Cutaneous Adverse Effects of Ketoprofen for Topical Use

Noïze, Pernelle; Bénard‐Laribière, Anne; Aulois-Griot, Marine; Moore, Nicholas; Miremont-Salamé, Ghada; Haramburu, Françoise

doi:10.2165/11530160-000000000-00000

Cited by 13 publications

(14 citation statements)

References 14 publications

(12 reference statements)

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“…The costs of skin ADEs related to antineoplastic agents were estimated from €1,592.89 to €15,037.97 36,37. A study evaluated the costs of nonserious and serious skin ADEs according to spontaneous reports; the incremental total cost per patient was estimated as €373.33 and €3,383.56, respectively 38. Suh et al estimated the costs of levodopa-induced dyskinesia as €4,617.65 39.…”

Section: Resultsmentioning

confidence: 99%

A systematic review of observational studies evaluating costs of adverse drug reactions

Marques¹,

Penedones²,

Mendes³

et al. 2016

CEOR

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IntroductionThe growing evidence of the increased frequency and severity of adverse drug events (ADEs), besides the negative impact on patient’s health status, indicates that costs due to ADEs may be steadily rising. Observational studies are an important tool in pharmacovigilance. Despite these studies being more susceptible to bias than experimental designs, they are more competent in assessing ADEs and their associated costs.ObjectiveTo identify and characterize the best available evidence on ADE-associated costs.MethodsMEDLINE, Cochrane Library, and Embase were searched from 1995 to 2015. Observational studies were included. The methodological quality of selected studies was assessed by Cochrane Collaboration tool for experimental and observational studies. Studies were classified according to the setting analyzed in “ambulatory”, “hospital”, or both. Costs were classified as “direct” and “indirect”. Data were analyzed using descriptive statistics. The total incremental cost per patient with ADE was estimated.ResultsTwenty-nine (94%) longitudinal observational studies and two (7%) cross-sectional studies were included. Twenty-three (74%) studies were assessed with the highest methodological quality score. The studies were mainly conducted in the US (61%). Twenty (65%) studies evaluated any therapeutic group. Twenty (65%) studies estimated costs of ADEs leading to or prolonging hospitalization. The “direct costs” were evaluated in all studies, whereas only two (7%) also estimated the “indirect costs”. The “direct costs” in ambulatory ranged from €702.21 to €40,273.08, and the in hospital from €943.40 to €7,192.36.DiscussionMethodological heterogeneities were identified among the included studies, such as design, type of ADEs, suspected drugs, and type and structure of costs. Despite such discrepancies, the financial burden associated with ADE costs was found to be high. In the light of the present findings, validated methods to measure ADE-associated costs need future research efforts.

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Section: Resultsmentioning

confidence: 99%

A systematic review of observational studies evaluating costs of adverse drug reactions

Marques¹,

Penedones²,

Mendes³

et al. 2016

CEOR

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“…PACD is considered as an uncommon or rare condition, and limited data are available concerning incidence. In Italy, the observed rate of any reported photosensitivity reaction to drugs (including photoallergy and phototoxicity from topical and systemic agents) was 1.86 per million inhabitants per year (corresponding to 5.5 per 100 000 adverse reactions reported) . Similarly, in Norway, a retrospective analysis of adverse drug reaction reports for the years 1970–1995 revealed that approximately 5 per 100 000 reactions were classified as photosensitivity …”

Section: Introductionmentioning

confidence: 99%

Development of a clinical score system for the diagnosis of photoallergic contact dermatitis using a consensus process: item selection and reliability

Cazzaniga

Lecchi

Bruze

et al. 2014

Acad Dermatol Venereol

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“…; Noize et al. ). To date, however, there is limited information on the incidence of severe photosensitivity reactions leading to hospitalization among topical ketoprofen users as compared with users of other topical NSAIDs.…”

Section: Introductionmentioning

confidence: 97%

“…; Noize et al. ). In an analysis of spontaneous reports in Italy, the observed reporting rate of photosensitivity reactions from any causes was 5.5 per 100,000 inhabitants per year and the rate of serious photosensitivity reactions was 0.09 per 100,000 inhabitants per year (Naldi et al.…”

Section: Introductionmentioning

confidence: 97%

“…Topical ketoprofen is used in more than 70 countries worldwide. Since its first market authorization in Europe in 1972, cases of photoallergic contact dermatitis related to ketoprofen use have been described and characterized (Bagheri et al 2000;Matthieu et al 2004;Cantisani et al 2010;Noize et al 2010). To date, however, there is limited information on the incidence of severe photosensitivity reactions leading to hospitalization among topical ketoprofen users as compared with users of other topical NSAIDs.…”

Section: Introductionmentioning

confidence: 99%

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A pilot study on the incidence of severe photosensitivity reactions leading to hospitalization linked to topical ketoprofen and other medications in selected European regions

Cazzaniga

Naldi

Lecchi

et al. 2016

Pharmacology Res & Perspec

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The aim of this study was to assess the prevalence of exposure to topical nonsteroidal anti‐inflammatory drugs (NSAIDs), particularly ketoprofen, in a convenience sample of the population, to obtain estimates of the incidence of severe photosensitivity leading to hospitalization, and to assess causative factors in three catchment areas: the Paris metropolitan area, the Lombardy region (Italy) and the Prague area. All cases of severe photosensitivity not explained by underlying conditions and admitted to hospitals in the selected areas were included in the study. Controls were patients consecutively admitted to hospitals, in the same areas, for an acute condition or for an elective procedure not suspected of being related to medication use. From October 2012 to September 2013, 920 controls were recruited (median age 44 years, 50.8% females); 8 severe photosensitivity cases were reported in the population aged 18–74 years of the 3 geographical areas during the 1‐year surveillance period, corresponding to an incidence rate of 4.81 cases per 10 million person‐years (95% confidence interval – CI, 2.07–9.48). Six controls reported 1‐month exposure to topical ketoprofen, with an estimated prevalence of 0.65% (95% CI, 0.24–1.42). The population attributable risk for severe photosensitivity reactions linked to ketoprofen was 11.92% (95% CI, −0.12–52.99). This study was conducted in selected European areas and showed that the incidence of severe photosensitivity reactions leading to hospitalization as well as the exposure rate to topical ketoprofen were low. Among topical NSAIDs, topical ketoprofen was the leading cause of photosensitivity reactions but accounted for a limited number of hospitalized cases. Probably most of the relevant reactions were managed in the outpatient setting and a community based case–control study is advisable.

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Cutaneous Adverse Effects of Ketoprofen for Topical Use

Abstract: Topical ketoprofen is used to treat benign symptoms but can be associated with serious and costly cutaneous ADRs. Furthermore, the number of cases and the calculated costs may have been greatly under-estimated in the present study.

Cited by 13 publications

References 14 publications

A systematic review of observational studies evaluating costs of adverse drug reactions

A systematic review of observational studies evaluating costs of adverse drug reactions

Development of a clinical score system for the diagnosis of photoallergic contact dermatitis using a consensus process: item selection and reliability

A pilot study on the incidence of severe photosensitivity reactions leading to hospitalization linked to topical ketoprofen and other medications in selected European regions

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