Prevalence of undiagnosed hypothyroidism in Europe: a systematic review and meta-analysis
Mendes D, Alves C, Silverio N, Batel Marques F
European Thyroid Journal doi: 10.1159/000499751
2019
Intensive safety monitoring program of antineoplastic medicines: a pilot study in a Portuguese oncology hospital
Mendes D, Rigueiro G, Silva R, Penedones A, Alves C, Sousa G, Batel Marques F
Journal of Oncology Pharmacy Practice
2019
Drug-induced hypersensitivity: a 5-year retrospective study in a hospital electronic health records database
Mendes D, Alves C, Loureiro M, Fonte A, Batel Marques F
Journal of Clinical Pharmacy and Therapeutics
2018
Methodologic assessment of the systematic reviews of ophthalmic adverse drug reactions published in Ophthalmology journals: a systematic review
Penedones A, Batel-Marques F
PURPOSE:
This systematic review aims to characterize and review the methodology of the systematic reviews reporting ophthalmic adverse drug reactions.
METHODS:
This systematic review followed the Cochrane Collaboration and the Preferred Reporting Items for Systematic Reviews and Meta-analyses guide. MEDLINE and EMBASE databases were searched, by all Ophthalmology journals. All systematic reviews reporting ophthalmic adverse drug reactions in the last decade were included. Data on methodology were extracted. Methodological quality was assessed through A MeaSurement Tool to Assess systematic Reviews 2 scale. Descriptive analysis was performed.
RESULTS:
Twenty-one systematic reviews were identified. Almost 60% of the systematic reviews reported non-ophthalmic drugs. Nine (43%) systematic reviews did not follow any recommendation. A search filter was not applied in 48% systematic reviews. Observational data was the source of information most included. The methodological quality was assessed in 57% systematic reviews. A meta-analysis was performed in 57% systematic reviews. The protocol’s elaboration, the explanation of the sources of information and the list of excluded articles were the domains less performed in the systematic reviews.
CONCLUSION:
The systematic reviews reporting ophthalmic adverse drug reactions diverged in some methodological aspects. Such an issue deserves further investigation, since discrepancies may lead to biased conclusions and, consequently, impact clinical and/or regulatory decisions.
Ophthalmic Res. 2018;60(2):55-68. doi: 10.1159/000489932.
2018
https://www.ncbi.nlm.nih.gov/pubmed/29975961
Da Monitorização da Segurança dos Medicamentos para a Monitorização da Segurança dos Doentes: Um Eixo Estratégico para a Atividade dos Farmacêuticos
Batel Marques F
Revista Portuguesa de Farmacoterapia. Out 2017; 9(4):51-54.
2017
http://revista.farmacoterapia.pt/index.php/rpf/article/view/166
Number needed to treat (NNT) in clinical literature: an appraisal
Mendes D, Alves C, Batel Marques F
BMC Medicine 2017;15:112. DOI: 10.1186/s12916-017-0875-8
2017
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0875-8
Benefit-risk of therapies for relapsing-remitting multiple sclerosis: testing the Number Needed to Treat to Benefit (NNTB), Number Needed to Treat Harm (NNTH) and the likelihood to be helped or harmed (LHH): a systematic review and meta-analysis.
Mendes D, Alves C, Batel Marques F.
CNS Drugs. 2016 Oct;30(10):909-29. doi:10.1007/s40263-016-0377-9.
2016
http://link.springer.com/article/10.1007%2Fs40263-016-0377-9
A systematic review of observational studies evaluating costs of adverse drug reactions.
Batel Marques F, Penedones A, Mendes D, Alves C.
Clinicoecon Outcomes Res. 2016 Aug 24;8:413-26. doi:10.2147/CEOR.S115689.
2016
https://www.dovepress.com/a-systematic-review-of-observational-studies-evaluating-costs-of-adver-peer-reviewed-article-CEOR
Outcomes from the first 6 years of operation of the Central Portugal Pharmacovigilance Unit.
Batel Marques F, Penedones A, Mendes D, Alves C.
J Patient Saf. 2016 Dec 16. doi:10.1097/PTS.0000000000000273.
2016
http://pt.wkhealth.com/pt/re/lwwgateway/landingpage.htm;jsessionid=Ym2Q62vBJj17YlTnBZThzl2tzsCQTr1hSVXnpct56By06TNTfRKx!1080955772!181195628!8091!-1?sid=WKPTLP:landingpage&an=01209203-900000000-99555
Testing the usefulness of the number needed to treat to be harmed (NNTH) in benefit-risk evaluations: case study with medicines withdrawn from the European market due to safety reasons.
Mendes D, Alves C, Batel Marques F.
OBJECTIVE:
To explore the usefulness of number needed to treat to be harmed (NNTH), in benefit-risk assessments, by studying the agreement between NNTH values and withdrawals of medicines from European market due to safety reasons.
