The U.S. Food and Drug Administration on Friday downplayed the risk caused by co...
NEW YORK - The U.S. Food and Drug Administration on Friday downplayed the risk caused by contamination of the already recalled popular heartburn drug Zantac, and said its tests suggest it does not cause carcinogens to form after ingestion by patients.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that the levels of the probable carcinogen N-nitrosodimethylamine it found in ranitidine - sold under the brand name Zantac - “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.
Zantac, sold in the United States by French drugmaker Sanofi SA, and some generic versions of the treatment have been recalled due to possible NDMA contamination. The FDA had said in October it found unacceptable levels of NDMA in drugs containing ranitidine. Valisure Chief Executive David Light in a statement criticized FDA testing methods as “overly simplistic conditions that do not properly evaluate a real-world stomach” and urged the agency to completely recall ranitidine and a similar drug, nizatidine.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA testing indicates Zantac does not form carcinogen in usersThe results come from lab tests, but the agency said that it still plans to test the drug in human patients.
Read more »
Zantac does not form impurity in users, FDA saysAs part of its investigation into an impurity found in heartburn medication Zantac OTC, the US Food and Drug Administration has found levels of the impurity 'similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.'
Read more »
FDA issues Halloween warning: Decorative contact lenses can cause blindness, infection, cornea scratches'Wouldn't it be cool to have vampire eyes for Halloween? Or deep violet eyes to match your purple sweater? How about your favorite sports team's logo on your eyes just for fun?' the FDA warning begins.
Read more »
Trump bets on Washington outsider to lead FDA amid political battles
Read more »
FDA panel recommends withdrawing approval of Makena drug, used to prevent preterm birthsA committee for the US Food and Drug Administration now recommends that the approval of Makena, a drug used to reduce the risk of preterm births, should be withdrawn — and some women who have used the medication are sounding the alarm
Read more »
Trump to pick Texas cancer doctor to head FDA
Read more »