USFDA issued a drug safety communication for the restricted use (new contraindication) of Ocaliva (obeticholic acid) in patients with advanced cirrhosis due to the risk of serious liver failure (sometimes requiring liver transplant).

Ocaliva is a prescription medicine which is used in the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid. It acts by decreasing alkaline phosphatase (ALP) levels in blood and improves patient from disease related symptoms and survival.

Current clinical evidence demonstrates that benefit-risk profile for this medicine is positive/favorable for patients without advanced cirrhosis. Advanced cirrhosis is defined as cirrhosis with current or prior evidence of acute deterioration of patient’s liver function with cirrhosis which is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal haemorrhage or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia).

25 case reports were identified by USFDA including the available relevant medical literature which reported the serious liver injury leading to liver decompensation/liver failure associated with Ocaliva in PBC patients with cirrhosis.

Important information for patients/patient care providers;

To be aware of this information and inform any your healthcare provider about your complete medical history/concurrent medical conditions which helps in appropriate assessment of benefit-risk profile before prescribing this medicine.

Be cautious about the below specific and generalized signs/symptoms and if noticed, report immediately to your respective physician/healthcare professional.

Specific symptoms

  • Swollen belly
  • Yellow eyes or skin
  • Bloody or black stools
  • Coughing up or vomiting blood
  • Mental status changes such as confusion, slurred speech, mood swings, changes in personality, or increased sleepiness or difficulty waking up

General symptoms (if they are severe or do not go away after a few days)

  • Belly pain
  • Nausea, vomiting, or diarrhea
  • Loss of appetite or weight loss
  • New or worsening tiredness
  • Weakness
  • Fever and chills
  • Lightheadedness
  • Less frequent urination

Important information for Healthcare professionals:

Be aware of this new contraindication of Ocaliva (obeticholic acid) in patients with advanced cirrhosis and prescribe/dispense this medicine only based on favorable benefit-risk ratio in the context of individual patient’s medical condition (specifically liver condition).

Routinely monitor patients for any clinically significant liver-related adverse drug reactions that could be manifested as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.

Discontinue this medicine permanently in patients developing the above symptoms.

Report any suspected adverse drug reactions associated with the use of this medicine to national ADR reporting system.

Voluntary ADR reporting

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the postmarketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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