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Despite a flurry of initial concerns, the findings of a new study suggest the side effects of valsartan, irbesartan and similar hypertension drugs do not appear to have any effect on the outcomes or severity of COVID-19 infections.
Brazilian researchers indicate that taking angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (AEIs) does not appear to affect survival rates for the novel coronavirus, which has killed about 400,000 people in the U.S. alone over the last year. Their findings were published on January 19 in the Journal of the American Medical Association (JAMA).
The drugs are usually used to treat high blood pressure, and include brand name drugs such as Avapro (irbesartan), Cozaar (losartan), Benicar (olmesartan) and Diovan (valsartan).
Some preliminary research from last year warned that taking the blood pressure medications appeared to cause worse outcomes for those diagnosed with COVID-19 infections, and were more likely to face complications than those not taking the hypertension drugs. This latest study appears to question those findings.
This study sought to determine whether discontinuing the drugs once diagnosed with COVID-19 or whether continuing to use them resulted in worse outcomes. They conducted a randomized clinical trial involving 659 patients hospitalized in Brazil with mild to moderate symptoms of COVID-19 who were taking the drugs before they were hospitalized. The researchers had 334 patients discontinue use, and 325 patients who continued using the drug once diagnosed.
Researchers report the differences were statistically insignificant when comparing mean number of days alive and out of the hospital following the diagnosis. According to the findings, the mean number of days alive and out of the hospital was 21.9 days for those who discontinued the drugs, and 22.9 days for those who continued taking them.
In addition, there was no statistically significant difference in death rates, cardiovascular death or COVID-19 progression, heart failure or acute kidney failure.
“Among patients hospitalized with mild to moderate COVID-19 and who were taking ACEIs or ARBs before hospital admission, there was no significant difference in the mean number of days alive and out of the hospital for those assigned to discontinue vs continue these medications,” the researchers concluded. “These findings do not support routinely discontinuing ACEIs or ARBs among patients hospitalized with mild to moderate COVID-19 if there is an indication for treatment.”
COVID-19 Blood Pressure Drug Concerns
Throughout the pandemic, researchers have struggled to determine the roll of blood pressure medications on COVID-19 patients. At first, there were concerns the medications increased the dangers of the virus. However, the findings of a study published in May indicated patients who take ACE inhibitors or ARBs are not more likely to suffer worse symptoms from COVID-19.
Furthermore, a second study published in July concurred with these findings, indicating patients who take blood pressure medications do not face more severe illness from COVID-19 or have an increased risk of death. These findings contradict the conclusions of the newest trio of studies.
Three studies, presented at a medical conference in September, but not published for peer review at that time, warned that more patients taking the medications died of COVID-19, compared to those not taking the drugs. Some have said the risks may have been tied to having high blood pressure in the first place, or other contributing factors, such as diabetes.
Valsartan NDMA Lawsuits
In addition to COVID-19 concerns, some of the drugs, particularly valsartan are the subject of several hundred product liability lawsuits filed throughout the federal court system, each involving similar allegations that former users of valsartan or other sartan-based medications were diagnosed with cancer due to exposure to N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and other chemical byproducts that resulted from changes to the generic drug manufacturing process.
The chemicals are known human carcinogens, which have been discovered in nearly all versions of the generic drug distributed prior to massive valsartan recalls issued in July 2018.
Lawsuits allege that long-term exposure to recalled valsartan pills have been linked to reports of stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer and other injuries which developed as the chemicals traveled through the digestive system.