scholarly journals Role of Pharmacovigilance in India: An overview

2015 ◽  
Vol 7 (2) ◽  
Author(s):  
Sanvidhan G Suke ◽  
Prabhat Kosta ◽  
Harsh Negi
Keyword(s):  
Clinical Trials ◽  
Safety Information ◽  
Collective Responsibility ◽  
Scientific Data ◽  
Biomedical Literature ◽  
Pv System ◽  
Spontaneous Reports ◽  
Post Marketing Surveillance ◽  
Patient Reported ◽  
Post Marketing

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication, ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due  to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, product safety PV helps to the patients get well, and to manage optimally, or ideally avoid, illness is a collective responsibility of industry, drug regulators, and clinicians and other healthcare professionals. This review summarized objectives and methodologies used in PV with critical overview of existing PV in India, challenges to overcome and future prospects with respect to Indian context.Keywords: Pharmacovigilance; Adverse drug reaction; Clinical trials; Pharmacogenomics; Data mining; Indian Pharmacopoeia Commission

An Update on the Safety and Tolerability of Pimecrolimus Cream 1%: Evidence from Clinical Trials and Post-Marketing Surveillance

Dermatology ◽  
2007 ◽  
Vol 215 (1) ◽  
pp. 27-44 ◽  
Author(s):  
Richard G.B. Langley ◽  
Thomas A. Luger ◽  
Michael J. Cork ◽  
Dirk Schneider ◽  
Carle Paul
Keyword(s):  
Clinical Trials ◽  
Post Marketing Surveillance ◽  
Post Marketing

scholarly journals Safety and reactogenicity of the adjuvanted recombinant zoster vaccine: experience from clinical trials and post-marketing surveillance

2021 ◽  
Vol 9 ◽  
pp. 251513552110574
Author(s):  
Joseph Fiore ◽  
Maribel Miranda Co-van der Mee ◽  
Andrés Maldonado ◽  
Lisa Glasser ◽  
Phil Watson
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Pooled Analysis ◽  
Cell Transplant ◽  
Zoster Vaccine ◽  
Phase 3 ◽  
Pivotal Phase ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Recombinant Zoster Vaccine

An adjuvanted recombinant zoster vaccine (RZV) is licensed for the prevention of herpes zoster. This paper reviews its safety and reactogenicity. A pooled analysis of two pivotal randomized Phase-3 trials (NCT01165177, NCT01165229) in adults ⩾50 years found that more solicited adverse events (AEs) were reported with RZV than placebo. Injection site pain was the most common solicited AE (RZV: 78.0% participants; placebo: 10.9%). Grade-3 pain occurred in 6.4% of RZV and 0.3% of placebo recipients. Myalgia, fatigue, and headache were the most commonly reported general solicited AEs (RZV: 44.7%, 44.5%, and 37.7%, respectively; placebo: 11.7%, 16.5%, and 15.5%, respectively). Most symptoms were mild to moderate in intensity with a median duration of 2–3 days. The intensity of reactogenicity symptoms did not differ substantially after the first and second vaccine doses. The pooled analysis of the pivotal Phase-3 trials did not identify any clinically relevant differences in the overall incidence of serious adverse events (SAEs), fatal AEs or potential immune-mediated diseases (pIMDs) between RZV and placebo. Reactogenicity in five studies of immunocompromised patients ⩾18 years (autologous stem cell transplant, human immunodeficiency virus, solid tumors, hematological malignancies, and renal transplant; NCT01610414, NCT01165203, NCT01798056, NCT01767467, and NCT02058589) was consistent with that observed in the pivotal Phase-3 trials. There were no clinically relevant differences between RZV and placebo in the immunocompromised populations with regard to overall incidence of SAEs, fatal AEs, pIMDs, or AEs related to patients’ underlying condition. Post-marketing surveillance found that the most commonly reported AEs were consistent with the reactogenicity profile of the vaccine in clinical trials. Overall, the clinical safety data for RZV are reassuring. [Formula: see text]

scholarly journals Insulin Glulisine in Pregnancy – Experience from Clinical Trials and Post-marketing Surveillance

2015 ◽  
Vol 11 (1) ◽  
pp. 17 ◽  
Author(s):  
Zoran Doder ◽  
Demi Vanechanos ◽  
Manfred Oster ◽  
Wolfgang Landgraf ◽  
Stephen Lin ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trials ◽  
Congenital Malformations ◽  
Safety Data ◽  
Live Births ◽  
Post Marketing Surveillance ◽  
Increased Risk ◽  
Post Marketing ◽  
Insulin Glulisine ◽  
In Pregnancy

