While recalls of blood pressure medications over carcinogen concerns dominated health news headlines last year, it appears that the trend has not quite ceased in 2019.
Aurobindo Pharma USA, Inc., recently announced it was voluntarily recalling 80 lots of its valsartan tablets after detecting trace amounts of a possibly cancerous impurity. For now, this only seems to be a precautionary measure as the exact long-term risk of developing cancer is not known.
There have not been any reports of people suffering adverse effects as a result of taking the recalled medication, the company stated in a press release posted on the Food and Drug Administration website.
The impurity involves a chemical called N-nitrosodiethylamine or NDEA, which is a gasoline and lubricant additive in addition to having other industrial uses. It is “considered to be reasonably anticipated to be a human carcinogen,” according to the National Institutes of Health.
Patients who take blood pressure medication should take a look at the complete list of the recalled products compiled by the FDA website. Do check the product name, the manufacturer details, and the batch or lot number printed on the bottle. The expiration dates fall within the May 2019 to March 2021 range.
If your medication has been affected by the recall, contact a health care professional for further information. Experts note it is very important that you do not stop taking the medication until you are provided with a suitable substitute.
“Patients taking the recalled valsartan-containing medicines should consult their doctor or pharmacist and continue taking their medicine until they have a replacement product,” Dr. Suzanne Steinbaum of Mount Sinai in New York told CNN after a similar recall last year.
Alternative treatment options, as advised by an expert, may involve opting for a different manufacturer or switching to another blood pressure drug. While the best option varies for every individual, all patients are at risk of experiencing a sudden spike in blood pressure.
“The conditions the medication treat — heart failure and high blood pressure — are serious, and patients could be harmed if they suddenly stop taking it without a replacement prescription,” Dr. Steinbaum added.
Traces of carcinogens also led to the recall of valsartan combination tablets by Teva Pharmaceuticals in December. Several medicines containing valsartan were voluntarily recalled by several drug companies since July 2018.
Given the high frequency of recalls, many experts have called for improving control of manufacturing processes as the affected drugs were traced back to factories in China and India.
Due to factors like poor training, it is possible that “impurities introduced through chemical reactions and so forth,” explained Robert Handfield, director of the Supply Chain Resource Cooperative at North Carolina State University.