"Rheumatoid Arthritis Treatment 'Tofacitinib' and Increased Risk of Heart Attack"

[Asia Economy Reporter Seo So-jung] The Ministry of Food and Drug Safety (Minister Kang-lip Kim) announced on the 3rd that it has distributed a "Drug Safety Letter" stating that three active ingredients?topacitinib, baricitinib, and upadacitinib?used for the treatment of rheumatoid arthritis and other conditions may increase the risk of severe heart-related diseases such as heart attacks.

The three active ingredients, including topacitinib, are Janus kinase (JAK) inhibitors used to treat chronic inflammatory diseases such as arthritis or ulcerative colitis. A total of 51 products (from 46 companies) are approved in South Korea.

Topacitinib includes 48 products from 44 companies, such as 'Xeljanz' by Pfizer Korea. Baricitinib includes 2 products from 1 company, such as 'Olumiant' by Eli Lilly Korea, and upadacitinib includes 1 product from 1 company, such as 'Rinvoq' by AbbVie Korea.

This safety letter was prepared after reviewing the letter from the U.S. Food and Drug Administration (FDA) and determining that it is necessary to provide related safety information to domestic medical experts and consumers.

On the 1st, the U.S. FDA announced a letter stating that it plans to add a boxed warning about increased risks of severe heart diseases, cancer, thrombosis, and death for the three JAK inhibitors?topacitinib, baricitinib, and upadacitinib?used to treat rheumatoid arthritis.

The Ministry of Food and Drug Safety stated, "We plan to promptly take necessary safety measures by reviewing the approval status, usage, and actions taken domestically and internationally, including in Europe and the U.S., and by consulting experts. Medical institutions in Korea must verify this safety information when administering these active ingredients to patients."

This content was produced with the assistance of AI translation services.