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Update on Blood Pressure Medication Recalls

UNITED STATES – As reported in an online news article published by www.abc10.com, many questions remain as to how serious the cancer risk is for patients who have continued taking their blood pressure medication subject to recall. One year after the United States Food and Drug Administration (FDA) issued its first recall notification of certain […]

Blood Pressure Medication Recalls Linked to Cancer Risk

Blood pressure medication recalls

UNITED STATES – As reported in an online news article published by www.abc10.com, many questions remain as to how serious the cancer risk is for patients who have continued taking their blood pressure medication subject to recall.

One year after the United States Food and Drug Administration (FDA) issued its first recall notification of certain popular and widely used blood pressure medications, questions remain as to the severity of the cancer risk as well as whether there will be additional recalls going forward.  The specific blood pressure medications subject to recall are various generic versions of Valsartan, Losartan, and Irbesartan, all of which are part of the class of drugs called Angiotensin II Receptor Blockers (ARB). The affected drugs treat patients with high blood pressure and heart failure.

The FDA has issued a total of 53 recall notifications pertaining to blood pressure medications that have been contaminated with various substances linked to cancer, with the first recall notification being released in July of 2018.  The various cancer-causing substances found in many ARBs include the following nitrosamines:

  • N-Nitrosodimethylamine (NDMA);
  • N-Nitrosodiethylamine (NDEA); and
  • N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).

According to the FDA, NDMA and NDEA are known probablehuman carcinogens, while NMBA is a known potentialhuman carcinogen.  The FDA also states that nitrosamines can be found in water, meats, dairy products, and vegetables.

The nitrosamine impurities were likely present in the manufacturing process, possibly generated from certain chemical reactions when manufacturing the key ingredient to the blood pressure medications.  Additionally, cancer-causing impurities may be present in the blood pressure medications because of reusing materials, such as solvents.

Doctors Say It’s Dangerous in the Short-Term to Stop Taking the Affected Blood Pressure Drugs

The FDA indicates that the risk of cancer associated with exposure to contaminated blood pressure medication is low and that cancer will not develop overnight.  Moreover, doctors state that it is more dangerous for patients in the short-term to stop taking their blood medications, as this could exacerbate underlying conditions, such as high blood pressure and heart failure, and potentially heart attack or stroke.  Patients are instructed to speak with their doctors about the risks of stopping their blood pressure medication and whether there are alternative medications available to treat the underlying condition heart condition(s) adequately.


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