Brigette Honaker  |  March 8, 2019

Category: Legal News

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Two pharmacists read a prescription.The valsartan impurities recall continues to grow, with 126 more lots recalled by three companies.

The products are distributed by AurbindoPharma USA, Acetris Health LLC, and Camber Pharmaceuticals Inc., according to the announcement by the U.S. Food and Drug Administration (FDA). Losartan and valsartan tablets are part of the recently recalled lots.

This recall is the most recent episode in a wave of recalls affecting blood pressure medications, triggered by the discovery that they could have been tainted with carcinogens for years.

On March 1, AurbindoPharma announced that it would recall 38 lots of its blood pressure medications, including valsartan tablets and tablets of valsartan combined with amlodipine. These products are reportedly distributed by both AurbindoPharma and Acetris.

According to the recall notice, the 40mg, 80mg, 160mg, and 320mg blood pressure medication tablets may contain trace amounts of N-nitrodiethylamine (NDEA). A full list of affected lot numbers is available on the FDA’s announcement page.

“Patients who [are] prescribed Amlodipine Valsartan Tablets USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the FDA announcement states. “Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.”

NDEA is an impurity found in certain foods, drinking water, air pollution, and industrial processes. The International Agency for Research on Cancer (IARC) has reportedly classified this substance as a probable human carcinogen.

Camber Pharmaceuticals also announced a recall on Feb. 28 involving 87 lots of their losartan medications. The FDA says that recall affects 25mg, 50mg, and 100mg tablets in 30 count, 90 count, 500 count, and 1000 count bottles. Trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) were found in the medications.

“NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall,” the FDA notes.

According to the pharmaceutical company, the active drug ingredient for the Camber losartan tablets was manufactured in Hetero Labs Limited. This Indian drug factory is one of two overseas locations linked with valsartan impurities and the recalls that began last July.

Both NDEA and NMDA may cause cancer in high doses, according to scientific research. NDEA is classified as a probable human carcinogen and NMDA, which has been shown to cause bladder cancer in rats, is classified as a known animal carcinogen and a potential human carcinogen. Testing of the recently recalled blood pressure medications has reportedly shown that the losartan impurities exceed the interim acceptable intake limits set by the FDA.

The potential risk for exposure to cancer causing ingredients may be the nail in the coffin for drugs like valsartan, considering some of their known side effects. Valsartan is reportedly associated with liver damage and liver toxicity, which may resolve after stopping the medication. Signs of liver damage include jaundice, abdominal pain, enlargement of the liver, nausea, and pruritic erythematous skin changes.

As the FDA states, consumers should consult with their doctors before stopping their valsartan blood pressure medications. Untreated high blood pressure can increase the chance of life threatening complications, so a medical professional should be consulted so that another treatment plan can be determined.

If you developed cancer or severe liver damage after taking valsartan, you may benefit from joining a free valsartan lawsuit investigation. Fill out the FREE form on this page for more information.

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