Valsartan medication, a common blood pressure drug available as a generic, is under scrutiny for allegedly containing a chemical classified as a probable human carcinogen by the World Health Organization (WHO) and the American Cancer Society (ACS).

According to Fortune Magazine, the U.S. Food and Drug Administration (FDA) was notified by an online pharmacy that operates in 37 U.S. states that it noted high levels of dimethylformamide (DMF) in valsartan medication. The generic blood pressure drug is made by several pharmaceutical companies, and its active ingredient is also added to other ingredients to be marketed as combination drugs.

In a separate CBS News article concerning this alert on June 18, 2019, Valisure, the online pharmacy that revealed the DMF levels, asked the FDA to lower acceptable levels of the chemical solvent. It also asked to recall the valsartan medication maintaining these high amounts.

The FDA has responded to this request by initiating a review. It encourages patients already taking valsartan to continue taking it until they can consult their physician about switching to another medication. Sometimes the removal of a drug vital to health maintenance of a condition can be more damaging than any solvent elevation.

Not the First Time

This is not the first time in recent history that this generic medication has been found to be tainted. In July 2018, according to Bloomberg, several varieties of generic valsartan were recalled when N-Nitrosodimethylamine (NDMA) was discovered in versions made by a company out of China. NDMA is also a noted carcinogenic chemical.

Efforts to recall NDMA tainted drugs by the FDA led them to encourage patient consumers to consult with their pharmacists about versions of the drug known to be safe. This recent DMF-level taint was discovered in alternative versions thought to be okay, making the recall more complicated and elusive.

As indicated in the Bloomberg article, several other valsartan manufacturers, such as including Switzerland’s Novartis, claim they and related companies that make ingredients for them do not use the solvent. The problem may lie in a lack of transparency in a supply chain that extends back further.

The FDA’s investigation will examine how the heart medication became contaminated. It has been postulated that perhaps the use of DMF in the process of manufacturing can lead to chemical reactions which create other potential carcinogens.

Pills are often combined from raw materials which may made need be broken down into other forms before going into the mix. A solvent such as DMF is an inexpensive element to do just this and was classified as carcinogenic last year. For the most part, solvents tend to disappear from the mix by the time the drug reaches the pharmacist’s shelves, as indicated in the Bloomberg article.

Because of this need to break down raw materials, the FDA has a set standard of how much DMF is allowable in terms of daily human intake. This scale was revised two years ago. To date, the regulatory agency claims that 8.8 nanograms is an acceptable daily intake level.