Acute Hemolytic Reactions Reported in ITP Patients Treated with Rho (D) Immune Globulin: Symptom Onset and Does Prior Exposure Lessen the Risk?

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4670-4670
Author(s):  
Carmen Muller ◽  
Gregg Little ◽  
Kristen Hess ◽  
Chris Sinclair
Keyword(s):  
Immune Globulin ◽  
Symptom Onset ◽  
Reporting Rate ◽  
Prior Exposure ◽  
Retrospective Evaluation ◽  
Intravascular Hemolysis ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Marketing Data ◽  
Surveillance Database

Abstract Abstract 4670 BACKGROUND: Acute hemolytic reactions (AHR) associated with administration of Rho (D) Immune Globulin (RhIG; WinRho® SDF, Cangene Corporation, Winnipeg, Canada) have been infrequently reported during the previous 16 years. AHR were defined as any case reported with signs of hemolysis (hemoglobin decrease, haptoglobin decrease, LDH increase, elevation of bilirubin, etc.) occurring within hours to a number of days after RhIG administration irrespective of the degree of change from baseline. Intravascular hemolysis (IVH) was defined as a specific type of AHR in which plasma or urinary hemoglobin were positive. The reporting rate of AHR (including IVH) among RhIG-treated patients was previously estimated as 1/946 doses (0.11%), while the estimated reporting rate of IVH was 1/3,271 doses (0.03%).1 Reports surrounding the clinical monitoring of such patients have led to the analysis of AHR post-marketing data. AIMS/PURPOSE: Identify the onset of AHR/IVH symptoms relative to RhIG and determine if prior exposure to RhIG mitigates the risk of such events. METHODS: Retrospective evaluation of AHR (AEs reported with signs of hemolysis; including IVH) from the Cangene post-marketing surveillance database. RESULTS: CONCLUSION: Of the ITP patients who developed IVH, 40% reported an onset of symptoms within 4 hours of RhIG infusion; an additional 10% reported symptoms within 8 hours. The symptom onset was unidentified in 18% of IVH cases. In addition, previous uneventful administration of RhIG did not preclude the possibility of an occurrence of IVH and its complications following subsequent administration of RhIG; however, the majority (approx 84%) of reports of IVH were among RhIG naïve patients. Disclosures: Muller: Cangene: Employment. Little:Cangene: Employment. Hess:Cangene: Employment. Sinclair:Cangene: Employment.

scholarly journals PHARMACOVIGILANCE: DYNAMICS IN INDIAN PHARMA INDUSTRY

2018 ◽  
Vol 6 (01) ◽  
pp. 30-33
Author(s):  
Shubham Bhardwaj ◽  
Rajeshwar Verma ◽  
Romil Sharma ◽  
Rahul Solakhia
Keyword(s):  
Early Stage ◽  
Safety Issue ◽  
Safety Information ◽  
Safety Monitoring ◽  
Reporting Rate ◽  
Drug Safety Issue ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Marketing Data ◽  
Pharmaceutical Industries

Pharmacovigilance refers to the process of identifying, detecting, and responding to drug safety issue and has witnessed dynamic advancements in pharmaceutical industries throughout the world. The main objective of pharmacovigilance is to extend the safety monitoring and to detect any ADRs that previously got unrecognized in evolution during clinical trial. ADRs monitoring is required for each medicine throughout its lifecycle which includes early stage of drug design, clinical trials, and post marketing surveillance. The emerging trend in pharmacovigilance is to link the pre marketing data with the data collected during post marketing phase that include safety information. India is a vast country with population of over 1.32 Billion with different social economics status, different patterns of disease prevalence it becomes more important to have a standardized and robust pharmacovigilance. Pharmacists, as doctor remark that their involvement may increase the reporting rate and have a greater role to play in the area of pharmacovigilance

