Tigecycline‐Related Pancreatitis: A Review of Spontaneous Adverse Event Reports

Okon, Emmanuel Etim; Engell, Christian; Manen, Robbert Van; Brown, Jack

doi:10.1002/phar.1159

Cited by 25 publications

(22 citation statements)

References 15 publications

(38 reference statements)

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“…Other antibiotics with MRSA activity such as ceftaroline, ceftobiprole, telavancin, and tigecycline represent alternatives for the treatment of infections caused by drug-resistant Gram-positive pathogens [ 8 ]. However, there are some reports of safety issues associated with these antibiotics; hematological disorders and rash with ceftaroline, gastrointestinal upset with ceftobiprole, nephrotoxicity with telavancin, and pancreatitis with tigecycline [ 9 – 12 ].…”

Section: Introductionmentioning

confidence: 99%

Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

Seaton

Gonzalez-Ruiz

Cleveland

et al. 2016

Ann Clin Microbiol Antimicrob

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BackgroundPooled data from two large registries, Cubicin® Outcomes Registry and Experience (CORE; USA) and European Cubicin® Outcomes Registry and Experience (EU-CORE; Europe, Latin America, and Asia), were analyzed to determine the characteristics and clinical outcomes of daptomycin therapy in patients with Gram-positive infections across wide geographical regions.MethodsPatients receiving at least one dose of daptomycin between 2004 and 2012 for the treatment of Gram-positive infections were included. Clinical success was defined as an outcome of ‘cured’ or ‘improved’. Post-treatment follow-up data were collected for a subset of patients (CORE: osteomyelitis and orthopedic foreign body device infection; EU-CORE: endocarditis, intracardiac/intravascular device infection, osteomyelitis, and orthopedic device infection). Safety was assessed for up to 30 days after daptomycin treatment.ResultsIn 11,557 patients (CORE, 5482; EU-CORE, 6075) treated with daptomycin (median age, 62 [range, 1–103] years), the most frequent underlying conditions were cardiovascular disease (54.7 %) and diabetes mellitus (28.0 %). The most commonly treated primary infections were complicated skin and soft tissue infection (cSSTI; 31.2 %) and bacteremia (21.8 %). The overall clinical success rate was 77.2 % (uncomplicated SSTI, 88.3 %; cSSTI, 81.0 %; osteomyelitis, 77.7 %; foreign body/prosthetic infection (FBPI), 75.9 %; endocarditis, 75.4 %; and bacteremia, 69.5 %). The clinical success rate was 79.1 % in patients with Staphylococcus aureus infections (MRSA, 78.1 %). An increasing trend of high-dose daptomycin (>6 mg/kg/day) prescribing pattern was observed over time. Clinical success rates were higher with high-dose daptomycin treatment for endocarditis and FBPI. Adverse events (AEs) and serious AEs possibly related to daptomycin therapy were reported in 628 (5.4 %) and 133 (1.2 %) patients, respectively.ConclusionsThe real-world data showed that daptomycin was effective and safe in the treatment of various Gram-positive infections, including those caused by resistant pathogens, across wide geographical regions.

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Section: Introductionmentioning

confidence: 99%

Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

Seaton

Gonzalez-Ruiz

Cleveland

et al. 2016

Ann Clin Microbiol Antimicrob

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“…Pancreatitis has been identified in pharmacovigilance databases during post-approval use of tigecycline. 9,11,12 Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.…”

Section: Discussionmentioning

confidence: 99%

Pancreatitis in tigecycline Phase 3 and 4 clinical studies

McGovern

Wible

Korth‐Bradley

et al. 2013

Journal of Antimicrobial Chemotherapy

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ObjectivesTo examine the incidence of pancreatitis among subjects enrolled in the tigecycline clinical trial programme, summarize cases and examine concomitant use of other pancreatitis-causing medications.MethodsSubject data from Phase 3 and 4 comparative tigecycline studies were included in the analysis; investigator-reported adverse events of ‘pancreatitis’, ‘necrotizing pancreatitis’ or ‘pancreas disorder’ were reviewed. Data were summarized and cases were reported. No statistical comparisons were made. The incidence of overall pancreatitis with 95% CIs was calculated. The Wilson score method was used to calculate CIs.ResultsNineteen subjects with investigator-determined pancreatitis were identified from the programme database, which included 3788 subjects treated with tigecycline and 3646 subjects treated with a comparator. There were 9 cases identified among the tigecycline-treated subjects [9 of 3788 (0.24%; 95% CI, 0.11–0.45)] and 10 cases among the comparator-treated subjects [10 of 3646 (0.27%; 95% CI, 0.13–0.50)]. The demographic characteristics of the subjects with pancreatitis were similar between treatment groups. The median duration of tigecycline therapy was 8.0 days compared with 11.0 days of comparator treatment. Concomitant or prior exposure to a Badalov class I medication was evident in the majority of subjects who developed pancreatitis. A numerically higher number of tigecycline-treated subjects were exposed to furosemide prior to the onset of pancreatitis than comparator-treated subjects.ConclusionsPancreatitis was uncommon in subjects treated with tigecycline, with an occurrence of <1%. Concomitant medications known to cause pancreatitis should be considered when prescribing tigecycline, but may not identify those at risk of developing pancreatitis.

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“…Limitations to both studies, however, include the inability to enforce standardized criteria for drug-induced pancreatitis as well as inability to re-challenge patients with the drug. Thus, cause-and-effect determination was not possible with either review [2,3].…”

Section: Okon Et Al Performed a Review Of The Fda Adverse Eventmentioning

confidence: 92%

“…Reporting System, the results of which revealed an increase in pancreatitis reports (with the 5th percentile of the distribution of the relative reporting ratio [RRR 05 ] of 10.4) [2]. In contrast, a subsequent review of Phase 3 and 4 comparative tigecycline studies by McGovern et al concluded that the incidence of tigecycline-associated pancreatitis did not exceed comparator antibiotics, occurring in less than 1% of all cases of exposure.…”

Section: Okon Et Al Performed a Review Of The Fda Adverse Eventmentioning

confidence: 93%

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Tigecycline-induced acute pancreatitis in a cystic fibrosis patient: A case report and literature review

Hemphill¹,

Jones

2016

Journal of Cystic Fibrosis

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Tigecycline‐Related Pancreatitis: A Review of Spontaneous Adverse Event Reports

Abstract: Our analysis suggests a quantitative signal between tigecycline use and pancreatitis; however, given the limitations of our study, a cause-and-effect relationship cannot be inferred. Thus, additional rigorous scientific analyses are warranted to explore these findings.

Cited by 25 publications

References 15 publications

Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

Pancreatitis in tigecycline Phase 3 and 4 clinical studies

Tigecycline-induced acute pancreatitis in a cystic fibrosis patient: A case report and literature review

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