Label updated for hypertension drug nebivolol

MFDS takes follow-up action on EMA safety information update… strengthens monitoring by adding risk warning

Nebivolol original ‘Nebilet’

The label for the antihypertensive drug nebivolol will now include the statement, “Beta-blockers may further increase the risk of severe hypoglycemia when co-administered with sulfonylureas (SU).”

This follows safety measures taken by the European Medicines Agency (EMA), with Korea’s Ministry of Food and Drug Safety (MFDS) moving to revise product labeling.

While concerns about hypoglycemia due to symptom masking when beta-blockers are used in combination with sulfonylureas (SU) are well known, the latest change is intended to further emphasize the severity of the risk and strengthen monitoring.

On the 6th, MFDS announced draft labeling revisions for nebivolol-containing products and will collect feedback through the 21st.

This draft is based on safety information from the European Medicines Agency (EMA). Nebivolol is a third-generation beta-blocker.

According to the proposed amendment, the following statement will be added to the General Precautions section: “Beta-blockers may further increase the risk of severe hypoglycemia when co-administered with sulfonylureas. Patients with diabetes should be advised to carefully monitor their blood glucose levels.”

Additionally, the following statement will be added to the “Drug Interactions” section. “Concomitant use of beta-blockers and sulfonylureas may increase the risk of severe hypoglycemia.”

Current labeling already advises caution when administering the drug to patients with diabetes. This is because beta-blockers, including nebivolol, can mask specific symptoms of hypoglycemia, such as tachycardia and palpitations,

As a result, patients may fail to recognize hypoglycemia and progress to severe hypoglycemia.

Consequently, this may increase the likelihood that patients will progress to severe hypoglycemia without recognizing the symptoms.

The Interactions section currently also includes a statement that co-administration with insulin or oral antidiabetic agents may mask specific symptoms of hypoglycemia (palpitations, tachycardia).

However, the current labeling does not specifically warn against co-administration with sulfonylureas (SU) among antidiabetic agents.

Last year, the EMA reviewed evidence suggesting that the risk of severe hypoglycemia may increase when nebivolol is used in combination with sulfonylureas and required that this information be added to the product label.

MFDS appears to have prepared the Korean revision as a follow-up measure to the EMA’s actions.

Currently, there are 25 nebirol-containing products approved in Korea. These include the original “Nebilet Tab” (Menarini Korea), the low-dose “Nebilet M Tab” (Kwangdong Pharmaceutical), and the nebirol-rosuvastatin combination drugs “Nebirosta Tab” (Elyson Pharm) and “Crebista Tab” (Arlico Pharmaceutical).

According to UBIST, Nebilet recorded KRW 8.6 billion in outpatient prescriptions last year.