Olmesartan: Risk of Autoimmune Hepatitis
Drug Safety Update
Olmesartan is an angiotensin II receptor antagonist indicated for the treatment of essential hypertension.
Based on the evidence from the literature and EudraVigilance, the European Medicines Agency (EMA) concluded that there is a plausible causal association between olmesartan and autoimmune hepatitis. Hence, an update to the product information for all olmesartan-containing products was compelled by the EMA in January 2022.
The time to onset of drug-induced autoimmune hepatitis is often more than 6 months, but can sometimes be up to several years after initiating the drugs.
Recommendations
Advise patients to seek medical attention immediately if they develop signs and symptoms such as yellowing of the whites of the eyes, dark urine, or skin itchiness, even if they have been taking olmesartan for a long period of time.
Consider the possible role of omelsartan in patients with clinical symptoms, unexplained liver enzyme elevations, and laboratory findings suggestive of autoimmune hepatitis.
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