Blood Pressure Medication Recall: the FDA

There are a number of high blood pressure medications which are involved in voluntary recalls, due to various carcinogens contained in the drugs. These blood pressure medication recalls cover many different drugs, many different manufacturers, and several different carcinogens. In June of this year, an online pharmacy filed a petition with the FDA saying they found yet another cancer-causing chemical in one of the recalled blood pressure medications. So far there have been valsartan recalls, losartan recalls, amlodipine recalls, irbesartan recalls and hydrochlorothiazide recalls.

Teva Pharmaceuticals and Aurobindo Pharma USA are just two of the many manufacturers under fire. At present it appears that the brand name valsartan and other drugs are not being recalled as no carcinogens have been found in them—it is only the generics, and not all of those. There is a comprehensive list of high blood pressure medication recalls on the FDA website:  https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and.

The latest recall involved DMF found in valsartan—a known carcinogen. Earlier, NMBA, NDEA and NDMA, also known carcinogens, were found in different high blood pressure medications. NMBA is N-Nitroso N-Methyl 4-amino butyric acid, which is classified as a potential cancer-causing substance. NDEA and NDMA are N-nitrosodiethylamine, which is classified as a probable carcinogen. In early February, the Japanese subsidiary of Pfizer, Inc. announced it was recalling a drug for high blood pressure because of the NDEA found in the active ingredient, valsartan. In early August, FDA officials announced they had updated the list of drugs affected by the recall which was originally announced in July. The FDA also noted that the recall is now worldwide.

FDA Says Presence of NDMA was Unexpected - The FDA noted that the presence of NDMA was unexpected and is believed to be related to changes in the way the active ingredient was manufactured. The affected drugs are all generic versions of the brand name Diovan, made by Novartis International AG. Diovan and the generic versions made by other companies are not included in the current recall. The drug valsartan is not the actual problem, rather it is the contaminant which was included in the manufacturing process.

The FDA is working with the affected companies to reduce or eliminate the valsartan impurity from future products. According to the EPA, NDMA forms during both industrial and natural processes and was formerly used in the production of lubricant additives, the production of liquid rocket fuel, fish processing, and the making of rubber tires. Exposure to high levels of NDMA can cause liver damage.

Issues Regarding DMF and NMBA - DMF is a chemical which is easily absorbed through the skin and is known to cause liver damage and other adverse health effects. DMF is a solvent used in chemical manufacturing, paint stripping solvents, printing, and adhesive formulations. In addition to being toxic to the liver, some studies have linked DMF to various forms of cancer. DMF can also cause skin problems, heart palpitations, chronic headache, flushing of the face and trunk, nausea and vomiting. Some reports seem to establish that DMF alters the genetic materials in cells.  

NMBA is the third type of nitrosamine impurity detected in high blood pressure medications which are currently under recall. NMBA levels in losartan potassium tablets show higher NMBA levels than the FDA deems acceptable. The evaluation of the FDA suggests a chemical reaction which occurs during the manufacturing process of the drug. It is also possible that the NMBA levels are the result of the reuse of materials, such as solvents.   

Nitrosamine Impurities Continue to Be Found in Blood Pressure Medications - The FDA notes it is “deeply concerned” regarding the presence of a third nitrosamine impurity in the blood pressure medications, however the agency underscores the fact that the increased frisk of cancer to patients with NMBA exposure appears to be the same as for NDMA exposure, but less than the risk from NDEA exposure. That being said, the agency also stated, any level of these impurities in prescription drugs is unacceptable.

The FDA has conducted an extensive investigation, working with the drug companies to address the presence of the impurities in the high blood pressure medications. FDA scientists have developed highly sophisticated testing methods which detect and measure NDMA and NDEA in these medications. Because of the potential for discovering other nitrosamine impurities, the FDA is now conducting an analysis which will help them develop testing methods to detect NMBA. These methods are being shared with the drug manufacturers in order to prevent the formation of the impurities during the drug manufacturing process.  

FDA Continues Testing for Impurities - The FDA continues its investigation; After NDMA and NDEA were found in drugs which contained the active pharmaceutical ingredients valsartan, losartan and irbesartan were recalled, NMBA was found in lots of losartan potassium during recent testing. While the FDA did find that the risk to individual patients is fairly low, they recommended caution, saying the issue is significant and they are concerned. Continued testing on these blood pressure drugs for NDEA, NDMA, NMBA and other nitrosamine impurities will continue as the FDA works with the manufacturers to remove affected products from the market as quickly as possible.

FDA will Continue Updating High Blood Pressure Medication Recall List - The FDA will also continue to update the list of affected medications and recalls, as ongoing testing will make this information available. The FDA wants patients taking these blood pressure medications—even those that have been recalled—to continue taking their medication until they can talk to their physician and have an alternative drug prescribed. The blood pressure medication recall is serious and should be taken seriously. Teva Pharmaceuticals and Aurobindo Pharma USA are the most recent manufacturers involved in the high blood pressure medicine recall. This blood pressure medication recall FDA is ongoing, and patients are advised to watch for further information on the valsartan recall, losartan recall, amlodipine recall, irbesartan recall and hydrochlorothiazide recall.

How a Sullo & Sullo High Blood Pressure Medication Recall Attorney Can Help - It can be extremely beneficial to have a Sullo & Sullo personal injury lawyer by your side during this difficult time. You may be eligible for a valsartan cancer lawsuit, a losartan cancer lawsuit, an irbesartan lawsuit, an amlodipine lawsuit or a hydrochlorothiazide lawsuit. We can answer all your questions regarding the recalls, a potential high blood pressure medication lawsuit, and whether irbesartan class actions will occur. If you have suffered injury after taking a blood pressure medication with potentially carcinogens, contact Sullo & Sullo today.

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