scholarly journals Postmarketing surveillance of adverse events following meningococcal B vaccination: data from Apulia Region, 2014–19

2021 ◽  
pp. 1-6
Author(s):  
Pasquale Stefanizzi ◽  
Francesco Paolo Bianchi ◽  
Giuseppe Spinelli ◽  
Fabio Amoruso ◽  
Domenica Ancona ◽  
...  
Keyword(s):  
Adverse Events ◽  
Postmarketing Surveillance ◽  
Apulia Region

scholarly journals Pharmacovigilance of Sodium-Glucose Cotransporter-2 Inhibitors for Genital Fungal Infections and Urinary Tract Infections: A Review of the Food and Drug Administration Adverse Event Reporting System Database

2018 ◽  
Vol 34 (4) ◽  
pp. 144-148
Author(s):  
Hannah Mohammad ◽  
Nancy Borja-Hart
Keyword(s):  
Urinary Tract ◽  
Tract Infection ◽  
Adverse Events ◽  
Fungal Infections ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sglt2 Inhibitors ◽  
Postmarketing Surveillance ◽  
Sodium Glucose Cotransporter ◽  
Tract Infections

Background: Postmarketing surveillance had previously identified the need for revisions in the labeling of the sodium-glucose cotransporter-2 (SGLT2) inhibitors drug class related to the risk of diabetic ketoacidosis. Other adverse events have been reported. Objective: To examine postmarketing surveillance data of the SGLT2 inhibitors, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, specifically to assess prevalence of urinary tract infections (UTIs) and genital fungal infections. Methods: FAERS case reports submitted between March 2013 and November 2015 were reviewed for 6 SGLT2 inhibitors (mono and combo therapies). The Medical Dictionary for Regulatory Activities (MedDRA) was used to define preferred terms (genital fungal infections: vulvovaginal mycotic infection, vulvovaginal candidiasis, urinary tract infection fungal, and genital candidiasis; UTI: urinary tract infection, genitourinary tract infection, kidney infection, cystitis, and pyelonephritis). Word frequencies were queried using the qualitative data analysis software NVivo 11 (QSR International), and results were then individually reviewed. Results: A total of 12 581 cases were received, but 466 were excluded (total n = 12 115). A total of 348 cases related to genital fungal infections were reported (2.9% of reports submitted): dapagliflozin = 53, empagliflozin/linagliptin = 6, canagliflozin = 267, canagliflozin/metformin = 3, empagliflozin = 17, and dapagliflozin/metformin HCl ER = 2. A total of 727 cases related to UTIs were reported (6% of reports submitted): dapagliflozin = 168, empagliflozin/linagliptin = 5, canagliflozin/metformin = 8, canagliflozin = 503, empagliflozin = 38, and dapagliflozin/metformin HCl ER = 5. Conclusions: A causal relationship between SGLT2 inhibitors and the adverse events reported cannot be established due to the nature of postmarketing surveillance. However, health care providers should counsel patients about these potential adverse events.

Systematic causality assessment of adverse events following HPV vaccines: Analysis of current data from Apulia region (Italy)

Vaccine ◽  
2018 ◽  
Vol 36 (8) ◽  
pp. 1072-1077 ◽  
Author(s):  
Silvio Tafuri ◽  
Francesca Fortunato ◽  
Maria Serena Gallone ◽  
Pasquale Stefanizzi ◽  
Giulia Calabrese ◽  
...  
Keyword(s):  
Adverse Events ◽  
Causality Assessment ◽  
Current Data ◽  
Hpv Vaccines ◽  
Apulia Region

Biosimilar trastuzumab active post marketing surveillance real world 2020 data update: Results from a patient support program for patients under treatment with the first biosimilar trastuzumab approved in Brazil.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14504-e14504
Author(s):  
Allisson Monteiro da Silva ◽  
Thais Tiemi Wepeck Oliveira Watanabe ◽  
Eimy Honda ◽  
Juliana Yamaguchi
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Support Program ◽  
Surveillance Program ◽  
Postmarketing Surveillance ◽  
Patient Support ◽  
Patient Support Program ◽  
Her2 Breast Cancer ◽  
Phone Calls ◽  
Post Marketing Surveillance

