The US Food and Drug Administration announced on Monday, August 20, that the widespread recall of valsartan-containing high blood pressure blood pressure agents related to carcinogenic risk was again expanding.
In the latest update, the FDA says in a news report that it has recently learned that NDMA has been detected in some Torrent Pharmaceuticals Limited drugs containing valsartan. As with the latest expansion, not all Torrent products containing valsartan are recalled in the US.
The original recall for valsartan-containing medicines was announced a month ago on 13 July after tests showed that some products may have been contaminated with the carcinogen.
NDMA is classified as a probable carcinogen for humans – a substance related to cancer – by an international cancer research agency. It is described as a "known environmental pollutant" and NDMA is found in water in foods including meat, dairy and plant products, according to the FDA.
The substance was found in "multiple batches of Valsartan tablets" manufactured by Hetero Labs Limited and Zhejiang Huahai Pharmaceuticals.
Click here to view the complete list of affected valsartan-containing products. Click here to view an updated list of those who have not been affected by the recall.
"FDA reminds patients taking valsartan to a recalled party that they should continue to take their current medicine until their doctor or pharmacist provides a replacement or other treatment option," said the administration in her latest update.
"Not all valsartan products contain NDMA, so pharmacists may be able to provide a valsartan medication supplement that is not affected by the recall, or doctors may prescribe another medication that treats the same condition."
WIRE: #FDA continues its research into the cause of the impurity that led to the recall of valsartan-containing products to ensure that all products involved are known and the problem is resolved. https://t.co/mDKNfV9wPw We have a major operation in progress.
– Scott Gottlieb, M.D. (@SGottliebFDA) August 20, 2018
CNN reports that scientists with the FDA estimate that if 8,000 took 320 milligrams of affected valsartan-containing products every day for four years, adding cancer could cause cancer.
Anyone prescribing or currently using valsartan-containing products is asked to contact their doctor for "further guidance and possible treatment change before they stop using this product". The FDA advises consumers to call 1-800-505-9291 or e-mail [email protected] with questions or comments.