FDA Reveals Nitrosamine Impurities in Recalled Valsartan

The 2018 Valsartan Recall

Valsartan is an antihypertensive drug that prevents heart failure by treating high blood pressure.  It has also been proven to improve a heart attack patient’s chances of survival. However, in 2018, Aurobindo Pharma USA, Inc. voluntarily recalled 80 lots of its valsartan tablets for containing traces of N-Nitrosodimethylamine (NDMA), a known carcinogenic. The recall has since become a global issue, with Canadian and European drug companies recalling any valsartan products provided by Zhejiang Huahai. Many healthcare and safety agencies, including the FDA, believe that these drugs are being tainted during the manufacturing process.

At the end of last year, the FDA issued recalls for valsartan products sold by the following drug companies:

• A-S Medication Solutions
• HJ Harkins Company
• Bryant Ranch Prepack
• AvKare
• Northwind Pharmaceuticals
• Prinston Pharmaceuticals, Inc.
• Remedy Repack
• Proficient Rx
• Teva Pharmaceuticals
• Major Pharmaceuticals
• Pharmaceutical Industries, Inc.

There have been over 40 voluntary recalls by ARB distributors in the last few months.  These recalls include three high blood pressure medications: valsartan, losartan, and irbesartan. Two months after the initial recall, Torrent Pharmaceuticals was forced to pull its valsartan drug products after detecting a second – and equally carcinogenic – impurity: N-Nitrosodiethylamine.

On May 6, 2019, Anne-Gerard Flynn, a reporter with Mass Live released an article about the valsartan recalls, reporting that a third nitrosamine impurity, N-Nitroso N-Methyl 4-amino butyric acid (NMBA) “was found in losartan manufactured by India-based Hetero Labs, prompting Camber Pharmaceuticals to recall 87 lots of losartan tablets from distribution.”

Because Zhejiang Huahai manufactures both valsartan and losartan, the FDA is rightfully concerned about the short-term and long-term safety of using these products.

The FDA Investigation

On May 2, 2019, the FDA published the results from its angiotensin II receptor blockers (ARBs) investigation. After completing rigorous laboratory tests, the FDA concluded that these drugs, including valsartan, contain unacceptable levels of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). The FDA also provided a chart that lists which products were tested during the investigation, as well as their respective NDMA and NDEA levels.

According to the FDA, “Based on FDA laboratory testing results and records from manufacturers of the recalled valsartan lots, the impurities may have been present in valsartan-containing finished drug lots for up to four years. FDA based the estimates below on the highest daily dose; however, many people may have taken lower doses, and therefore, their risks would theoretically be less.”

Schedule a Consultation Today

Contact the dangerous drug attorneys at The Ferraro Law Firm if you’ve developed a life-threatening medical condition after using valsartan or another angiotensin II receptor blocker. Our trial-tested legal team has been litigating against Big Pharma on behalf of our clients since 1985.  We also operate on a contingency fee basis, so you can pursue justice without worrying about legal fees.