e14504 Background: In 2017, biosimilar trastuzumab (Zedora) became the first biosimilar trastuzumab approved in Brazil. In May 2018 an active postmarketing surveillance program was instituted. Data from this program was presented in ASCO in 2019 and 2020. Now, with an extended follow up (May 2018 to December 2020) and more patients included, we present updated data from the surveillance program. Methods: This is a prospective observational study to evaluate data from the patient support program. Patients who received prescription for biosimilar trastuzumab were invited to participate. After agreement of informed consent, they were followed by periodical phone calls after each infusion and up to 3 months after the end of treatment. Treatment related data and adverse events (AEs) were collected. Results: A total of 74 reports containing 656 adverse events (AEs) were received from the active postmarketing surveillance program between May 2018 and December 2020. Of the 74 reports, 73 are female patients with HER2+ breast cancer (BC) and 1 is a male patient with gastric adenocarcinoma. The patients mean age was 52 years (31 to 79 years). Regarding to AEs severity and expectedness, 588 (89.63%) were non-serious AE (413 expected / 175 unexpected) and 68 (10.37%) were serious AE (51 expected / 17 unexpected). Considering all serious unexpected AEs (17), 13 were assessed as not related to trastuzumab therapy and 4 were assessed as related to therapy. For the 175 non-serious unexpected AEs, 56 were assessed as not related to therapy and 119 were assessed as related to therapy. The three most frequently reported AEs according to SOC (System Organ Classification) were general disorders and administration site conditions 111 (16.92%), gastrointestinal disorders 98 (14.93%) and nervous system disorders 88 (13.41%). The five most commonly reported adverse events (MedDRA PT - Preferred term) were diarrhea 27 (4.11%), fatigue 24 (3.66%), nausea 22 (3.35%), weight decreased 18 (2.74%) and infusion related reaction 17 (2.59%). Further monitoring is continued. Conclusions: Nature of AEs noted in patients with breast cancer and gastric cancer treated with biosimilar trastuzumab (Zedora) were consistent with the known safety profile of Trastuzumab. The risk benefit remains consistent with the reference safety information and no new safety signals were detected.[Table: see text]

POSTMARKETING SURVEILLANCE FOR NEUROLOGIC ADVERSE EVENTS REPORTED AFTER HEPATITIS B VACCINATION

1988 ◽  
Vol 127 (2) ◽  
pp. 337-352 ◽  
Author(s):  
FREDERIC E. SHAW ◽  
DAVID J. GRAHAM ◽  
HARRY A GUESS ◽  
JULIE B. MILSTIEN ◽  
JOYCE M. JOHNSON ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Adverse Events ◽  
Hepatitis B Vaccination ◽  
Postmarketing Surveillance

scholarly journals Adverse events following Men B vaccine and causality assessment: data from Apulia Region (Italy)

2018 ◽  
Vol 28 (suppl_4) ◽  
Author(s):  
P Stefanizzi ◽  
FP Bianchi ◽  
S De Nitto ◽  
V Infantino ◽  
S Tafuri
Keyword(s):  
Adverse Events ◽  
Causality Assessment ◽  
Assessment Data ◽  
Apulia Region

scholarly journals Postmarketing surveillance does not catch all adverse events

BMJ ◽  
1996 ◽  
Vol 312 (7030) ◽  
pp. 577-577 ◽  
Author(s):  
P. O'Brien
Keyword(s):  
Adverse Events ◽  
Postmarketing Surveillance

Review of postmarketing surveillance of molecular targeted anticancer agents in Japan

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6598-6598
Author(s):  
Y. Miura ◽  
M. Kami ◽  
T. Morita ◽  
M. Tsubokura ◽  
N. Takei ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Adverse Events ◽  
Anticancer Agents ◽  
Safety Profile ◽  
Performance Status ◽  
Safety Information ◽  
Mortality Rates ◽  
Gemtuzumab Ozogamicin ◽  
Postmarketing Surveillance ◽  
Related Mortality

6598 Background: Since the safety profile of molecular targeted anticancer agents is different from that of conventional anticancer agents, the safety information is limited. Although postmarketing surveillance (PMS) on safety is important, the appropriate methods of PMS have not been established. Methods: We investigated PMS methods, patients’ performance status (PS), and safety of the eight molecular targeted anticancer agents (imatinib, rituximab, trastuzumab, gefitinib, gemtuzumab ozogamicin [GO], bortezomib, bevacizumab, erlotinib) approved in Japan. We excluded sunitinib and sorafenib as the PMS of these agents were ongoing. Results: Besides PMS of gefitinib, seven PMS enrolled all the patients that received the study agents. The inclusive type of PMS was required at approval of the latest four agents, GO, bortezomib, bevacizumab, and erlotinib. The total number of enrolled patients was 8,776. Seven PMS of imatinib, rituximab, trastuzumab, GO, bortezomib, bevacizumab, and erlotinib enrolled 309, 2,575, 1,142, 316, 666, 2,698, and 1,070 patients, respectively. Data on the frequencies of patients with PS 3–4 were available in five of seven PMS, which were 7%, 7%, 20%, 3%, and 0.1% in PMS of rituximab, trastuzumab, GO, bortezomib, bevacizumab, respectively. Frequencies of severe adverse events were described in four of seven PMS, which were 3–6%, 0.3–4%, 0–45, and 0–2% in PMS of imatinib, rituximab, bortezomib, and bevacizumab, respectively. Interstitial lung disease related to Bevacizumab was unknown in premarketing studies and was observed in 0.4% in PMS. Drug related mortality rates were described in four of seven PMS, which were 1%, 8%, 3%, and 2% in PMS of rituximab, GO, bortezomib, and bevacizumab, respectively. Conclusions: Although PS varied among PMS of different molecular targeted anticancer agents, patients with poor PS were not included in most PMS. Disclosure of PMS results was insufficient. Further investigation on appropriate methods of PMS and its disclosure is warranted. No significant financial relationships to disclose.

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