Pirfenidone used in the treatment of idiopathic pulmonary fibrosis (scarring of the lung tissue). It is an inhibitor of transforming growth factor (TGF)-beta (a factor which is involved in the proliferation and differentiation of cells) and it also inhibits the TNF-Alpha.

Norway health authority (Norwegian Medicines Agency) identified a new safety alert for pirfenidone from the recent case reports of severe liver damage associated with the use of pirfenidone. To minimize the occurrence of this reaction, Norway health authority released the following risk minimizing measures (RMM) to follow by health care professionals. Roche, the marketing authorization holder for this medicine with brand name ‘Esbriet’ has released a “dear health care professional letter” for dissemination of this important safety information to heath care professionals.

Risk minimization measures:

• Perform liver functions tests for identification of levels of alanine amino transferase (ALA), aspartate amino transferase (ASA) and bilirubin before initiating treatment with pirfenidone.
• Evaluate the liver enzymes for every month for the period of initial 6 months followed by once in every 3 months during the treatment duration.
• Be aware of the signs/symptoms of liver damage (fatigue, anorexia, upper abdominal discomfort, dark urine, or jaundice) and inform the same to patients to monitor for any suspiciousness.
• Suspected drug-induced liver injury: Perform clinical assessment based on the patient’s signs & symptoms and laboratory investigation values of liver function tests for early diagnosis of liver injury.
• Early action on drug administration: Consider reducing dose, or suspension or discontinuation of pirfenidone, if elevated liver enzymes are identified.

Important information for consumers:

Be aware of this drug safety alert, signs & symptoms of drug-induced liver injury for taking immediate action and early implementation of risk minimizing measures for a better patient safety.

Signs & Symptoms for potential liver damage listed below:

• Fatigue
• Anorexia 
• Discomfort in the upper abdomen 
• Dark urine 
• Jaundice 

Report any suspicious signs and symptoms to your health care professional or voluntarily report your suspected adverse drug events or reactions directly to Norwegian Medicines Agency.