Food and Drug Administration Voluntary reporting of adverse events

1995 ◽  
Vol 1 (1) ◽  
pp. 32
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Voluntary Reporting

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

2018 ◽  
Vol 36 (18) ◽  
pp. 1805-1812 ◽  
Author(s):  
Thomas J. Hwang ◽  
Jessica M. Franklin ◽  
Christopher T. Chen ◽  
Julie C. Lauffenburger ◽  
Bishal Gyawali ◽  
...  
Keyword(s):  
Adverse Events ◽  
Solid Tumors ◽  
Drug Administration ◽  
Mechanism Of Action ◽  
Food And Drug Administration ◽  
Progression Free Survival ◽  
Cancer Drugs ◽  
Serious Adverse Events ◽  
Hazard Ratios ◽  
Fda Approval

Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non–breakthrough-designated cancer drugs approved by the US Food and Drug Administration (FDA). Methods We studied all new cancer drugs approved by the FDA between January 2012 and December 2017. Regulatory and therapeutic characteristics (time to FDA approval, pivotal trial efficacy end point, novelty of mechanism of action) were compared between breakthrough-designated and non–breakthrough-designated cancer drugs. Random-effects meta-regression was used to assess the association between breakthrough therapy designation and hazard ratios for progression-free survival (PFS), response rates (RRs) for solid tumors, serious adverse events, and deaths not attributed to disease progression. Results Between 2012 and 2017, the FDA approved 58 new cancer drugs, 25 (43%) of which received breakthrough therapy designation. The median time to first FDA approval was 5.2 years for breakthrough-designated drugs versus 7.1 years for non–breakthrough-designated drugs (difference, 1.9 years; P = .01). There were no statistically significant differences between breakthrough-designated and non–breakthrough-designated drugs in median PFS gains (8.6 v 4.0 months; P = .11), hazard ratios for PFS (0.43 v 0.51; P = .28), or RRs for solid tumors (37% v 39%; P = .74). Breakthrough therapy–designated drugs were not more likely to act via a novel mechanism of action (36% v 39%; P = 1.00). Rates of deaths (6% v 4%; P = .99) and serious adverse events (38% v 36%; P = 0.93) were also similar in breakthrough-designated and non–breakthrough-designated drugs. Conclusion Breakthrough-designated cancer drugs were associated with faster times to approval, but there was no evidence that these drugs provide improvements in safety or novelty; nor was there a statistically significant efficacy advantage when compared with non–breakthrough-designated drugs.

Unusual Distributions of Body Fat in AIDS Patients: A Review of Adverse Events Reported to the Food and Drug Administration

1999 ◽  
Vol 13 (5) ◽  
pp. 287-295 ◽  
Author(s):  
MARIANNE MANN ◽  
TONI PIAZZA-HEPP ◽  
ELIZABETH KOLLER ◽  
KIMBERLY STRUBLE ◽  
JEFF MURRAY
Keyword(s):  
Adverse Events ◽  
Body Fat ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Aids Patients

The FDA's Proposal for Public Disclosure of Adverse Events in Gene Therapy Trials

2000 ◽  
Vol 19 (2) ◽  
pp. 261-268
Author(s):  
Deborah R. Barnbaum
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Informed Consent ◽  
Adverse Events ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Public Disclosure

In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials.

scholarly journals Drug-Associated Delirium Identified in The Food and Drug Administration Adverse Events Reporting System

2019 ◽  
pp. 1-7
Author(s):  
Adrian Wong ◽  
Angela Li ◽  
Kane Gill ◽  
Matthew P. Gray ◽  
Pamela L. Smithburger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Public Knowledge ◽  
Future Studies ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing

Introduction: Drug toxicity and polypharmacy are major risk factors for delirium, especially in older adult patients with underlying comorbidities. However, numerous case reports have described drugs with a lower suspicion of being deliriogenic. The objective of this study was to identify deliriogenic drugs in the Food and Drug Administration Adverse Events Reporting System (FAERS) to broaden the public knowledge and understanding. Study Design: Retrospective pharmacovigilance evaluation. Methods: FAERS reports from 2004 through 2015 were reviewed for delirium-associated terms, which were utilized to identify drugs most frequently reported to cause delirium. Drugs were categorized as: 1) known to be deliriogenic; 2) potentially deliriogenic; or 3) new potential to be deliriogenic. The 100 most frequently reported drugs were analyzed in reporting odds ratios (ROR). Results: Of the known deliriogenic drugs (n=32), paroxetine (ROR 4.1, CI 4.0-4.3), olanzapine (ROR 3.3, CI 3.2-3.4), and clozapine (ROR 2.9, CI 2.8-3.0) were most reported. Of the potentially deliriogenic drugs (n=54), duloxetine (ROR 3.2, CI 3.1-3.3), varenicline (ROR 3.1, CI 3.0-3.2), and gabapentin (ROR 2.9, CI 2.7-3.0) were most reported. Three drugs were considered to have new potential to be deliriogenic: heparin (ROR 1.5, CI 1.4-1.6), metformin (ROR 1.3, CI 1.3-1.4), and dalfampridine (ROR 1.1, CI 1.1-1.2). Conclusion: The majority of drugs were considered potentially deliriogenic. FAERS can provide post-marketing surveillance data to guide future studies on potentially deliriogenic drugs to guide management of causal agents.

