Is MFDS going to suspend sales on nizatidine with no NDMA?

Industry urges sales suspension to be more selective based on NDMA level

MFDS orders nizatidine usage record by each DMF number

Nizatidine with NDMA found in Japan and the U.S.

Pharmaceutical industry is walking on thin ice as the government initiated impurity investigation on stomach ulcer medicine.

 

Now that the U.S.

 

detected impurity in nizatidine, following a case in Japan, probability of finding impurity in nizatidine has gotten higher in Korea.

 

The industry is on high alert against the government’s possible order to suspend sales of nizatidine drug without detecting any impurity, which was the case with ranitidine.

 

According to an industry insider, Ministry of Food and Drug Safety (MFDS) ordered pharmaceutical companies to submit complete nizatidine product manufacturing record and to test active pharmaceutical ingredient (API) chemically similar to the ingredient.

 

MFDS ordered companies to submit API usage record and other archived evidences to confirm manufacturing record until Nov.

 

4.

 

The ministry seems to be investigating uses of all complete product with both Korean-made and imported nizatidine Nizatidine is an H2-receptor antagonist similar to ranitidine suspended of sales from last September.

 

After deciding to suspend sales of all ranitidine drugs, MFDS also set a plan to investigate similar APIs, starting with nizatidine first.

 

Ministry’s nizatidine usage record investigation resembles that of ranitidine’s.

 

On last Sept.

 

20, MFDS directed pharmaceutical companies to investigate ranitidine API usage record, and six days after on Sept.

 

26, the ministry announced sales suspension on all ranitidine items.

 

The industry presumes MFDS is about to announce nizatidine investigation result based on the precedent case.

 

And now, the industry is nervously waiting for the ministry’s decision on nizatidine items.

 

.Possibility of finding N-Nitrosodimethylamine (NDMA) has been raised at home and aboard, already

 

.A private U.S.-based research institute, Valisure unveiled their testing report on nizatidine last September and stated they have detected NDMA

 

.Previously, Valisure proposed regulators to recall ranitidine as it detected excessive level of NDMA in the API

 

.Their latest report state researchers found one-seventieth of NDMA in ranitidine was detected in nizatidine

 

.Japanese Ministry of Health, Labour and Welfare announced Japan-based Ohara Pharmaceutical tested their nizatidine product and detected NDMA exceeding the accepted level

 

.The ministry reported the company decided to voluntarily recall their products due to the issue

 

.On Nov

 

.4, the U.S

 

.Food and Drug Administration (FDA) released a statement about their investigation on NDMA found in ranitidine, and stated four nizatidine items from two companies had NDMA

 

.However, the said nizatidine drugs had NDMA within the accepted level and were not included in the voluntary recall subject group

 

.Some of pharmaceutical companies in Korea are promoting that their nizatidine drugs are NDMA free

 

.However, some have raised concern about possibility of detecting NDMA in nizatidine ingredient used in Korea

 

.At the moment, total nine API manufacturing plants have been registered to produce nizatidine

 

.Korean Medical Association (KMA) has already advised doctors to refrain from prescribing nizatidine

 

.In last month, KMA official said “The recent ranitidine incident has created a social turmoil, so the organization advised members to refrain from prescribing nizatidine containing drugs until MFSD announces final investigation result and its further action”

 

.Pharmaceutical companies are keeping a close eye on MFDS’ further action for when finding minuscule amount of NDMA in nizatidine

 

.The companies are afraid of the ministry ordering sales suspension on all nizatidine drugs for questionable cases of NDMA not detected from most of the complete product, and a single manufacturing unit containing minuscule amount of NDMA exceeding acceptable level

 

.As for ranitidine drugs, all seven manufacturing plants had NDMA surpassing acceptable level in the API, but each item manufactured in a same plant had different levels of NDMA

 

.For instance, some ranitidine drugs manufactured from one plant were found with unacceptable level of impurity and others were not

 

.

Result of NDMA investigation on collected ranitidine API (Source: MFDS)

At the time, MFDS official stated “After collecting issue API and investigating them, each registered items from one manufacturing plant had different levels of NDMA and similar cases have also been found in other countries”

 

.After making the statement, the ministry ordered sales suspension on all ranitidine drugs, judging that ranitidine itself is too unstable to be consumed

 

.A pharmaceutical research institute, UBIST reported last year’s volume of nizatidine drug prescription for outpatient reached 25.9 billion won

 

.Although it would be about one tenth of the ranitidine market, some pharmaceutical companies are faced with serious damage from sales suspension on popular nizatidine products

 

.Pharmaceutical companies continue to urge the Korean regulators to suspend sales limited to items exceeding acceptable NDMA level like the case in the U.S

 

.Some of the industry is also questioning credibility of the NDMA testing methodology as same API has been detected with different levels of NDMA

 

.A pharmaceutical industry insider stressed, “MFDS has decided to suspend sales on valsartan and ranitidine drugs, regardless of each sample showing different level of the carcinogen

 

.The regulators should use more precise investigative methodology and limit penalty to items with exceeding level of NDMA only”

 

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