According to a CBS News report from Oct. 10, the Public Interest Research Group (PIRG) believes the U.S. Food and Drug Administration (FDA) is not evaluating valsartan impurities and potential contamination in other hypertensive drugs in an efficient and speedy manner.

Since March 2019, the drug oversight agency has been reviewing high-blood pressure medications in the same drug family. The goal was to complete the review of valsartan impurities and taints with other drugs in this group within a six-month window.

To date, slightly over one-quarter of said medications have undergone evaluation. To accommodate this six-month window, the FDA had to increase allowable levels of a chemical found to be in excess in certain batches of pills.

According to a blog post issued by Harvard Health Publishing on Aug. 5, 2019, the issue of valsartan impurities and other potential pharmaceutical contamination first hit FDA radar in 2018. A supplier of active pharmaceutical ingredients (API’s) used to manufacture certain types of hypertensive medications contacted the FDA to alert them to the presence of nitrosamine excess in said ingredients used to produce valsartan.

What are the Contaminants?

Further investigation by the FDA upturned contamination sourced by ingredient suppliers at two factories located in both China and India. According to WebMD.com on Sept. 23, 2019, there are three chemicals that have been of concern, leading to subsequent recalls of drugs in the sartan family–N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-Nitroso N-Methyl 4-amino butyric acid (NMBA).

CBS News indicates that nitrosamines are common and found in natural sources such as vegetables and water. They are also present at a slightly higher level but within the body’s ability to process in cured meats such as salami, bacon, and ham. The trouble is that they are believed to be probable human carcinogens and exposure must be limited to prevent health problems.

At this point in the review process, PIRG has noted that 61 percent of the medications examined by the FDA have revealed amounts of the contaminants that exceed the increased allowable amount put into force by the agency during the testing period. Nevertheless, pulling excessive amounts of medication from the commercial marketplace that is vital and lifesaving to those with hypertensive disorders can present a greater health crisis than the contaminant itself.

The FDA has purportedly calculated that only one additional case of cancer would likely show up if 8,000 hypertensive patients were taking high-blood pressure drugs with the highest level of contaminants daily over four years. Statistically speaking, this threat is low compared to many people suffering from cardiac arrest due to soaring blood pressure and a shortage of pharmaceutical supply because of valsartan recalls.

According to CBS News, PIRG indicates that the FDA has initiated the recall of 14 blood pressure meds since March of this year alone. If a patient is on valsartan or any blood pressure remedy they are concerned about, they should contact their pharmacist to verify its status.  No medication regimen should be discontinued without evaluation and discussion with the prescribing physician as well.