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ranitidine: FDA finds low levels of cancer-linked impurity (NDMA) in common heartburn drugs
Source: CNN
FDA finds low levels of cancer-linked impurity in common heartburn drugs
By Jacqueline Howard and Jamie Gumbrecht, CNN
Updated 2121 GMT (0521 HKT) September 13, 2019
(CNN) — The US Food and Drug Administration said on Friday that it has learned that some ranitidine -- acid-reducing and heartburn medicines, including those known by the brand name Zantac -- contain low levels of an impurity that could cause cancer.
The nitrosamine impurity known as N-nitrosodimethylamine or NDMA has been classified as a probable human carcinogen based on lab tests, and this isn't the first time that it has been detected in a common medication.
Since last year, the FDA has been investigating NDMA and other impurities in blood pressure and heart failure medicines known as angiotensin receptor blockers or ARBs. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in several of those common drugs containing valsartan.
A study published last year in the medical journal BMJ found no "markedly increased short term overall risk of cancer" among users of the valsartan drugs contaminated with NDMA. Yet that study also noted that research into long-term cancer risk is needed.
Now, with NDMA being found in samples of ranitidine, "we are still investigating all ranitidine products and we are continuing to test additional samples," FDA spokesman Jeremy Kahn said in an email on Friday.
-snip-
By Jacqueline Howard and Jamie Gumbrecht, CNN
Updated 2121 GMT (0521 HKT) September 13, 2019
(CNN) — The US Food and Drug Administration said on Friday that it has learned that some ranitidine -- acid-reducing and heartburn medicines, including those known by the brand name Zantac -- contain low levels of an impurity that could cause cancer.
The nitrosamine impurity known as N-nitrosodimethylamine or NDMA has been classified as a probable human carcinogen based on lab tests, and this isn't the first time that it has been detected in a common medication.
Since last year, the FDA has been investigating NDMA and other impurities in blood pressure and heart failure medicines known as angiotensin receptor blockers or ARBs. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in several of those common drugs containing valsartan.
A study published last year in the medical journal BMJ found no "markedly increased short term overall risk of cancer" among users of the valsartan drugs contaminated with NDMA. Yet that study also noted that research into long-term cancer risk is needed.
Now, with NDMA being found in samples of ranitidine, "we are still investigating all ranitidine products and we are continuing to test additional samples," FDA spokesman Jeremy Kahn said in an email on Friday.
-snip-
Read more: https://edition.cnn.com/2019/09/13/health/fda-zantac-ranitidine-carcinogen-impurity-bn/index.html
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Related: Statement alerting patients and health care professionals of NDMA found in samples of ranitidine (U.S. Food & Drug Administration)
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