Probable cancer-causing impurities in heartburn drugs like Zantac sparks reviewed


spaminator
#1
Probable cancer-causing impurities in heartburn drugs like Zantac sparks reviewed
Reuters
Published:
September 13, 2019
Updated:
September 13, 2019 1:57 PM EDT
Chief Marcelino Apurina, of the Aldeia Novo Paraiso in the Western Amazon region of Brazil, near Labrea holds a Babacu fruit, left, and ranitidine hydrochloride tablets, both used to treat gastric problems in traditional and modern medicine respectively on Sept. 21, 2017. (CARL DE SOUZA/AFP/Getty Images)
U.S. and European drug regulators said on Friday they are reviewing the safety of the widely taken heartburn drug ranitidine, commonly known by the brand name Zantac, after they found traces of a probable cancer-causing impurities in some versions of the medicine.
The U.S. Food and Drug Administration said it had found traces of the impurity, called N-nitrosodimethylamine (NDMA), in some versions of drugs with ranitidine in them. Both the FDA and the European Medicines Agency said they will review the drugs safety.
The impurities in ranitidine were first flagged to the regulators by Valisure, an online pharmacy that tests the medication its sells for flaws.
Valisure said in its report that it found the impurities in both Sanofi SAs branded Zantac as well as generic versions of the drug. But the FDA would not confirm in which versions of the drug it had found the impurities, noting that it found quite different and lower amounts of NDMA in the drugs.
NDMA is one of the impurities that has been found in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs). Regulators have been recalling those drugs since last year, and the FDA expanded its investigation of the impurities beyond that class of drugs last month.
Janet Woodcock, director of the FDAs Center for Drug Evaluation and Research, said in an interview that regulators around the world were considering requiring new testing during the manufacturing process to reduce contamination of drugs.
Were going to have to be more vigilant, Woodcock said. I think youll see tests added at the appropriate point during the manufacturing.
Blood pressure and heart failure medicines such as valsartan, the generic version of Novartis AGs Diovan, have been recalled by drugmakers such as Mylan NV, Teva Pharmaceutical Industries and Novartis Sandoz, as the drugs have been found to contain probable carcinogens.
http://torontosun.com/health/probabl...parks-reviewed
 
Cliffy
#2
 
Blackleaf
#3
At least you'd be able to console yourself that you no longer have heartburn.
 
spaminator
#4
Health Canada says four more companies recalling versions of Zantac
Reuters
Published:
September 25, 2019
Updated:
September 25, 2019 8:20 PM EDT
In this photo illustration, packages and pills of Zantac, a popular medication which decreases stomach acid production and prevents heartburn, sit on a table on Sept. 19, 2019 in New York City.Drew Angerer / Getty Images Photo Illustration
Health Canada said on Wednesday four more companies were recalling heartburn drug ranitidine, commonly known by its brand name Zantac, after presence of a probable cancer-causing impurity was found in some of the drugs.
The companies recalling the drugs include Apotex Inc, Pro Doc Limitee, Sanis Health Inc and Sivem Pharmaceuticals ULC, along with Novartis AGs recall, which was announced last week.
Probable cancer-causing impurities in heartburn drugs sparks review
Health Canada said the lots of the medicines being recalled may have been made using an active ingredient containing the impurity, N-nitrosodimethylamine (NDMA), above accepted levels.
NDMA is one of the impurities that has been found in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs), which regulators have been recalling since last year.
U.S. and European health regulators said earlier this month they were reviewing the safety of ranitidine. Canada last week requested makers of the drug to halt distribution as it gathers more information.
Branded versions of the drug such as Sanofi SAs Zantac are available for over-the-counter (OTC) sale in Canada, while generic versions are available for sale both OTC and with prescription.
http://torontosun.com/health/health-...ions-of-zantac