Incidence of thromboembolism in patients receiving vorinostat: Clinical trial and post-marketing data from more than 1,800 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e14547-e14547
Author(s):  
S. Rizvi ◽  
J. Lis ◽  
K. Boileau ◽  
J. Garcia-Vargas
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients ◽  
Serious Adverse Events ◽  
Cutaneous Manifestations ◽  
Post Marketing Surveillance ◽  
The Usa ◽  
Post Marketing ◽  
Marketing Data

e14547 Background: Thromboembolic events (TEEs) occur in approximately 10–15% of advanced cancer patients. Risk factors include cancer therapy and extent and type of malignancy. Vorinostat, a histone deacetylase inhibitor, has been licensed in the USA for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following two systemic therapies. TEEs were observed in 6/86 patients (7.0%) enrolled in vorinostat CTCL clinical trials at licensure. To gain further insight into the association between TEEs and vorinostat treatment, we analyzed data from vorinostat clinical trials and post-marketing surveillance (PMS) reports. Methods: Serious adverse events (SAEs) reported through November 3, 2008, among patients receiving vorinostat in completed and ongoing clinical trials, PMS reports, and published literature were reviewed for terms consistent with TEEs. A committee of independent (non-Merck employees) academic experts evaluated these reports. Although no safety signals were observed, the committee recommended that d-dimer and/or plasmin-antiplasmin assays should be conducted. This recommendation has been implemented in three ongoing studies ( NCT00486720 , NCT00632931 , NCT006429542) and will provide further information on clotting parameters among patients being treated with vorinostat. Results: During the reporting period, data from >1,845 cancer patients who received vorinostat were reviewed. Irrespective of causality, 107 patients (<5.8%) reported TEE SAEs (Table). Of these, 47 (<2.6%) had TEE SAEs that were rated as related to vorinostat, four of which were fatal. As of the data cut off, review of the special assays in the three studies did not result in any conclusive correlation. Conclusions: The incidence rate of TEEs observed in vorinostat studies is similar to reported rates of TEEs for advanced cancer patients. [Table: see text] [Table: see text]

scholarly journals Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

2021 ◽  
pp. 276-288
Author(s):  
S. Narmada ◽  
M. P. Gowrav ◽  
Akhilesh Akki ◽  
Vishakharaju Motupalli ◽  
V. Balamuralidhara ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Healthcare Providers ◽  
The United States ◽  
Reporting Rate ◽  
Global Perspective ◽  
Drug Reactions ◽  
Paediatric Patients ◽  
Post Marketing Surveillance ◽  
Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

Are Communication Tools Effective in Increasing Reporting Rate of Acute Hemolytic Reactions (AHR) In ITP Patients Treated with Rh (D) Immune Globulin?

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4677-4677
Author(s):  
Faiz Guirgis ◽  
Carmen Muller ◽  
Gregg Little ◽  
Chris Sinclair ◽  
Maurice Genereux
Keyword(s):  
Healthcare Professional ◽  
Immune Globulin ◽  
Case Series ◽  
Reporting Rate ◽  
Initial Estimate ◽  
Intravascular Hemolysis ◽  
Communication Tools ◽  
Appreciable Change ◽  
Safety Database ◽  
Reporting Frequency

