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Collaboration in pharmacovigilance: lamotrigine and fatal severe cutaneous adverse reactions – a review of spontaneous reports

Overview of attention for article published in Therapeutics and Clinical Risk Management, July 2017
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About this Attention Score

  • In the top 5% of all research outputs scored by Altmetric
  • Among the highest-scoring outputs from this source (#32 of 1,252)
  • High Attention Score compared to outputs of the same age (93rd percentile)
  • High Attention Score compared to outputs of the same age and source (99th percentile)

Mentioned by

twitter
54 tweeters

Citations

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4 Dimensions

Readers on

mendeley
15 Mendeley
Title
Collaboration in pharmacovigilance: lamotrigine and fatal severe cutaneous adverse reactions – a review of spontaneous reports
Published in
Therapeutics and Clinical Risk Management, July 2017
DOI 10.2147/tcrm.s131021
Pubmed ID
Authors

Neil Brickel, Muhammad Haris S Shaikh, Andrew Kirkham, Greg Davies, Michelle Chalker, Pascal Yoshida

Abstract

Pharmacovigilance presents many challenges, particularly when managing unpredictable, rare conditions, eg, severe cutaneous adverse reactions (SCARs). Such rare events are often only detected from spontaneous reports, which present their own limitations, particularly during a prolonged global launch schedule. GlaxoSmithKline's routine pharmacovigilance includes regular reviews of global adverse event (AE) reports and aggregate data from a central safety database. Lamotrigine is one of the several antiepileptic drugs associated with SCARs. After identification of increased rates of fatal SCAR cases with lamotrigine in Japan between September and December 2014, this analysis investigated the global incidence of fatal SCARs with lamotrigine and explored whether known risk factors may have contributed to these cases. Global fatal SCAR cases reported with lamotrigine administration from launch until January 2015 were reviewed for evidence of temporal association with dosing and the presence of risk factors, including comorbidities, concomitant medications, and noncompliance with the prescribing information (PI). Worldwide, the estimated cumulative exposure to lamotrigine was >8.4 million patient-years. Globally, there were 54,513 AE reports for lamotrigine, of which 3,454 (6.3%) concerned SCARs. Of these, 122 (3.5%) had a fatal outcome (attributable and nonattributable to lamotrigine), equating to 0.01 fatal SCARs per 1,000 patient-years. In Japan (estimated cumulative exposure 141,000 patient-years), 17 fatal SCARs were reported (attributable and nonattributable), equating to 0.12 per 1,000 patient-years. Seventy-one percent of fatal SCAR cases in Japan showed evidence of noncompliance with the recommended dosing regimen; in 65% of the cases, a delay in discontinuation of lamotrigine after early signs of hypersensitivity was reported. Despite a number of limitations inherent in comparing spontaneous report data, this analysis highlights the need for adherence to the lamotrigine PI and emphasizes the importance of collaboration between global and local pharmacovigilance departments, to promptly identify and reduce the risk of rare and serious events, such as SCARs.

Twitter Demographics

The data shown below were collected from the profiles of 54 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 15 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 15 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 4 27%
Student > Ph. D. Student 3 20%
Student > Doctoral Student 2 13%
Professor 1 7%
Student > Master 1 7%
Other 2 13%
Unknown 2 13%
Readers by discipline Count As %
Medicine and Dentistry 6 40%
Pharmacology, Toxicology and Pharmaceutical Science 2 13%
Agricultural and Biological Sciences 1 7%
Nursing and Health Professions 1 7%
Psychology 1 7%
Other 1 7%
Unknown 3 20%

Attention Score in Context

This research output has an Altmetric Attention Score of 38. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 22 August 2017.
All research outputs
#884,010
of 22,317,911 outputs
Outputs from Therapeutics and Clinical Risk Management
#32
of 1,252 outputs
Outputs of similar age
#19,444
of 291,724 outputs
Outputs of similar age from Therapeutics and Clinical Risk Management
#1
of 23 outputs
Altmetric has tracked 22,317,911 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 96th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,252 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 8.4. This one has done particularly well, scoring higher than 97% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 291,724 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 93% of its contemporaries.
We're also able to compare this research output to 23 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 99% of its contemporaries.