“No changes in safety and efficacy of montelukast”

Director Kim Chang Geun of Inje Uniersity Sanggye Paik Hospital “The side effect is nothing new”

Reaction to FDA Boxed Warning “It would be rather safer than steroid”

Medical academics argue there is “no change in safety and efficacy of montelukast,” currently controversial with safety risk.

 

Professor Kim Chang Geun (Director of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center and President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease)

Director Kim Chang Geun of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center spoke on Mar.

 

9 at a roundtable with press.

 

The President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease (KAPARD), Director Kim stressed “The neuropsychiatric event from montelukast has been labeled on the drugs since 2008, which the prescribers are already aware of.” On Mar.

 

4, the U.S.

 

Food and Drug Administration (FDA) has announced it would require Boxed Warning on montelukast products, including Singulair and generics.

 

The U.S.

 

health authority took the action after learning many healthcare providers, patients and caregivers are unaware of mental health side effect, such as anxiety, depression, sleep disorder and suicidal thoughts.

 

FDA also recommended the drug would be used for “only patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies.” Montelukast is vastly used for patients with asthma and allergy.

 

The used volumes in Korea and Japan are particularly high.

 

Although the alternative options advised by FDA are inhaled steroid and antihistaminic medicines, Professor Kim Chang Geun explains the use of those options would highly unlikely in Korea.

 

Following is his answers to interview questions.

 

-How are patients and caregivers reacting to the news?

 

“A patient asked about the warning and if it would be okay to use it.

 

I answered there is no specific change to the drug’s state of safety or efficacy.

 

The said side effects are not newly discovered.

 

Rather, the medications have been used for over two decades.

 

I reminded the patient to read about the listed side effects carefully.” -Please explain how has treatment for allergic rhinitis been prescribed so far “Montelukast was the go-to medicine.

 

Depending on the symptoms, other medicines were added.

 

Antihistaminic agent was prescribed for serious sneezing, and steroid was prescribed for serious nasal congestion.

 

And if the allergic antigen was clear, then immunotherapy was provided as well.” -Basically, the FDA’s announcement recommended montelukast as a second-line treatment for mild case of allergic rhinitis.

 

Could it affect the trend of prescription on mild case of allergic rhinitis?

 

“The FDA announcement could be summarized to two points; think twice before prescribing the medication to patients with asthma and select other alternative for patients with mild allergic rhinitis.

 

The key is prescription for rhinitis.

 

FDA mentioned three medicines for alternative options—antihistaminic agent, inhaled steroid, and immunotherapy.

 

“Personally, the tendency of my prescription would not change.

 

We do not have that many options to choose from.

 

Patients and caregivers are highly resistant to inhaled steroid in Korea.

 

Healthcare providers also tend to steer away from it, because we are aware of even worse side effects.

 

Antihistaminic medicines are hardly a treatment.

 

And immunotherapy is for limited use only.” -How about leukotriene receptor antagonist instead of montelukast?

 

“Pranlukast would be an option.

 

But it hasn’t got the U.S.

 

FDA approval, yet.

 

Developed from Japan, the medicine is used in Japan, Korea, China, Turkey and Mexico, as far as I know.

 

I heard of zileuton and zafirlukast.

 

But technically, they have not been used at clinical scenes.” -Considering the medicine is indicated to treat pediatric patients over age one, should the parents with young patient worry more about it?

 

“Along with the official statement, FDA has attached a related research result.

 

It compared side effect prevalence between montelukast and inhaled steroid used to treat patients over six.

 

The result is that there is not much difference found between those two.

 

It is not easy to evaluate patients aged one to five.

 

But, with my 20 years of experience in the clinical scene, I have not found such side effect.” -What do you make of the FDA’s decision?

 

“I’m not trying to defend the medication.

 

But what I can assure is that it does not mean a new side effect has been reported.

 

The point of the action was to highlight the neuropsychiatric side effect, labeled since 2008 to be exact, for healthcare professionals and patients to be aware of it.

 

There is no change in the medication’s safety or efficacy.

 

The clinical professionals are well-aware of the side effects.

 

I assume the medication could be used without a problem, as it has been to this date.

 

“Moreover, FDA said the cause and effect has not been clarified, yet.

 

It only stated such case has been reported.

 

So a patient suffering from neuropsychiatric side effect has used montelukast, but it wasn’t the only prescribed medication.

 

It could have been the steroidal medication that caused the event.

 

The disease itself tends to affect mental health as well.

 

Regardless of the prescription, patients complain of anxiety and depression.”