Abstract Abstract 4677 BACKGROUND: Acute Hemolytic Reactions (AHR) associated with administration of Rh(D) Immune Globulin (WinRho® SDF, Cangene Corporation, Winnipeg, MB, Canada) have been infrequently reported during the last 15 years. AHR's as defined were any case reporting hemoglobin decrease, haptoglobin decrease, elevation of bilirubin occurring within hours to number ofdays after WinRho® SDF treatment irrespective of the degree of change from baseline. AHR's where plasma or urinary hemoglobin were positive were categorized as cases of Intravascular Hemolysis (IVH). AIMS/PURPOSE: To determine if communication tools such as publication of Case series (Gaines), Dear Doctor Letters and label changes stimulated reporting of AHR's and IVH. METHODS: Cangene's WinRho® SDF safety database from USA. was reviewed and analysed for the period 1995–2009. The reporting rate of AHR and IVH were calculated based on cases submitted by year and estimates of number of doses distributed in USA for ITP. These rates were trended to determine if the communication of safety risk was effective in stimulating reporting and decreasing rates of AHR or IVH cases. RESULTS: Gaines published 15 cases of IVH after WinRho® SDF in April 2000. Label changes and Dear Healthcare Professional (DHCP) letters were issued in 2000. Gaines reported 6 cases of disseminated intravascular coagulation with IVH in September 2005 and label was changed with Dear Healthcare Professional letters issued in Dec 2005. Reporting rate of IVH was not affected by these warnings. Increase in reporting rate of AHR's was seen after publications and warning letters in 2000 and 2005. CONCLUSION: The overall reporting rate of AHR (including IVH) was estimated as infrequent (0.12%) while IVH reporting frequency was rare (0.03%). Despite significant communication through FDA publications, medical education efforts and DHCP letters, there has been no appreciable change in reporting frequency of hemolytic events following Rh (D) Immune Globulin administration. This suggests that the initial estimate of IVH occurring at approximately 1:1000 doses (Gaines 2000) is still appropriate. Disclosures: Guirgis: Cangene Corporation: Employment. Muller:Cangene Corporation: Employment. Little:Cangene Corporation: Employment. Sinclair:Cangene Corporation: Employment. Genereux:Cangene Corporation: Employment.

scholarly journals Safety Profile of Recommended Vaccinations in Adolescents: Data from Surveillance of Adverse Events Following Immunization in Puglia (Italy), 2016–2020

Vaccines ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1302
Author(s):  
Antonio Di Lorenzo ◽  
Francesco Paolo Bianchi ◽  
Andrea Martinelli ◽  
Sabrina Lattanzio ◽  
Antonella Carbonara ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Causality Assessment ◽  
Real Life ◽  
Study Data ◽  
Reporting Rate ◽  
World Health ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Health Organization

Adolescence is a critical period for immunization, in which the adhesion rate to recommended vaccinations is often lower than desired. Since the safety of new vaccines is one of the most important factors determining vaccination hesitancy, post-marketing surveillance of adverse events following immunization (AEFIs) is recommended by the World Health Organization (WHO) to better understand the safety of these drugs. This report describes AEFIs notified in Puglia (Italy) after recommended vaccinations in adolescents aged 12 to 18 years in 2016–2020 to determine the safety profile of these products in a real-life scenario. This is a retrospective observational study. Data were gathered from the list of AEFIs notified in subjects between 12 and 18 years of age following administration of recommended vaccines in Puglia in 2016–2020. AEFIs were classified according to the WHO’s decisional algorithm, and causality assessment was carried out for serious AEFIs. From 2016 to 2020, 323,627 doses of vaccine were administered to adolescents in Puglia and 50 AEFIs were reported (reporting rate: 15.4 × 100,000 doses). Of these, 17 (34.0%) were classified as serious, and causality assessment identified 13 of them (76.5%) as vaccine related. The most common symptoms were local reactions, fever and neurological symptoms. No deaths were notified. The benefits of immunization in adolescents appear to be greater than the risk of AEFIs for all studied vaccines; in fact, AEFIs occur in less than 0.1‰ of patients and are generally mild and self-limiting.

EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

1983 ◽  
Vol 22 (03) ◽  
pp. 135-148 ◽  
Author(s):  
T. Kitaguchi ◽  
T. Nojiri ◽  
S. Suzuki ◽  
T. Fukita ◽  
T. Kawana
Keyword(s):  
Data Base ◽  
Clinical Case ◽  
Drug Information ◽  
Case Record ◽  
Post Marketing Surveillance ◽  
Japanese Character ◽  
Record Data ◽  
Post Marketing ◽  
On Line ◽  
Line Drug

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Term Therapy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Long Term Therapy
Sign in / Sign up

Export Citation Format

Share Document