Pregabalin-Induced Hepatotoxicity

Sendra, Juan Moll; Junyent, Teresa Torrecilla; Pellicer, Maria José Remigia

doi:10.1345/aph.1q032

Cited by 38 publications

(22 citation statements)

References 9 publications

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“…Oxcarbazepine [35] and baclofen [36] have also shown a low hepatic impact; it is to be noted that the patients were detoxified prior to treatment in the oxcarbazepine study, and patients in the baclofen study drank relatively less at baseline assessment compared to our study cohort. Gabapentin and pregabalin treatment for neuropathic pain has been reported in a few cases to cause liver injury [37, 38]; however, one review concludes it to be safe in mild alcoholic liver disease [39]. In this context quetiapine XR provides therapy in an alcohol-drinking population where hepatic injury is likely, and interaction of the treatment could potentially result in liver injury or exacerbation of ongoing liver injury.…”

Section: Discussionmentioning

confidence: 99%

Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

et al. 2016

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Background Studies have reported liver injury as a consequence of antipsychotic treatment. Very heavy alcohol drinking (ten or more drinks/day for men and eight for women) also causes liver injury. This study aims to evaluate liver injury with quetiapine extended release (XR) in very heavy drinking alcohol-dependent (AD) patients. Methods Two hundred and eighteen AD patients, 18–65 years of age, received 12 weeks of quetiapine XR or placebo treatment in a dose-escalated manner reaching the full dose of 400 mg/day during week 4. Blood chemistry and hematology were assessed at baseline (W0), post-titration at the end of week 3 (W4), week 8 (W8), and end of week 12 (W13). Patients were further grouped as GR.1 (no liver injury, ALT ≤40) and GR.2 (pre-existing liver injury, ALT >40) within each treatment. Drinking history, fasting blood glucose concentration (FBG), and lipid panel were used as covariates in the analyses. Results Liver injury and total drinks and average drinking measures from the Timeline follow-back questionnaire (TLFB) were highly associated. No significant exacerbation in liver injury was observed in patients treated with quetiapine XR in GR.2. Liver injury as determined by elevated alanine aminotransaminase (ALT) was reported in a few patients in GR.1 who received quetiapine XR; however, the occurrence was low, and the level of liver injury was not significant. FBG and lipid measures showed some elevation, but did not show any significant association with liver injury. Conclusion Quetiapine XR did not show any significant exacerbation of liver injury in very heavy drinking alcohol-dependent patients with pre-existing liver injury. Frequency and severity of new liver injury cases in quetiapine XR-treated patients without any pre-existing liver injury was also low. Study findings support medical management of AD patients with heavy drinking profile using quetiapine XR formulation.

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Section: Discussionmentioning

confidence: 99%

Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

et al. 2016

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“…Pregabalin is usually well tolerated; however, adverse effects can include dizziness, somnolence, peripheral edema, asthenia, dry mouth, and weight gain (18). There have also been reports of heart failure (19), rashes (20), and increased liver enzyme levels (21). Neutropenia has rarely been reported as an adverse effect of pregabalin, with only a single case report of pregabalinassociated neutropenia (5).…”

Section: Discussionmentioning

confidence: 99%

<i>Clostridium difficile</i> Infection Induced by Pregabalin-associated Agranulocytosis

et al. 2014

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A 33-year-old man who had recently undergone surgery for cervical spondylotic myelopathy was prescribed pregabalin for neuralgia, and the dose was increased to 600 mg/day during hospitalization. However, the patient was diagnosed with a Clostridium difficile infection on day 34 after admission. A complete blood count showed agranulocytosis (neutrophil count: 105/μL). We did not observe any changes in vital signs, a relative increase in band cells, or intestinal edema. The patient's agranulocytosis resolved after withdrawing pregabalin. This is the first reported case of agranulocytosis associated with pregabalin. Periodic monitoring of the white blood cell count is therefore considered to be useful in patients receiving high-dose pregabalin therapy.

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“…PGB-induced hepatotoxicity has been described in limited case reports, each of which classified PGB as a probable cause of liver injury [113][114][115][116].…”

Section: Metabolismmentioning

confidence: 99%

Drug safety evaluation of pregabalin

Toth

2012

Expert Opinion on Drug Safety

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Pregabalin is a mostly well tolerated medication for the management of neuropathic pain and other conditions. Pregabalin use is associated with benign central nervous system and systemic adverse effects with very limited metabolic, idiosyncratic, or teratogenic adverse effects. Understanding of these adverse effects is essential for the clinician treating the patient and for the patient receiving treatment. Sedation, dizziness, peripheral edema, and dry mouth are the most prevalent adverse events experienced in all clinical populations. Other adverse effects are rare, but are discussed.

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Pregabalin-Induced Hepatotoxicity

Abstract: Prescribers should be alert to the possibility of idiosyncratic hepatotoxicity associated with pregabalin use.

Cited by 38 publications

References 9 publications

Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients

<i>Clostridium difficile</i> Infection Induced by Pregabalin-associated Agranulocytosis

Drug safety evaluation of pregabalin

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