TEHRAN- An official with the Iranian Food and Drug Administration announced that the blood pressure medications in Iran do not contain impurities that could cause cancer, IRNA reported on Tuesday. 

The announcement was made after the United States Food and Drug Administration (FDA) recalled losartan, a blood pressure medication, over concerns that it might cause cancer.

According to FDA, the losartan lot being recalled was found to be contaminated with trace amounts of an impurity, N-nitrosodiethylamine (NDEA). 

NDEA is an organic chemical that is classified as a probable human carcinogen and is used to make liquid rocket fuel. It’s also a byproduct of pesticide manufacture and fish processing.

“We have inspected all different losartan products in the market and only one series of the product was considered as dangerous and it was subsequently recalled.”
After the announcement, two major suppliers of the drug in United States, Sandoz Inc and Torrent Pharmaceuticals voluntarily recalled the drug from the market in August and December 2018, and then another patch in March 2019. 
Losartan affected by the recall are 100 milligram/25 milligram tablets with the lot number JB8912.

According to Mohammad Abdzadeh, the director of drugs department at the Iranian Food and Drug Administration, only the 360 mg losartan with certain raw materials are dangerous, but the ones available in Iran’s market are safe. 
“We have inspected all different losartan products in the market and only one series of the product was considered as dangerous and it was subsequently recalled,” said Abdzadeh.  

Valsartan recall in Iran 

In July 2018, FDA warned about another blood pressure medication, Valsartan.

This recall was due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing Valsartan were recalled. 

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

The contaminated Valsartan was majorly supplied by a Chinese company, Zhejiang Huahai Pharmaceuticals which was also a distributor of the drug among five other companies; namely the Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries Ltd, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

Following the concerns over the quality of Valsartan in Iran, Fereidun Noohi, head of the Iranian Heart Association, announced that all Valsartan products in Iran are standard and do not pose any risks to the people. 

According to Young Journalists Club, after the FDA announcement in July, all the Valsartan products in Iran that contained the impurity were recalled. They were distributed in Iran by seven Iranian companies and one foreign supplier. 

SJ/MQ/MG