MFDS orders minimized use of varenicline

recommends use of other smoking cessation therapies

Announced the ministry’s position 3 weeks into investigation… plans to take measures as soon as results come out

The Ministry of Food and Drug Safety ordered minimized use of the smoking-cessation treatment, ‘varenicline.’ The measure was announced 3 weeks after safety investigations had started for the products, from the 22nd of last month.

 

The MFDS announced that it has issued a Dear Healthcare Professional Letter regarding the precautions to take when prescribing and using smoking cessation treatment aids using ‘varenicline,’ with regards to the recall of these products abroad due to N-nitroso-varenicline impurities found in some of its products.

 

The MFDS explained that the letter was issued as a precautionary measure for domestic HCPs and patients, as the possibility of nitrosamine impurities cannot be completely ruled out, although the results of the safety investigations that started on the 22nd of June have not been released yet.

 

Measures to recall some of the finished drug products containing ‘varenicline’ are already in force in Canada and the U.S.

 

In the letter, the MFDS informed the experts and patients of the types of finished drugs and their related information.

 

To HCPs including doctors and pharmacists, the ministry recommended minimizing the use of finished drug products that contain ‘varenicline’ and asked experts to consider other treatment methods, if possible, according to the patient’s condition, until the investigation results regarding the nitrosamine impurities are announced.

 

To patients who are using affected products, the ministry advised them to continue using the treatment until the HCPs provide an alternative treatment, and to consult with doctors and pharmacists if any health concerns arise while using the medications.

 

The ministry also added that it is working closely with relevant companies to ensure that the ongoing investigation for impurities is completed as soon as possible and that it will announce measures as soon as the key results are released.

 

Also, products that do not complete testing by August 31st will be suspended from sales as a precautionary measure until it is confirmed that no impurities are detected in the products.

 

An official from MFDS said, “Public safety is of our utmost priority, and we plan to quickly implement necessary measures including completing the development of test methods for impurities and collecting and inspecting related products if necessary.” The letter was issued in the midst of the confusion arising in the field as the Korean health authorities had made no measures after ordering investigations for impurities despite ongoing product recalls for some varenicline products in the U.S.

 

and Canada.