Evidence map›Paper›PMID 24442762›Full record

ReviewDrug safety2014

Sumatriptan-associated ischemic colitis: case report and review of the literature and FAERS.

Thuc Quyen Nguyen, James H Lewis

Abstract readReview
PubMed Publisher
In one paragraph

Review in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Thuc Quyen NguyenDivision of Gastroenterology, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA.
James H Lewis
Georgetown University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsIschemic colitis (IC) is being increasingly recognized, although specific etiological causes are observed in a minority of patients. While several drugs have been associated with IC, most remain anecdotal reports. We recently treated a patient with IC thought to be related to sumatriptan for migraines, and performed a literature review along with a review of the FDA Adverse Event Reporting System (FAERS) database to identify additional cases.

methodsA MEDLINE/PubMed literature review was conducted using standard IC search terms to identify published cases of sumatriptan and other related "triptan" drug causes of IC. In addition, through a Freedom of Information Act request, we reviewed the adverse gastrointestinal events linked to sumatriptan contained in the FAERS database for the 5-year period 12 March 2008-11 March 2013, in order to determine whether unpublished cases might exist. Our case of IC was analyzed using a causality assessment tool initially developed for use in cases of alosetron (a 5-HT3 receptor antagonist)-related IC.

resultsFive published reports (containing a total of seven patients) describing sumatriptan-associated IC in the English language literature were found and reviewed. Another four published reports of related 5-HT1 receptor agonists causing IC (razitriptan n = 1 and naratriptan n = 3) were also analyzed. Among spontaneous reports of possible IC contained in the FAERS database for sumatriptan, there were 19 adverse events coded as "ischemic colitis" and another six coded as "intestinal ischemia" over a 5-year period ending March 2013, but clinical details were lacking. Similarly, five reports of possible IC from FAERS were mentioned in an earlier published report from the late 1990s. All of the published case reports of sumatriptan and related drugs were deemed to have the classic clinical findings and all recovered. There was one instance of possible recurrent IC symptoms in one patient re-exposed to sumatriptan, but not in another. We found that the IC scoring system developed for alosetron was applicable in our sumatriptan case.

conclusionsAmong drug-related causes of IC, sumatriptan joins a growing list of agents with literature reports supported by the finding of suspected cases of IC in the FAERS database. However, the true incidence of IC due to sumatriptan, as well as other causes, cannot be accurately determined because of the likelihood of under-reporting. The structured IC scoring system appears to be applicable for drug-related as well as other etiological causes of IC.

Indexed as

Adverse Drug Reaction Reporting SystemsColitis, IschemicColonoscopyHumansIntestinal MucosaSerotonin 5-HT1 Receptor AgonistsSumatriptanSerotonin 5-HT1 Receptor AgonistsSumatriptan

Identifiers

PMID24442762
OpenAlexW1969964382

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.