241 items of the impurity detected Losartan were recovered

Some of the 54 items were recovered. Hanmi's current items will be sold as it is

Azido impurities are detected in Losartan, HTN treatment , and all 241 items are recovered, and only some manufacturing numbers of 54 items are recovered.

 

However, 11 items are sold as they are because impurities are not detected excessively.

 

The MFDS explained that the risk of harm to the human body is very low, but in the case of patients, it is possible to exchange products, be re-prescribed, and be re-dispensed.

 

It has been decided that Hanmi Pharmaceutical products can be sold.

 

The MFDS announced on the 7th that as a result of a safety survey on impurities in the middle of the drug containing Lozartan, which is a treatment for hypertension, the daily intake allowance (1.7~88.7㎍) was exceeded (1.5㎍/day), but concerns about human harm were very low.

 

This impurity is an Azido impurity that occurs specifically in Losartan, and its mutagenicity (genetic mutation-causing property) has been confirmed and carcinogenicity has not been confirmed.

 

It is explained that the impurities of the Losartan product are different from the impurities AZBT identified among Sartan products in September, and the safety survey was conducted according to the safety information of medicines such as overseas recovery.

 

As a result of the safety survey, all or some lot number products of 295 items (98 companies) that are feared to exceed or exceed the daily intake allowance of Losartan impurities out of 306 items (99 companies) in circulation are voluntarily recovered by pharmaceutical companies.

 

It is voluntarily being recovered from the pharmaceutical company.

 

However, the MFDS confirmed that all or some of the 65 items (23 products) are within the daily intake allowance, and from December 1, only products with less than the allowable amount of Losartan impurities have been shipped.

 

Patients taking Losartan should not stop taking it arbitrarily, but should decide whether to continue taking it after consulting with a doctor or pharmacist.

 

It is explained that if necessary, it can be ▲exchanged for a different manufacturing number ▲ or re-prescribed and re-dispensed with another product.

 

The MFDS consulted the Central Pharmaceutical Review Committee to set the daily intake of Azido impurities, and applied the International Guidelines (ICHM7) in the pharmaceutical sector to set it at 1.5//day.

 

ICHM7 sets a "negligible level" as a daily intake allowance for mutagenic impurities that have not been confirmed to be carcinogenic when consumed daily for life (70 years).

 

As a result of evaluating the health effects of most patients who took Losartan, which daily intake allowance of Losartan impurities was excessively detected, it was found that 0.54 out of 100,000 people had a very low possibility of developing additional cancer, which was negligible.

 

It is explained that the human impact assessment of patients taking excess impurities detection products of Losartan was conducted according to ICHM7 by comprehensively considering ▲ the HIRA's prescription data for the past six years ▲ the maximum dose per day ▲ impurity test results.

 

The MFDS stressed that patients prescribed the product should not arbitrarily stop taking drugs because taking Losartan, which exceeds the daily intake of impurities, has little impact on health.

 

However, patients with health concerns visited the hospital where the drug was prescribed and asked the medical staff to consult whether they were taking the drug and the need to re-prescribe it.

 

They can be exchanged for another lot number by visiting a pharmacy they previously prepared without visiting a medical institution, and patients wishing to re-prescribe can be re-prescribed and re-dispensed with other hypertension treatments.

 

In the case of re-prescribing, re-dispensing, or exchanging medicines at hospitals, clinics, or pharmacies that have previously been prescribed or dispensed, patient compensation is exempted only once for the first time.

 

It will support the use of the health insurance claim system for smooth cost settlement between nursing institutions and pharmaceutical companies.

 

An official from the MFDS emphasized, "We will continue to strictly manage only Losartan, which is less than the daily intake allowance, to supply safe and effective high-quality medicines based on scientific knowledge and regulatory expertise."