Pregnancies complicated by gestational diabetes or pre-existing type 1 or type 2 diabetes mellitus are associated with a higher rate of adverse outcomes compared with pregnancies in the background population. These outcomes include miscarriage, pre-term delivery, pre-eclampsia, perinatal mortality and congenital malformations. Insulin glulisine (ApidraR, Sanofi) is a rapid-acting insulin analogue indicated for the treatment of adults, adolescents and children 6 years or older with diabetes mellitus where treatment with insulin is required. Here, all post-marketing and clinical trials safety data with insulin glulisine in pregnancy available to Sanofi up to June 2014 are summarised together with the findings of a comprehensive literature search. Cumulatively, a total of 303 pregnancy exposures to insulin glulisine were received. Of these 303 pregnancy exposures, there were 116 live births, 12 spontaneous abortions, two late foetal intra-uterine deaths (>28 weeks), three elective abortions and 170 cases without a known pregnancy outcome. There were six cases of congenital malformations; of these, there were five live births; in the other case a live birth was not confirmed. The congenital malformations reported to date do not reveal a pattern of defects. In conclusion, the evidence to date does not suggest a causal association between insulin glulisine and an increased risk of pregnancy complications or congenital malformations.

scholarly journals Systematic analysis of protein targets associated with adverse events of drugs from clinical trials and post-marketing reports

2020 ◽  
Author(s):  
Ines A. Smit ◽  
Avid M. Afzal ◽  
Chad H. G. Allen ◽  
Fredrik Svensson ◽  
Thierry Hanser ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Adverse Event Reporting System ◽  
Quantitative Information ◽  
Carbonic Anhydrases ◽  
Systematic Analysis ◽  
Post Marketing Surveillance ◽  
Post Marketing

AbstractAdverse drug reactions (ADRs) are undesired effects of medicines that can harm patients and are a significant source of attrition in drug development. ADRs are anticipated by routinely screening drugs against secondary pharmacology protein panels. However, there is still a lack of quantitative information on the links between these off-target proteins and the risk of ADRs in humans. Here, we present a systematic analysis of associations between measured and predicted in vitro bioactivities of drugs, and adverse events (AEs) in humans from two sources of data: the Side Effect Resource (SIDER), derived from clinical trials, and the Food and Drug Administration Adverse Event Reporting System (FAERS), derived from post-marketing surveillance. The ratio of a drug’s in vitro potency against a given protein relative to its therapeutic unbound drug plasma concentration was used to select proteins most likely to be relevant to in vivo effects. In examining individual target bioactivities as predictors of AEs, we found a trade-off between the Positive Predictive Value and the fraction of drugs with AEs that can be detected, however considering sets of multiple targets for the same AE can help identify a greater fraction of AE-associated drugs. Of the 45 targets with statistically significant associations to AEs, 30 are included on existing safety target panels. The remaining 15 targets include 8 carbonic anhydrases, of which CA5B was significantly associated with cholestatic jaundice. We include the full quantitative data on associations between in vitro bioactivities and AEs in humans in this work, which can be used to make a more informed selection of safety profiling targets.

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 The risk of malignancy is not increased in patients with multiple sclerosis treated with subcutaneous interferon beta-1a: analysis of data from clinical trial and post-marketing surveillance settings

2011 ◽  
Vol 17 (4) ◽  
pp. 431-440 ◽  
Author(s):  
Magnhild Sandberg-Wollheim ◽  
Gabrielle Kornmann ◽  
Dorina Bischof ◽  
Margaretha Stam Moraga ◽  
Brian Hennessy ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Safety Data ◽  
Data Set ◽  
Safety Database ◽  
Post Marketing Surveillance ◽  
Risk Of Malignancy ◽  
Post Marketing ◽  
Medical Dictionary

Background: Risks that are potentially associated with long-term therapies should be assessed. Objective: The present analyses were performed to determine the risk of malignancy in patients with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a, using pooled safety data from key clinical trials and data from the Merck Serono Global Drug Safety database. Methods: The standard Medical Dictionary for Regulatory Activities query “malignancies” was used to retrieve relevant cases from each data set. The incidence of malignancies per 1000 patient-years was calculated using the pooled safety data from clinical trials. The reporting rates of malignancy types were calculated for the post-marketing setting based on sales volume. Malignancies were grouped by organ localization and classified as medically confirmed or not medically confirmed according to the source of each report. The number of reported cases of each type was compared with the expected number in the general population. Results: Analysis of pooled safety data from 12 key clinical trials did not show an increased incidence of malignancy per 1000 patient-years with sc IFN beta-1a (4.0; 95% confidence interval (CI): 2.9–5.5) compared with placebo (6.4; 95% CI: 3.3–11.2). Analysis of the database shows that among the medically confirmed cases, reported to expected ratios ranged from 1 : 6 to 1 : 18 for solid tumours and from 1 : 2 to 1 : 9 for lymphohaematopoietic tumours. Conclusion: Safety data from both clinical trial and post-marketing settings suggest that treatment with sc IFN beta-1a does not increase the risk of malignancy in patients with MS.

