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KANSAS CITY, Mo. – The US Food and Drug Administration said it found an additional "unexpected impurity" in three lots of valsartan-based medicines recalled by Torrent Pharmaceuticals.
Several pills containing valsartan, a generic ingredient that helps people with hypertension and heart failure, have been the subject of a voluntary recall since July. The drugs were contaminated with N-nitrosodimethylamine, or NDMA, an impurity considered a possible carcinogen by the US Environmental Protection Agency. It is an organic chemical used to make liquid fuel for rockets and a by-product of the manufacture of certain pesticides and fish processing. NDMA can be unintentionally introduced into the manufacture by certain chemical reactions.
Not all versions of the drugs have been recalled, but the FDA keeps a regularly updated list of medications that have been affected.
On Thursday, the FDA said three batches of drugs manufactured by Torrent Pharmaceuticals were contaminated with a second impurity, N-nitrosodiethylamine or NDEA, which is also a suspected carcinogen to humans. The agency began testing the recalled products and pills that were not recalled for the substance after learning that Zhejiang Huahai Pharmaceuticals had found NDEA in several batches of its active ingredient valsartan. All lots are not contaminated.
In response to the second identified impurity, Health Canada also issued guidelines on what patients taking valsartan medications should do.
What to do if you are taking valsartan
If you are concerned that your medicine is on the recall list, consult your doctor or pharmacist before changing your medication regimen. Since all valsartan medications are not involved in the recall, they may be able to offer you a version of the drug manufactured by another company.
If you know your medicine is on the recall list, the FDA suggests that you continue to take it until your doctor or pharmacist provides you with one.
The FDA has indicated that it will continue testing all products containing valsartan to detect NDEA impurities as well as NDMA. The tests should be completed in the next few days.
"As we continue to study the root cause of impurities in products containing valsartan, our scientists are testing these products to better understand these impurities and ensure they are not present in other products. We are also taking steps to ensure that we strictly monitor manufacturing processes to reduce the likelihood of impurities being introduced into other products, "said FDA Commissioner Dr. Scott Gottlieb. "As we expand our investigative efforts, we will continue to ensure that the public has the latest information. We will also continue to work with global regulatory agencies to learn as much as possible about how these impurities have emerged and how they can affect the health of patients around the world. "
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