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. Source
HOME NEWS & ANALYSIS NEWS IN BRIEF Medicines MHRA issues further recall for irbesartan The Pharmaceutical Journal28 JAN 2019 The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled more irbesartan-containing blood pressure and heart medication from UK pharmacies as it continues to investigate possible contamination of sartan products. The recall, announced 24 January 2019, has been described by the regulatory body as a precautionary measure after testing revealed possible N-nitrosodiethylamine (NDEA) contamination. The MHRA said there was “no evidence at present that the impurity has caused any harm to patients and not all irbesartan products are affected”. This latest recall affects three batches of irbesartan 150mg and 300mg tablets, which is supplied by Macleods Pharma UK. Because of the risk associated with suddenly stopping medication for high blood pressure, patients are advised to continue to take their medicines and to speak to a doctor or pharmacist if they have any concerns, the agency said. Earlier in January 2019, the MHRA advised pharmacies to recall all affected batches of irbesartan-containing medicines made by Actavis. Valsartan-containing medicines supplied by Dexcel and Actavis (now Accord) were recalled in July 2018followed by a further recall of batches of valsartan-containing medicines supplied by Mylan and Teva in November 2018, owing to concerns over NDEA and N-nitrosodimethylamine contamination. The MHRA said it is continuing to investigate the contamination issue alongside the European Medicines Agency and the European Directorate for the Quality of Medicines. Sam Atkinson, director of the inspection, enforcement and standards division at the MHRA, said: “We continue to investigate [the] potential contamination of sartan-containing medicines, such as irbesartan. We will continue to act and provide updates when appropriate.”