scholarly journals Safety Profile of L-Glutamine in Patients with Sickle Cell Disease: Data from Post-Marketing Surveillance

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4184-4184
Author(s):  
Bhawna Rastogi ◽  
Sunita Rani ◽  
Meiko Mayuzumi ◽  
Rafael Razon ◽  
Rajani Singh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Abdominal Pain ◽  
Back Pain ◽  
Chest Pain ◽  
Side Effects ◽  
Sickle Cell Disease ◽  
Cell Disease ◽  
Safety Concerns ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background: L-glutamine (Endari ®) was approved by the US Food and Drug Administration (FDA) in July 2017 to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients, aged 5 years and older. Data collected during the phase 2 and phase 3 trials demonstrated a rather mild adverse event profile at the approved doses (approximately 0.3 g/kg administered twice daily). The combined data from the clinical trials encompassed 187 patients assigned to the L-glutamine arm and 111 patients assigned to the placebo arm. The most common side effects observed were constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain. Since 2017, safety data for L-glutamine has been collected through several sources. Aim: To determine whether new safety concern signals for L-glutamine in the treatment of SCD have emerged over the post-marketing period since July of 2017. Methods: Individual case safety reports (ICSR) received from consumers, physicians, pharmacies, and other healthcare professionals that were processed in the global safety database in real time were reviewed. Continuous safety evaluations that were performed when evaluating ICSRs were collected. Additionally, signal management activities performed quarterly since July 2017, which included screening of literature and regulatory websites for the identification of potential safety information, were evaluated. Results: Overall, 1791 case reports were received with 2954 adverse events between July 07, 2017 (the date of approval) and July 06, 2021. A summary of frequently reported adverse events during the post-marketing phase is presented in Figure 1. No new safety concerns have been identified upon evaluation of these events, which has been performed on a quarterly basis from the approval date. Conclusion: Post-marketing surveillance data indicates that L-glutamine administered at approximately 0.3 g/kg twice daily is safe and well-tolerated. The most common side effects observed during clinical trials were constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain (Table 1). These same side effects have been observed in the post-marketing phase with the exception of "cough." Side effects reported during the post-marketing phase that were not reported in the clinical trials were abdominal discomfort, diarrhea, malaise, and pain. The majority of these reports were categorized as non-serious (Figure 1). Information pertaining to these events was limited or the event could be explained by the underlying condition or concomitant medication; therefore, these events were not considered to be new safety concerns. In summary, there were no new safety concerns identified with L-glutamine for the treatment of SCD in the post-marketing period. Figure 1 Figure 1. Disclosures Mayuzumi: Emmaus Medical, Inc: Current Employment. Razon: Emmaus Medical, Inc: Current Employment. Singh: Emmaus Medical, Inc: Current Employment. Goodrow: Emmaus Medical, Inc: Current Employment. Becerra: Emmaus Medical, Inc: Current Employment. Stark: Emmaus Medical, Inc: Current Employment. Niihara: Emmaus Lifesciences, Inc.: Current Employment.

Triptans and Chest Symptoms: The Role of Pulmonary Vasoconstriction

Cephalalgia ◽  
2004 ◽  
Vol 24 (4) ◽  
pp. 298-304 ◽  
Author(s):  
DW Dodick
Keyword(s):  
Clinical Trials ◽  
Blood Vessels ◽  
Pulmonary Arteries ◽  
Common Adverse Effect ◽  
Intrinsic Activity ◽  
Pulmonary Vasculature ◽  
Surveillance Studies ◽  
Pulmonary Vasoconstriction ◽  
Post Marketing Surveillance ◽  
Post Marketing

Triptans are effective and well tolerated in the treatment of acute migraine. Chest symptoms are a common adverse effect unrelated to coronary vasoconstriction in most patients. Although the aetiology of chest symptoms remains to be fully defined, pulmonary vasoconstriction is a possible underlying mechanism. Preclinical studies of isolated human blood vessels were used to identify the cerebral selectivity of triptans and ascertain if selectivity vs the pulmonary vasculature predicts a lower rate of chest symptoms. Controlled clinical trials and post-marketing surveillance studies were reviewed to document the incidence of chest symptoms after triptan therapy. In clinical trials, the incidence of chest symptoms at usual therapeutic doses ranged from 1 to 4% depending on the triptan and study design, whereas in post-marketing surveillance studies, up to 41% of patients specifically asked about chest symptoms reported them. A comparative clinical trial showed that almotriptan was associated with lower incidence of chest symptoms than sumatriptan (0.3 vs 2.2%). The intrinsic activity of almotriptan, a second-generation triptan, on human pulmonary arteries and veins was lower than that of sumatriptan. Pre-clinical studies of isolated pulmonary blood vessels may predict the clinical likelihood of chest symptoms; however, additional comparisons are needed.

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