Blood Pressure Medication Recall: Questions

What Drugs are Part of the High Blood Pressure Medication Recall? You may have heard about the most recent high blood pressure medication recalls; over the past year there have been a number of the high blood pressure medication recalls taking place.  These high blood pressure/heart medications include the generics valsartan, losartan, irbesartan, amlodipine and hydrochlorothiazide, which have been found to have NDMA, NDEA, NMBA and DMF. All the tainted medications were manufactured in China and India. The list of recalled high blood pressure medications is extremely long; you will need to check your particular medication’s lot number against the recalled medications.

High blood pressure medications which had been recalled as of last October included those sold by Teva Pharmaceuticals labeled as Major Pharmaceuticals, Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC, Teva Pharmaceuticals USA labeled as Actavis, AvKARE (Teva/Actavis), RemedyRepack Inc. (Prinston/Solco), A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco), Bryant Ranch Prepack Inc. (Teva/Actavis), H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco), Northwind Pharmaceuticals (Teva/Actavis), Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc., NuCare Pharmaceuticals Inc. (Prinston/Solco), RemedyRepack, Inc. (Hetero/Camber), AvKARE (Hetero/Camber), Preferred Pharmaceuticals, Inc. (Hetero/Camber), Torrent Pharmaceuticals Limited, and RemedyRepack, Inc. (Torrent). Since that time there have been many more high blood pressure medication recalls. Additional information about the specific recalled products, including doses, lot numbers and expiration dates, is detailed on the FDA's website, which can be accessed at this site: https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and


Who Manufacturers These Drugs? The most recent manufacturers involved in the high blood pressure medication recall are Teva Pharmaceuticals and Aurobindo Pharma USA. Torrent Pharmaceuticals Limited, AvKare, Torrent, Actavis, Camber Pharmaceuticals, Hetero Labs, Inc., Heritage Pharmaceuticals, Legacy Pharmaceutical Packaging, Macleod’s Pharmaceutical Limited, Mylan Pharmaceuticals, NuCare Pharmaceuticals, Prinston Pharmaceuticals, Solco Healthcare, Rising Pharmaceuticals, ScieGen Pharmaceuticals, GSMS Incorporated and Actavis Pharma, Inc. have all been involved in the high blood pressure medication recall as well. Teva Pharmaceuticals, like Aurobindo Pharma USA and other major manufacturers have many subsidiaries. 

Why Were the Drugs Recalled? The blood pressure/heart medications involved in the recall have all been found to be contaminated with NDMA, NDEA, NMBA or DMF. These are all chemicals which are believed to be known carcinogens which can potentially cause cancer or liver problems in humans. According to the records from drug manufacturers, it is believed the toxic substances could have been in the valsartan, losartan, irbesartan, amlodipine and hydrochlorothiazide for as long as four years. The common thread among the medications in the high blood pressure medication recall is that all the drugs or drug ingredients were made in India or China. Many American drug companies use overseas factories to manufacture medications for the United States—as many as 40 percent of all finished medications are manufactured in another country, and 80 percent of active pharmaceutical ingredients made into medications at other plants are manufactured overseas. The FDA is actively investigating how the drugs could have possibly been contaminated. The inspectors for the agency currently believe the contaminated compounds were created through a chemical reaction, however the investigation is ongoing.

What is Nitrosodiethylamine (NDEA) and is it Dangerous? NDEA is used in the manufacturing of rocket fuel and is also created by chemical reactions as a byproduct of industrial processes, including the manufacture of pesticides, the manufacture of rubber tires, and fish processing. While the FDA considers the risk of being diagnosed with cancer due to the small amounts of NDEA, NDMA, NMBA and DMF found in the recalled blood pressure drugs is small, the amounts nonetheless exceed FDA’s acceptable levels. NMBA was the third nitrosamine impurity found in blood pressure medications; the increased risk of cancer to patients with NMBA exposure, according to the FDA, appears to be the same as for NDMA exposure, but less than the risk from NDEA exposure.

DMF is considered a potent liver toxin which can cause abdominal pain, nausea, vomiting, headaches, weakness, skin issues, dizziness and alcohol intolerance. The possible adverse reproductive effects of DMF in humans has not been adequately studied, however there are indications that DMF can have such effects. The FDA has developed sophisticated testing methods to detect and measure NDMA and NDEA impurities in medications and are working on the same type of testing to measure NMBA and DMF.

Are There Currently any Lawsuits Involving the Drugs in the High Blood Pressure Medication Recall? There are currently lawsuits filed involving the impurities in the high blood pressure medication recall. Lawyers involved in these lawsuits believe there will be over 2000 additional high blood pressure medication recall lawsuits filed over the next two years, including: valsartan cancer lawsuit, losartan cancer lawsuit, irbesartan cancer lawsuit, hydrochlorothiazide cancer lawsuit and amlodipine cancer lawsuit. If you believe you have an amlodipine recall lawsuit, a hydrochlorothiazide recall lawsuit, an irbesartan recall lawsuit, a valsartan recall lawsuit or a losartan recall lawsuit, it is important that you seek legal assistance from an experienced personal injury lawyer.

