Severe statin‐induced rhabdomyolysis mimicking Guillain–Barré syndrome in four patients with diabetes mellitus treated with fusidic acid

Collidge, Tara; Razvi, Saif; Nolan, C.E.; Whittle, Martin; Stirling, CM; Russell, Allen; Mann, A C; Deighan, Christopher J.

doi:10.1111/j.1464-5491.2010.02984.x

Cited by 17 publications

(10 citation statements)

References 42 publications

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“…The FA package insert and the medical literature suggests inhibition of CYP3A4 by FA as a likely mechanism of muscular side effects (Burtenshaw et al, 2008;Collidge et al, 2010;Teckchandani et al, 2010;Kearney et al, 2012), since CYP3A4 is principally responsible for the metabolic clearance of atorvastatin and simvastatin in humans (Lennernäs, 2003;Elsby et al, 2012). However, it is now widely recognized that the systemic clearance of statins such as atorvastatin, simvastatin, and rosuvastatin is predominantly determined by the hepatic uptake mediated by organic anion transporting polypeptides (OATPs; OATP1B1, OATP1B3, and OATP2B1) (Neuvonen et al, 2006;Kitamura et al, 2008;Zamek-Gliszczynski et al, 2009;König et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

“…Furthermore, in countries where FA is available, chronic oral therapy with FA is routinely used in the treatment of Staphylococcus-mediated prosthetic joint infections among the elderly population (Aboltins et al, 2007;Wang et al, 2012). The widespread clinical use of FA in suppressive antibiotic therapy is also associated with several cases of life-threatening rhabdomyolysis (with fatalities) upon coadministration with the 3-hydroxy-3-methylglutaryl CoA reductase inhibitors, atorvastatin and simvastatin (Wenisch et al, 2000;Yuen and McGarity, 2003;Burtenshaw et al, 2008;O'Mahony et al, 2008;Herring et al, 2009;Saeed and Azam, 2009;Collidge et al, 2010;Magee et al, 2010;Teckchandani et al, 2010;Kearney et al, 2012;Gabignon et al, 2013), and more recently, rosuvastatin (Cowan et al, 2013). The package insert for sodium fusidate (Fusidin tablets) was also recently amended with additional warnings to reflect the adverse musculoskeletal findings (https://www.medicines.org.uk/emc/medicine/2448).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The Antimicrobial Agent Fusidic Acid Inhibits Organic Anion Transporting Polypeptide-Mediated Hepatic Clearance and May Potentiate Statin-Induced Myopathy

Eng

Scialis

Rotter

et al. 2016

Drug Metabolism and Disposition

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Chronic treatment of methicillin-resistant Staphylococcus aureus strains with the bacteriostatic agent fusidic acid (FA) is frequently associated with myopathy including rhabdomyolysis upon coadministration with statins. Because adverse effects with statins are usually the result of drug-drug interactions, we evaluated the inhibitory effects of FA against human CYP3A4 and clinically relevant drug transporters such as organic anion transporting polypeptides OATP1B1 and OATP1B3, multidrug resistant protein 1, and breast cancer resistance protein, which are involved in the oral absorption and/or systemic clearance of statins including atorvastatin, rosuvastatin, and simvastatin. FA was a weak reversible (IC 50 = 295 6 1.0 mM) and time-dependent (K I = 216 6 41 mM and k inact = 0.0179 6 0.001 min 21) inhibitor of CYP3A4-catalyzed midazolam-19-hydroxylase activity in human liver microsomes. FA demonstrated inhibition of multidrug resistant protein 1-mediated digoxin transport with an IC 50 value of 157 6 1.0 mM and was devoid of breast cancer resistance protein inhibition (IC 50 > 500 mM). In contrast, FA showed potent inhibition of OATP1B1-and OATP1B3-specific rosuvastatin transport with IC 50 values of 1.59 mM and 2.47 mM, respectively. Furthermore, coadministration of oral rosuvastatin and FA to rats led to an approximately 19.3-fold and 24.6-fold increase in the rosuvastatin maximum plasma concentration and area under the plasma concentration-time curve, respectively, which could be potentially mediated through inhibitory effects of FA on rat Oatp1a4 (IC 50 = 2.26 mM) and Oatp1b2 (IC 50 = 4.38 mM) transporters, which are responsible for rosuvastatin uptake in rat liver. The potent inhibition of human OATP1B1/OATP1B3 by FA could attenuate hepatic uptake of statins, resulting in increased blood and tissue concentrations, potentially manifesting in musculoskeletal toxicity.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Antimicrobial Agent Fusidic Acid Inhibits Organic Anion Transporting Polypeptide-Mediated Hepatic Clearance and May Potentiate Statin-Induced Myopathy

Eng

Scialis

Rotter

et al. 2016

Drug Metabolism and Disposition

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“…A total of 29 cases of rhabdomyolysis were identified in the literature during co‐administration of statin and fusidic acid, the oldest publication dating back to 1992 (Table ). They originated from six different countries: Ireland (45%), United Kingdom (28%), France (10%), Austria (7%), Australia (7%) and Denmark (3%).…”

Section: Resultsmentioning

confidence: 99%

Rhabdomyolysis after co‐administration of a statin and fusidic acid: an analysis of the literature and of the WHO database of adverse drug reactions

Deljehier

Pariente

Miremont-Salamé

et al. 2018

Brit J Clinical Pharma

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Following a severe case of rhabdomyolysis in our University Hospital after a co-administration of atorvastatin and fusidic acid, we describe this interaction as this combination is not clearly contraindicated in some countries, particularly for long-term treatment by fusidic acid. All cases of rhabdomyolysis during a co-administration of a statin and fusidic acid were identified in the literature and in the World and Health Organization database, VigiBase . In the literature, 29 cases of rhabdomyolysis were identified; mean age was 66 years, median duration of co-administration before rhabdomyolysis occurrence was 21 days, 28% of cases were fatal. In the VigiBase , 182 cases were retrieved; mean age was 68 years, median duration of co-administration before rhabdomyolysis was 31 days and 24% of cases were fatal. Owing to the high fatality associated with this co-administration and the long duration of treatment before rhabdomyolysis occurrence, fusidic acid should be used if there is no appropriate alternative, as long as statin therapy is interrupted for the duration of fusidic acid therapy, and perhaps a week longer. Rarely will interruption of this sort have adverse consequences for the patient.

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“…The patients' characteristics are similar to those of 18 previously reported cases (table 2⇓). [6][7][8][9][10][11][12][13][14][15][16][17] .…”

Section: Cohortmentioning

confidence: 99%

Rhabdomyolysis after co-prescription of statin and fusidic acid

Kearney¹,

Carr²,

McConville³

et al. 2012

BMJ

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Severe statin‐induced rhabdomyolysis mimicking Guillain–Barré syndrome in four patients with diabetes mellitus treated with fusidic acid

Abstract: Background An interaction between fusidic acid and HMG coenzyme A reductase inhibitors (statins), resulting in rhabdomyolysis, has been described. Pain and mild weakness are common presenting symptoms.

Cited by 17 publications

References 42 publications

The Antimicrobial Agent Fusidic Acid Inhibits Organic Anion Transporting Polypeptide-Mediated Hepatic Clearance and May Potentiate Statin-Induced Myopathy

The Antimicrobial Agent Fusidic Acid Inhibits Organic Anion Transporting Polypeptide-Mediated Hepatic Clearance and May Potentiate Statin-Induced Myopathy

Rhabdomyolysis after co‐administration of a statin and fusidic acid: an analysis of the literature and of the WHO database of adverse drug reactions

Rhabdomyolysis after co-prescription of statin and fusidic acid

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