What is the relationship between Augmentin (amoxicillin-clavulanate) and biliary problems, such as cholestasis or cholelithiasis?

From the Guidelines

Augmentin (amoxicillin-clavulanate) is not the preferred choice for patients with biliary problems, and alternative antibiotics should be considered to minimize the risk of worsening biliary complications. When it comes to biliary problems, the primary concern is to avoid exacerbating the condition with the wrong antibiotic choice. According to the most recent guidelines, such as those published in the World Journal of Emergency Surgery 1, the empiric antibiotic therapy for intra-abdominal biliary infections should be guided by the most frequently isolated bacteria, taking into consideration antibiotic resistance and the clinical condition of the patient. Some key points to consider in the management of biliary problems include:

• The choice of empirical antimicrobial regimen poses serious problems for the management of critically ill patients with intra-abdominal infections, and elderly patients are often frail, with infections that can precipitate organ failure 1.
• In patients with sepsis, an early correct empirical antimicrobial therapy has a significant impact on the outcome, and recent international guidelines recommend intravenous antibiotics within the first hour after severe sepsis and septic shock are recognized 1.
• The principles of empiric antibiotic therapy should be guided by the most frequently isolated bacteria, taking into consideration antibiotic resistance and the clinical condition of the patient, and alternative antibiotics such as carbapenems, piperacillin-tazobactam, or extended-spectrum cephalosporins may be more suitable for patients with biliary problems 1. It is essential to note that Augmentin can cause cholestatic hepatitis or cholestatic jaundice, particularly in older adults, males, and those on longer treatment courses, and patients with pre-existing liver disease or a history of medication-induced liver injury should inform their doctor before taking Augmentin 1. In summary, the use of Augmentin in patients with biliary problems should be approached with caution, and alternative antibiotics should be considered to minimize the risk of worsening biliary complications, and the choice of empirical antimicrobial regimen should be guided by the most recent guidelines and the clinical condition of the patient.

From the FDA Drug Label

1. 2 Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium. Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium.

Biliary Problem with Augmentin:

• Hepatic dysfunction, including hepatitis and cholestatic jaundice, has been associated with the use of amoxicillin and clavulanate potassium.
• The hepatic dysfunction, which may be severe, is usually reversible, but deaths have been reported 2.
• Hepatic function should be monitored at regular intervals in patients with hepatic impairment 2.
• The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued 2.

From the Research

Augmentin and Biliary Problems

• Augmentin, a combination of amoxicillin and clavulanate, is commonly used to treat bacterial infections, including those affecting the biliary tract 3, 4, 5.
• However, there is evidence to suggest that amoxicillin-clavulanate can cause liver damage, including cholestasic hepatitis, in some individuals 6.
• The liver damage associated with amoxicillin-clavulanate is often cholestasic in type, with a latency period of 3-4 weeks between first intake and onset of symptoms 6.
• In cases of severe cholestasic liver injury, corticosteroid therapy may be considered, in addition to discontinuation of the offending drug and supportive care 6.

Treatment of Biliary Tract Infections

• The treatment of biliary tract infections, including acute cholecystitis and cholangitis, typically involves antibacterial therapy, with coverage of Enterobacteriaceae, such as Escherichia coli, and anaerobes, such as Bacteroides spp. 3, 4, 5.
• Piperacillin, a ureidopenicillin, has been shown to be effective in the treatment of biliary tract infections, including acute cholecystitis and cholangitis 3, 4, 5.
• In severely ill patients with septicaemia, an antibacterial combination may be preferable, while in patients with moderate clinical severity, monotherapy with a ureidopenicillin, such as piperacillin, may be sufficient 3.

Biliary Strictures and Obstruction

• Biliary strictures, which can result from a variety of causes, including malignancy, can lead to clinically and physiologically relevant obstruction to the flow of bile 7.
• The goals of care in patients with a biliary stricture include confirming or excluding malignancy and reestablishing flow of bile to the duodenum, with the approach to diagnosis and drainage varying according to anatomic location 7.
• Endoscopic ultrasound-guided tissue acquisition is highly accurate for the diagnosis of extrahepatic strictures, while the diagnosis of perihilar strictures remains a challenge 7.