As just one example. Barbara Kruk filed an irbesartan lawsuit in the U.S. District Court for the Middle District of Florida, seeking class action status against Aurobindo Pharma, Sciegen Pharmaceuticals, Westminster Pharmaceuticals and Walmart. According to this irbesartan lawsuit, the medication taken by Kruk was contaminated with a known human carcinogen—NDEA. Those who have taken these tainted medications must now undergo lifelong medical monitoring due to the increased risk of cancer and liver problems.

Do I Have a Valsartan Cancer Claim? You may wonder whether you have a valsartan cancer claim. The only way to answer this question for certain, is to speak to a knowledgeable valsartan attorney. Your valsartan lawsuit lawyers will thoroughly evaluate your medical issues and the medications you were taking to help you determine whether a valsartan cancer lawsuit is appropriate in your situation. In July 2018, the FDA issued the largest ever class 1 recall of certain valsartan drugs due to contamination with NDMA. If you have taken valsartan, you may be entitled to file a valsartan recall lawsuit or could potentially take part in a valsartan class action lawsuit. It is important that you speak to valsartan lawsuit lawyers to determine whether you have a valid valsartan cancer claim 

Do I Have a Losartan Cancer Claim? You may have a losartan cancer claim if you have taken losartan medications which were found to be tainted with a carcinogenic substance. Whether you have yet developed symptoms, you may be entitled to file a losartan recall lawsuit, or possibly take part in a losartan class action. In April of this year there was a mass voluntary losartan recall—104 lots managed by Torrent Pharmaceuticals Limited, made in an India facility. At that time, Camber Pharmaceuticals, Inc., had already issued a recall of certain lots of losartan, valsartan and irbesartan. The United Arab Emirates was attempting to withdraw losartan from the market entirely due to the presence of NDEA in the drug, and dozens of losartan lawsuits have already been filed against drug makers and sellers. It is important that you speak to losartan lawsuit lawyers to determine whether you have a losartan cancer claim.  

Do I Have an Irbesartan Cancer Claim? You may have an irbesartan cancer claim if you have taken the drug in the past, and the specific irbesartan lot you have taken is a part of the high blood pressure medication recall. Irbesartan, like valsartan and losartan, are angiotensin II receptor blockers used to treat high blood pressure. NDEA has been found in some lots of irbesartan (full list on the FDA website). NDEA is used as an additive in lubricants and has been used in experimental research to induce liver tumorigenesis. NDEA is classified as a probable human carcinogen by the International Agency for Research on Cancer. ScieGen Pharmaceuticals issued a voluntary nationwide recall of irbesartan tablets due to the potential cancer risk related to the NDEA impurities. You may have an irbesartan cancer lawsuit or, potentially an irbesartan class action lawsuit. It is important that you speak to a qualified irbesartan attorney to determine whether you have an irbesartan cancer claim.

Do I Have a Hydrochlorothiazide Cancer Claim? Hydrochlorothiazide is sometimes used in conjunction with the medications valsartan, losartan an irbesartan as a diuretic. Because of this, some of those patients taking one of the medications involved in the high blood pressure medication recall may have ingested tainted hydrochlorothiazide, whether the medication was tainted with NDMA, NDEA, NMBA or DMF. If you have taken hydrochlorothiazide, you may have a hydrochlorothiazide cancer claim. It could be beneficial to speak to a hydrochlorothiazide lawyer who can help you determine whether you should file a hydrochlorothiazide lawsuit.    

Do I Have an Amlodipine Cancer Claim? Amlodipine is sometimes used in combination with valsartan, losartan or irbesartan, therefore could be involved in the high blood pressure medication recall. The amlodipine contained in some of these recalled drugs could potentially be tainted by impurities. If you have taken amlodipine, it could be beneficial for you to speak to a knowledgeable amlodipine attorney, regarding a potential amlodipine cancer lawsuit.

Getting the Help You Need for Your High Blood Pressure Medication Recall Lawsuit - If you have taken one of the recalled high blood pressure/heart medications listed on the FDA website, it could be helpful for you to speak to an experienced Sullo & Sullo valsartan lawyer. We are deeply involved in this issue and want to help those harmed by the impurities in these drugs which can potentially cause cancer, liver problems, or other issues. If you believe you are entitled to file a valsartan recall lawsuit, contact an experienced Sullo & Sullo losartan attorney today who can help you determine whether an irbesartan recall lawsuit is right for you.

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