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Recall: Heart Drugs Contain Carcinogens

Bloomberg reports that dozens of lawsuits have been filed against drug makers and sellers over widely prescribed generic heart medications tainted with potential carcinogens. A recall overseen by the U.S. Food and Drug Administration involved drugs used to treat high blood pressure, heart failure and other conditions. The lawsuits allege the plaintiffs were prescribed the medications and developed cancer according to filings in the U.S. District Court in New Jersey. In July 2018, the carcinogen NDMA was discovered in valsartan manufactured by Zhejiang Huahai Pharmaceutical Co.

Other drugs that are similar to valsartan—losartan and irbesartan—have also been recalled. The contaminated valsartan was sold to a number of major drugmakers and used as an ingredient in other popular cardiovascular therapies. Other companies named in the complaints include generic-drug giants Teva Pharmaceutical Industries Ltd. and Mylan NV, as well as CVS Health Corp., which operates large pharmacy and drug-benefit management businesses. The FDA estimates that the pills may have been contaminated with NDMA for as long as four years before the problem was found.
The number of patients, if any, who developed cancer as a result of taking valsartan is unknown.A separate class action was filed with the New Jersey court on April 5 on behalf of patients who may not exhibit symptoms until years from now. Those patients took contaminated valsartan and may have sustained cellular damage, suffered genetic harm or developed cancer but haven’t yet been diagnosed, according to the complaint. The suit seeks to create a fund to finance independent medical monitoring, including examinations and preventive screening, and provide cancer treatment.
All the cases have been combined before Judge Kugler in federal court in Camden in multi-district litigation, where he will oversee selection of plaintiffs’ leadership, pretrial motions and evidence-gathering, as well as any initial trials. U.S. District Magistrate Judge Joel Schneider plans to order the defendants to produce all FDA inspection reports related to facilities that manufacture valsartan dating back to 2010. He also asked the companies to produce any communications they had with the FDA about how carcinogens got into the drugs.The cases are consolidated: In Re: Valsartan Products Liability Litigation, 19-md-02875, U.S. District Court, District of New Jersey (Camden).Do NOT stop taking your prescription drugs without consulting a doctor and obtaining approval. The FDA recall notice includes the following:

Date Brand Name Product Description Reason/ Problem Company
03/01/2019 Aurobindo, Acetris Valsartan and Amlodipine and Valsartan tablets Contains N-nitrosodiethylamine (NDEA), AurobindoPharma USA, Inc.
12/31/2018 Aurobindo Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP Undeclared N-nitrosodiethylamine (NDEA) Aurobindo Pharma USA, Inc.
12/04/2018 Mylan Valsartan-containing products Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient Mylan Pharmaceuticals
11/27/2018 Teva Pharmaceuticals Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets Impurity N-nitroso-diethylamine (NDEA) in API Teva Pharmaceuticals
11/20/2018 Mylan Amlodipine and Valsartan Tablets; Valsartan Tablets; Valsartan and Hydrochlorothiazide Tablets Contain trace amounts of an impurity, N-nitrosodiethylamine (NDEA) Mylan Pharmaceuticals
08/23/2018 Torrent Pharmaceuticals Limited Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets Impurity detected in the API is N-nitrosodimethylamine (NDMA) Torrent Pharmaceuticals Limited
08/17/2018 Torrent Valsartan/Amlodipine/HCTZ Tablets Impurity detected in the API is N-nitrosodimethylamine (NDMA) Torrent Pharmaceuticals
08/08/2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Detection of trace amounts of N-Nitrosodimethylamine (NDMA) Camber Pharmaceuticals, Inc.
07/17/2018 Actavis Valsartan and Valsartan Hydrochlorothiazide Tablets Impurity detected in the API is Nnitrosodimethylamine (NDMA) Teva Pharmaceuticals USA
07/17/2018 Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg Detection of a Trace Amount of Unexpected Impurity, N- nitrosodimethylamine (NDMA) Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
Date Brand Name Product Description Reason/ Problem Company
07/13/2018 Major Pharmaceuticals Valsartan tablets, 80mg USP and 160 mg USP may contain the probable carcinogen Nnitrosodimethylamine (NDMA) Major Pharmaceuticals

CONTACT US

If you have developed cancer after ingestion of the recalled drugs, valsartan—losartan and/or irbesartan, contact us for a free consultation at 1-800-814-4540 or email carolyn@carolynstclair.com. Do not stop taking your drugs without consulting your doctor and getting approval. Time limits apply so contact us now before your time runs out.

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