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Health & Fit U.S. FDA says carcinogen not found in alternatives of Zantac and its generics

17:30  24 october  2019
17:30  24 october  2019 Source:   reuters.com

Zantac maker halts heartburn drug's distribution after cancer concerns

Zantac maker halts heartburn drug's distribution after cancer concerns Novartis said it's conducting its own investigation into traces of a potentially cancer-causing ingredient in Zantac

The U . S . Food and Drug Administration said on Wednesday that alternatives to popular heartburn drug Zantac and its generic versions, known chemically NDMA had previously been found in some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers, or ARBs.

U . S . retailers Walmart Inc, CVS Health Corp Walgreens Boots Alliance Inc and Rite Aid Corp have all removed Zantac off their shelves after some drugs containing its key ingredient ranitidine were found to have traces of the impurity, N-nitrosodimethylamine (NDMA).

Oct 23 (Reuters) - The U.S. Food and Drug Administration said on Wednesday that alternatives to popular heartburn drug Zantac and its generic versions, known chemically as ranitidine, have not been found to contain the probable cancer-causing impurity that ranitidine has been linked to. (http://bit.ly/2oYJ1Vz)

  U.S. FDA says carcinogen not found in alternatives of Zantac and its generics © golibtolibov/Getty Images

U.S. retailers Walmart Inc, CVS Health Corp Walgreens Boots Alliance Inc and Rite Aid Corp have all removed Zantac off their shelves after some drugs containing its key ingredient ranitidine were found to have traces of the impurity, N-nitrosodimethylamine (NDMA).

Related video: Zantac and its generic version found with chemical that could lead to cancer (CBS News)

Novartis and GlaxoSmithKline recall versions of generic Zantac

  Novartis and GlaxoSmithKline recall versions of generic Zantac Two drugmakers initiated recalls of generic versions of Zantac after testing found a probable carcinogen.Drug manufacturer Apotex said it's recalling 75 mg and 150 mg ranitidine tablets sold over the counter at the three chain pharmacies because the drugs might contain low levels of the cancer-causing impurity NDMA.

The FDA said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency. French drugmaker Sanofi SA last week

The FDA said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency. French drugmaker Sanofi SA last week

Early tests of alternatives to over-the-counter ranitidine, such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec show no NDMA, the agency said.

The FDA said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.

French drugmaker Sanofi SA last week said it would recall Zantac in the United States and Canada.

NDMA had previously been found in some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers, or ARBs. The potentially cancer-causing impurities are believed to have been introduced by recent changes in the manufacturing process for the drugs. (Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber)

FDA testing indicates Zantac does not form carcinogen in users .
The regulator said it still plans to test the drugs in human patients to fully understand whether it causes levels of the probable carcinogen N-nitrosodimethylamine (NDMA) to form in patients. Zantac, sold over-the-counter in the United States by French drugmaker Sanofi SA, and some of its generic versions, have been recalled due to possible NDMA contamination of pills that had not yet been consumed. The FDA said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine.

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