Adverse Event Reporting Patterns of Newly Approved Drugs in the USA in 2006: An Analysis of FDA Adverse Event Reporting System Data

Chhabra, Pankdeep; Chen, Xing; Weiss, Sheila R.

doi:10.1007/s40264-013-0115-x

Cited by 14 publications

(12 citation statements)

References 11 publications

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“…Taken together, these data suggest that early phase trials have acceptable safety profiles. Furthermore, important toxicities can also be discovered after an agent is approved by the FDA and in post-approval surveillance analyses 61,62 , and do not detract from viewing that drug as a therapeutic agent.…”

Section: [H1] Incidence Of Toxicitiesmentioning

confidence: 99%

Phase I trials as valid therapeutic options for patients with cancer

et al. 2019

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Section: [H1] Incidence Of Toxicitiesmentioning

confidence: 99%

Phase I trials as valid therapeutic options for patients with cancer

et al. 2019

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“…32 Frequency of reporting can also vary over time, depending on how long a drug has been on the market (Weber effect), or in response to periods of media activity or safety alerts by regulatory authorities (notoriety effect, stimulated reporting). 31,[41][42][43][44] Several steps to reduce potential sources of bias were taken in the present study design, including temporally matching reporting period of each product to the same period within the lifecycle of the product to minimize the Weber effect, and applying the same case definition to each product to identify the eligible cases using the same specific set of 16 MedDRA PTs.…”

Section: Discussionmentioning

confidence: 99%

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases

Park-Wyllie¹,

Stralen

Castillon

et al. 2017

Clinical Therapeutics

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The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada.

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“…It also is possible for there to be overreporting (or ''stimulated'' reporting) for some events depending on their prominence in the media, although recent work suggests this may not always be the case. 34 A referee has pointed out that events that are easily attributable to a drug, for example, skin reactions and liver function test elevations, are frequently reported, but drug-related malignancies are almost impossible to detect through spontaneous reports. The FDA maintains separate spontaneous AE reporting systems for drugs, vaccines, and medical devices.…”

Section: General Issuesmentioning

confidence: 99%

Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group

Gould

Lystig

et al. 2015

Ther Innov Regul Sci

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Spontaneous reporting (SR) adverse event system databases, large observational databases, large clinical trials, and large health records databases comprise repositories of information that may be useful for early detection of potential harms associated with drugs, devices, and vaccines. All of the data sources include many different adverse events and many medical products, so that any approach designed to detect "important" signals of potential harm must have adequate specificity to protect against false alarms yet provide satisfactory sensitivity for detecting issues that really need further investigation. Algorithms for evaluating potential risks using information from these sources, especially SR databases, have been described in the literature. The algorithms may seek to identify potential product-event associations without any prior specifications, to identify events associated with a particular product or set of products, or to identify products associated with a particular event or set of events. This article provides recommendations for using information from postmarketing spontaneous adverse event reporting databases to provide insight into risks of potential harm expressed by safety signals and offers guidance regarding appropriate methods, both frequentist and Bayesian, to use in various situations as a function of the objective of the analysis.

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Adverse Event Reporting Patterns of Newly Approved Drugs in the USA in 2006: An Analysis of FDA Adverse Event Reporting System Data

Cited by 14 publications

References 11 publications

Phase I trials as valid therapeutic options for patients with cancer

Phase I trials as valid therapeutic options for patients with cancer

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases

Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group

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