FDA Expands List of Blood Pressure Medications Recovered for Potentially Carcinogenic Ingredient


Torrent Pharmaceuticals has issued its fourth Losartan recall since December, after potentially carcinogenic impurities were found on high blood pressure medication. The FDA is advising patients to consult pharmacists and doctors about alternatives. ( Steve Buissinne | Pixabay )

Torrent Pharmaceuticals Limited has issued a voluntary recall of its losartan potassium and losartan potassium / hydrochlorothiazide tablets due to a possible cancer-causing impurity.

The US Food and Drug Authority made the announcement on Thursday, April 18. A complete list of all the remedies collected is available on the federal government's website.

Recovered Blood Pressure Drugs

The impurity found in the active pharmaceutical ingredient, or API, is N-methylnitrosobutyric acid or NMBA. The chemical has been marked as a carcinogenic potential for humans.

Torrent Pharmaceuticals received no complaints of adverse side effects. However, the company voluntarily withdrew 36 batches of losartan potassium and 68 batches of losartan potassium / hydrochlorothiazide tablets containing levels of impurities that are higher than the FDA considers to be the acceptable daily amount.

Losartan is commonly prescribed for patients with high blood pressure or as a treatment for patients with type 2 diabetes with nephropathy. While the recall is currently in effect, the FDA recommends that patients who have been prescribed with the affected medication continue to take the medications. They warned that stopping treatment abruptly could cause more serious health problems.

The agency encourages the public to consult a pharmacist or doctor about alternatives before making changes to their regular treatment.

Product Recall

This is the fourth recall issued by Torrent Pharmaceuticals since December. Two more product recalls were announced in January and March for possible cancer-causing impurities.

The recent FDA notice is related to the valsartan recall that were expanded several times last year. In July, the agency alerted patients and health professionals about the API, which also contains NDMA, another ingredient that can cause cancer.

In September, the FDA placed the Zhejiang Huahai Pharmaceuticals on import alert "to protect US patients". The Chinese company manufactured the APIs on drugs that were collected last year due to impurities.

In November, the FDA issued warning letters to the company for failing to address the carcinogenic impurity in the APIs after a customer complained in 2016. The agency also found that the company deviated from good manufacturing practices that led to the formation of impure.

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