In June, the U.S. Food and Drug Administration (FDA) issued a voluntary recall of some drug medications containing valsartan, an ingredient used to treat high blood pressure.
Not all products containing valsartan were affected. The FDA only recalled products containing a chemical impurity known as N-nitrosodimethylamine (NDMA) and classifies NDMA as a human carcinogen. Typically, NDMA is not a product in these drugs, which is also why the FDA has raised concern over certain products. The FDA recommends that people using valsartan-based medications continue taking the medication until users can find an alternative product. The FDA has released a list of companies that have distributed valsartan products containing the impurity:
- Major Pharmaceuticals
- Solco Healthcare
- Teva Pharmaceuticals Industries Ltd.
These companies get their supply of valsartan as an active ingredient from a third party, and the FDA is working with these companies to “reduce or eliminate the valsartan impurity from future products.”
The FDA’s recall comes on the heels of recalls in other countries such as Canada, Germany, and other European nations with concerns over the same impurity. However, the FDA said in a statement that “the [FDA] does not comment on third-party announcements but evaluates them as a part of a body of evidence to further our understanding of a particular issue,” regarding holding their announcement until the following week.
The issue in Europe is linked to Zhejiang Huahai Pharmaceuticals, a supplier of valsartan. In the U.S., it is unclear if there is a connection between the presence of NDMA and Zhejiang Huahai Pharmaceuticals. The FDA has said that it is continuing its research and investigation as to whether or not the NDMA presence has made any impacts on valsartan users, how widespread that impact may be, and if the U.S. contamination can be traced back to any particular supplier.
A spokesman for Novartis, a pharmaceutical company, based out of Switzerland, claimed in an email reported by CNN that “There is no certainty as to how much this contaminant may potentially increase cancer risk in humans. Thus, the amount of NDMA found in the Valsartan [supply] would not represent a significantly increased risk to patients.”
However, NDMA is present in rocket fuel, lubricants, and is an unintentional byproduct of rubber tires. According to an Environmental Protection Agency fact sheet on NDMA, the Department of Health and Human Services conducted a study with various NDMA exposures on experimental animals which resulted in tumors in the liver and kidneys. However, harm to humans would require higher exposure to the substance.
Exposure to NDMA can lead to headaches, fever, nausea, vomiting, and reduced function in the kidneys, liver, and lungs.
The FDA recommends that those taking drugs for high blood pressure or medicines that may contain valsartan should identify which company the medication originated from on their prescription, and contact their doctor for alternative treatments. Patients using a recalled drug should also call the respective drug company or go on their website for instructions about the recall.
It is important to note that not all valsartan drugs are being recalled. Valsartan is considered safe, where the accidental presence of NDMA is not.