No recall crisis expected to arise from losartan impurities

due to low risk and complicated exchange method

The MFDS recalled 295 losartan items that were detected with impurities

Possibility of cancer at an dismissable level.. patients should not discontinue administration of the drugs

Although 295 antihypertensive treatments that were found with impurities were ordered recalled, due to the low risk and specificity of the targeted items, no disruption is expected from the exchange, re-prescriptions, or re-dispensing of such drugs.

 

The Ministry of Food and Drug Safety announced on the 7th that 295 losartan items that were found to contain azido impurities that exceed the allowed daily intake of 1.5㎍/day (1.7~88.7㎍/day) will be recalled.

 

However, the ministry emphasized that the risk of its harm to the human body is very low and that the patients should not discontinue taking the drugs.

 

The azido impurities that were detected this time occur specifically in the losartan ingredient, and although the properties of genetic mutations have been confirmed in the ingredient carcinogenicity has not been yet identified.

 

In particular, an assessment of its health effect on the majority of patients who took losartan that had an excess amount of impurities than the allowed daily intake showed that the added risk of cancer from the impurities was 0.54 out of 100,000, which was a very low and negligible level.

 

An MFDS official said, “The evaluation was based on the representative value (median value) that was set with losartan drugs that had impurities exceeding the amount allowed for daily intake.

 

We also took into account the possibility that the drugs that had a higher amount of impurities will be taken for life (70 years).” As a result, the MFDS emphasized that even if one takes losartan drugs that contain an excess amount of impurities, it has little effect on one’s health, and that patients who were prescribed the product should not arbitrarily discontinue taking the drugs.

 

However, the exchange, re-prescriptions, or re-dispensing measures were prepared to resolve anxiety for patients with health concerns.

 

The exchange, re-prescriptions, or re-dispensing of the drugs can be done at no out-of-pocket cost on the patient’s part.

 

However still, the number of re-prescriptions or re-dispensing is not expected to be high.

 

Although all lot numbers of 241 items will be fully recalled, only some lot numbers of 54 items and none from 11 items are recalled, and identifying the drugs that are subject to recall is also a complicated process.

 

Also, some of the items for which full recalls are being conducted for all lot numbers, some are being re-released as normal items, and may only be exchanged at hospitals rather than be re-prescribed or re-dispensed at hospitals.

 

In fact, only 4 cases of consumer exchanges arose for sartan drugs that were recalled due to excess impurities in September.

 

Due to this, there had been some criticism that the authorities had wasted too much time on the consumer exchange process that did not have many actual cases, delaying the recall period for the harmful drugs in business.