Taiwan restricts prescription of drugs containing montelukast

Taiwan's Food and Drug Administration (FDA) has decided to impose restrictions on the prescription of drugs containing montelukast for patients suffering allergic nose inflammation, ruling that such medications should only be prescribed after other drugs have been used and failed to be effective.

In a statement released Tuesday, the FDA explained drugs containing montelukast could cause side effects that threaten the mental health of patients, such as behavior changes, unusual movements, or having suicidal thoughts, as they are taking the medication or after treatment has stopped.

Hung Kuo-teng (???), head of the FDA's Medicinal Products Division, told reporters that there are 31 drug permit licenses that had been issued in Taiwan for drugs containing montelukast, which is used to treat asthma and allergic rhinitis, a type of inflammation in the nose that occurs when the immune system overreacts to allergens in the air.

Citing health insurance data, Hung said that each year, around 900,000 prescriptions of medication containing montelukast were given in the nation for the treatment of ailments including allergic rhinitis and asthma.

Last year, the United States Food and Drug Administration issued a warning against such drugs, indicating that their clinical effectiveness was not shown to be greater than the potential risk they posed to patients' mental health.

It then determined that their use should be prevented until any other medications for allergic rhinitis have been used and found to be ineffective, according to Hung.

In light of the warning, Taiwan's FDA re-evaluated the effectiveness and risk of such medications, and its drug safety assessment panel then determined that drugs containing montelukast are effective in treating allergic rhinitis but may also cause their users to develop mental health problems, Hung said.

As a result, the FDA has decided to list those medications as "rear-line" drugs, meaning they will only be prescribed when other medications for allergic nose inflammation have failed to be effective, Hung said, noting that there are other drugs for treating asthma.

With the ruling taking effect immediately, Hung also said that the companies which hold drug permit licenses for these drugs were told to change the content of the drugs' package inserts before July 31, 2022, so that it would state that the drugs can only be used when other drugs treating allergic rhinitis have failed to be effective.

For companies which fail to make the change before the deadline, their drug permit license will be voided, Hung said.

Source: Focus Taiwan News Channel