The U.S. Food and Drug Administration has announced another voluntary recall of a blood pressure medication. Tests showed the drug losartan potassium hydrochlorothiazide contains trace amounts of n-Nitrosodiethylamine (NDEA), a potentially cancer-causing chemical.
Sandoz issued the voluntary recall after receiving notification from the FDA about the presence of NDEA. The recall affects 100 milligram/25-milligram tablets. At this time, it does not involve other versions of the drug, sometimes sold under the brand name Hyzaar.
For patients with high blood pressure taking Sandoz’s losartan potassium, the FDA recommends looking at the bottle to check the lot number. If your bottle has a lot number JB8912, then you have the recalled pills.
The FDA recommends that all patients keep taking their blood pressure medication until they get a replacement or alternative treatment option before they stop taking any prescribed medication.
What is NDEA?
This recall is just one in a slew of ongoing carcinogen related recalls in blood pressure medication. The FDA has also found n-Nitrosodimethylamine (NDMA) in blood pressure medications, most notably valsartan. Both NDEA and NDMA are suspected human and animal carcinogen that is used in rocket fuel and as a lubricant additive.
NDEA is an organic compound used in gasoline, lubricant additive, antioxidant and stabilizer for industrial materials. When heated to decomposition, the chemical emits toxic fumes. Both the Environmental Protection and the World Health Organization classify the chemical as a carcinogen.
What is Losartan?
Losartan Potassium is a chemical compound used to treat hypertension. In addition, the ingredient helps protect the kidneys from damage due to diabetes. The drug is an angiotensin II receptor blocker that helps in lowering the risk of strokes in patients with high blood pressure and an enlarged heart.
According to a press release from the FDA, Zhejiang Huahai Pharmaceutical Company Co. Ltd. supplied Sandoz the active ingredient for the drug. Notably, Zhejiang has been under an import alert since the end of September 2018. An import alert forbids any of the Chinese company’s drugs from entering the United States. The FDA made this decision after an inspection of the facility.
How does the Losartan recall relate to the Valsartan recall?
Several high blood pressure medications containing valsartan have been under recall since July. The valsartan recall came after tests showed the drugs to contain n-Nitrosodimethylamine (NDMA), a probable human carcinogen. The FDA became aware of the issue after lab testing discovered the unexpected presence of the chemical in valsartan—the active ingredient.
NDMA and NDEA can occur unintentionally during the manufacturing process of losartan and valsartan.
The Carlson Law Firm Can Help
The Carlson Law Firm has more than 40 years of experience representing clients injured by dangerous drugs. In addition to medical bills, these drugs can cause other losses in your life such as wage loss, a decline in quality of life and in particularly egregious situations, loss of life.
Call our firm today to speak with a qualified and knowledgeable products liability attorney at The Carlson Law Firm. Consultations with The Carlson Law Firm are free. There is no obligation. Contact us to discuss your situation with a qualified Dangerous Drug Attorney.
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