METHODS:
Medicines with data from longitudinal studies were included. Studies were identified from European Medicines Agency’s Reports. Meta-analyses were performed to pool odds ratios (OR) with 95% confidence-intervals (CI). Published control event rates were applied to ORs to calculate NNTHs (95%CI) for selected adverse events.
RESULTS:
NNTH (95%CI) decreased from pre- to post-marketing for the eight medicines included: peripheral neuropathy (∞ vs. 12[non-significant; NS] with almitrine; heart valve disease with benfluorex (∞ vs. NNTH ranging from 7[4-13] to 7[5-9]); myopathy (-4096[NS] vs. 797[421-1690]), new-onset diabetes (113[NS] vs. 390[425-778]), bleeding (∞ vs. 517[317-1153]), and infection (∞ vs. 253[164-463]) with niacin-laropiprant; psychiatric disorders (12[7-34] vs. 9[5-24]) with rimonabant; myocardial infarction (MI) [-1305 vs. 270[89-4362]) with rofecoxib; MI (-510 vs. NNTH ranging from 152[55-4003] to 568[344-1350]) with rosiglitazone; cardiovascular events (∞ vs. 245[129-1318]) with sibutramine; and liver injury (∞ vs. 5957[NS]) with ximelagatran.
CONCLUSION:
NNTH have potential of use as a supportive tool in benefit-risk re-evaluations of medicines and may help regulators to making decisions on drug safety.
Expert Opin Drug Saf. 2016 Jul 28;15(10):1301-12. doi: 10.1080/14740338.2016.1217989
2016
http://www.ncbi.nlm.nih.gov/pubmed/27467204
A systematic review and meta-analysis of the association between systemic fluoroquinolones and retinal detachment.
Carlos Alves, Ana Penedones, Diogo Mendes and Francisco Batel Marques
Acta Ophthalmol. 2016 Feb 5. doi: 10.1111/aos.12931.
2016
http://onlinelibrary.wiley.com/doi/10.1111/aos.12931/abstract;jsessionid=0857755765BEDB9128402C8C786E8567.f01t02
Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone
Mendes D, Alves C, Batel Marques F
Pharmacoepidemiol Drug Saf. 2015 Sep 16. doi: 10.1002/pds.3874.
2015
http://www.ncbi.nlm.nih.gov/pubmed/26376779
The role of Disproportionality Analysis of Pharmacovigilance Databases in Safety Regulatory Actions: a Systematic Review
Dias P, Penedones A, Alves C, Fontes Ribeiro C, Batel Marques F
Current Drug Saf. 2015, 10(2): 000-000
2015
http://www.ncbi.nlm.nih.gov/pubmed/?term=The+role+of+Disproportionality+Analysis+of+Pharmacovigilance+Databases+in+Safety+Regulatory+Actions%3A+a+Systematic+Review
Pharmacovigilance in Portugal: Activity of the Central Pharmacovigilance Unit
Batel Marques F, Mendes D, Alves C, Penedones A, Dias P, Martins A, Santiago LM, Fontes-Ribeiro C, Caramona M, Macedo T
Acta Med Port 2015 Mar-Apr; 28(2):222-232
2015
http://www.ncbi.nlm.nih.gov/pubmed/?term=Pharmacovigilance+in+Portugal%3A+Activity+of+the+Central+Pharmacovigilance+Unit
Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade
Penedones A, Mendes D, Alves C, Batel Marques F
J Ocul Pharmacol Ther. 2015 Jun;31(5):258-68.
2015
http://www.ncbi.nlm.nih.gov/pubmed/25871404
Segurança dos Medicamentos Biológicos Oftálmicos: Revisão Sistemática
Penedones A, Mendes D, Alves C, Batel Marques F
Rev Port Farmacoter 2015; 7: 28-44
2015
Medidas de desproporcionalidade na deteção de sinal em farmacovigilância
Dias P, Fontes Ribeiro C, Batel Marques F
Revista Portuguesa de Farmacoterapia 2014; 6: 31-35
2014
Safety monitoring of ophthalmic biologics: analysis of pre and post-marketing safety data.
Penedones A, Mendes D, Alves C, Batel Marques F.
Journal of Ocular Pharmacology and Therapeutics. 2014 doi:10.1089/jop.2013.0206
2014
http://www.ncbi.nlm.nih.gov/pubmed/25073069
Drug-safety alerts issued by regulatory authorities: usefulness of meta-analysis in predicting earlier risks
Carlos Alves, Francisco Batel Marques, Ana Filipa Macedo
European Journal of Clinical Pharmacology 2014. DOI:10.1007/s00228-014-1670-5
2014
Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events.
Diogo Mendes, Carlos Alves, Francisco Batel Marques
Journal of Clinical Pharmacy and Therapeutics 2014. DOI: 10.1111/jcpt.12148
2014