Mortality and adverse events with brand and generic clopidogrel in the US Food and Drug Administration Adverse Event Reporting System

2018 ◽  
Vol 5 (4) ◽  
pp. 210-215 ◽  
Author(s):  
Victor L Serebruany ◽  
Trygve S Hall ◽  
Dan Atar ◽  
Stefan Agewall ◽  
Moo Hyun Kim ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Chi Square ◽  
Event Reporting ◽  
The Us

Abstract Aims Clopidogrel is commonly used even after expiring patents. The brand clopidogrel (BC) was dealt by single company, while numerous manufacturers produce generic clopidogrel (GC). There are no convincing data to compare the safety of different formulations. Therefore, the data yielded from international, uniform, government-mandated registries may be useful. Methods and results We assessed primary causative adverse events (PCAE) after BC and GC in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). The outcomes were divided into death, cardiac, thrombotic/embolic, haemorrhagic, and rash/dermal complications. These primary endpoints were then examined by proportional reporting ratios (PRR) and chi-square (χ2). Among total FAERS (n = 9 466 679) reports, overall BC (n = 88 863) cases were more common than after GC (n = 36 559). When triaged by PCAE role, BC (n = 18 328) was also more abundant than GC (n = 3987). The reported death rates were more than doubled after BC [18.4% vs. 7.0%; PRR = 0.38; 95% confidence interval (95% CI) 0.32–0.43; χ2=369.7; P<0.0001] for total FAERS, and consistent for late 2010–2017 (17.6% vs. 7.0% PRR = 0.40; 95% CI 0.37–0.45; χ2=286.2; P<0.004) PCAE cases. In contrast, GC trended to co-report more cardiac (14.6% vs. 13.3%; PRR = 1.12; 95% CI 1.0–1.25; χ2=3.5; P<0.06). The haemorrhagic (40.9% vs. 32.3%; PRR = 1.45; 95% CI 1.33–1.57; χ2=75.8; P<0.0001), and rash/dermal (5.4% vs. 4.6%; PRR = 1.20; 95% CI 1.0–1.44; χ2=3.75; P<0.05) events were also more common for GC. Thrombotic/embolic events were reported equally (at 7.0%) after each formulation. Conclusion The PCAE profiles differ with BC and GC in FAERS. While deaths reports were higher, the rates of cardiac, haemorrhagic, and skin complications were less common for BC. Despite expected reporting bias, this may indicate that the manufacturers of GC are reluctant to report deaths to the FDA. However, the overall adverse event profile suggests potentially better safety of BC over GC formulations.

scholarly journals Benefit, burden, and impact for a cohort of post-approval cancer combination trials

2019 ◽  
Vol 17 (1) ◽  
pp. 18-29 ◽  
Author(s):  
Benjamin Gregory Carlisle ◽  
Adélaïde Doussau ◽  
Jonathan Kimmelman
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
National Comprehensive Cancer Network ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Guideline Recommendation ◽  
Anti Cancer ◽  
Grade 3 ◽  
Cancer Network

Background: After approval, drug developers often pursue trials aimed at extending the uses of a new drug by combining it with other drugs. Little is known about the risk and benefits associated with such research. Methods: To establish a historic benchmark of risk and benefit, we searched Medline and Embase for clinical trials testing anti-cancer drugs in combination within 5 years of approval by the Food and Drug Administration of 12 anti-cancer “index” drugs first licensed 2005–2007 inclusive. Risk was assessed based on grade 3 or above drug-related adverse events; benefit was assessed based on efficacy outcomes and advancement of combinations into clinical practice guidelines or approval by the Food and Drug Administration. Results: We captured 323 published post-approval trials exploring combinations, including 266 unique combination–indication pairings and enrolling 29,835 patients. The pooled risk ratios for treatment-related grade 3–4 severe adverse events and deaths attributed to the study drugs for trials randomized between a combination arm and a comparator were 1.54 (1.33–1.79) and 1.51 (1.16–1.97), respectively. The pooled hazard ratios for overall survival and progression-free survival were 0.99 (0.92–1.05) and 0.85 (0.79–0.93), respectively. None of the combination–indication pairings launched after initial drug approval received approval by the Food and Drug Administration, and 13 pairings (4.9%) were recommended by the National Comprehensive Cancer Network within 5 years of the first trial within that pairing. The proportion of patients in our sample who participated in trials leading to an approval by the Food and Drug Administration or a National Comprehensive Cancer Network guideline recommendation was 12.7% with 5 years of follow-up, and 22.3% among pairings for which there were 8 years of follow-up. Conclusion: Patients were just as likely to benefit in the treatment arm as the control arm in terms of overall survival, but they were more likely to experience a treatment-related severe adverse event in post-approval trials of combination therapy.

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