Why is cabergoline banned in China? An article reveals the reason!

Cabergoline As a highly efficient dopamineD2 receptor agonist, it has long been widely used abroad to treathyperprolactinemia, especially abnormal prolactin secretion caused by pituitary adenomas. In European and American countries, such as the US FDA and the European EMA, it has been approved as a first-line drug to control pituitary prolactinoma, restore sexual function and menstrual cycle. However, in mainland China, cabergoline faces a "sale ban" status, and the reasons behind this are worthy of attention.

First of all, differences in regulatory approval mechanisms are one of the main reasons. Cabergoline was approved for clinical trials in China, but it failed to pass the approval process because the applicant company failed to meet the increasingly stringent requirements of the State Food and Drug Administration in terms of marketing application and drug safety data submission. Secondly, some studies suggest that long-term use of this drug may be associated with heart valve disease, especially when used at high doses for a long time. This risk attracted the attention of European and American drug regulatory agencies around 2010. Although subsequent studies believe that this risk is mainly related to high doses and patients with Parkinson's disease, and that the risk is minimal at lower doses required to treat hyperprolactinemia, domestic supervision is still more cautious.

In addition, market demand and alternative drugs are also a realistic consideration. Drugs such as bromocriptine currently on the market in China also have D2 agonist activity and can be used to treat hyperprolactinemia. Although the efficacy and tolerability may be slightly inferior to cabergoline, they are more mature at the regulatory level. Therefore, clinicians tend to use existing drugs, further limiting the market space of cabergoline.

It is worth pointing out that cabergoline can still be obtained legally in Hong Kong, Macao and many overseas places, and some domestic patients will use this drug through cross-border medical treatment, self-purchase, etc.

Reference materials:https://my.clevelandclinic.org/health/drugs/20863-cabergoline-tablets