26. doi: 10.2165/11319190-000000000-00000.

PMID:
20297863

Supplemental Content

Loading ...
Support Center