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    • Dr Reddys suspends...

    Dr Reddys suspends worldwide supply of Ranitidine over cancer fears until USFDA probe over

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 23 Sept 2019 4:30 AM  |  Updated On 16 Aug 2021 8:29 AM

    Ranitidine is an Over-The-Counter (OTC) and prescription drug which decreases the amount of acid created by the stomach.


    Hyderabad: Dr Reddy's Laboratories Limited on Sunday said that it is suspending supply of its drug Ranitidine worldwide as a precautionary measure, following the ongoing probe by the US Food and Drug Administration into the reported impurity N-nitrosodimethylamine in it at low levels.


    Ranitidine is an Over-The-Counter (OTC) and prescription drug which decreases the amount of acid created by the stomach.


    "Dr.Reddys is still evaluating the potential impact of the issue. As a precautionary measure, Dr Reddy's is suspending all shipments worldwide of Ranitidine products until the investigation (by the FDA) outcome is available. We have both a prescription and an over-the-counter portfolio of the product," Dr Reddy's spokesperson told in an email reply.


    The FDA in a statement on September 13 had said it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine being manufactured by several companies RPT being manufactured by several companies and examining levels of NDMA in Ranitidine and evaluating any possible risk to patients.


    Though the FDA is not calling for individuals to stop taking Ranitidine at this time, however, patients taking the prescription and wishing to discontinue its use should talk to their health care professionals about other treatment options, the US drug regulator said.


    "We expect to provide an update in the coming days. The FDA is not calling for individuals to stop taking Ranitidine at this time. Consumers and health care professionals should report any adverse reactions with Ranitidine to the FDA's MedWatch program to help the agency better understand the scope of the problem," Dr Reddys said.


    The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines such as Valsartan since last year.


    Aurobindo Pharma, Torrent Pharmaceuticals, Hetero Labs and many other multinationals have voluntarily recalled Valsartan from the USA market following alleged cancer-causing impurity-NDMA.


    Read Also: Dr Reddys gets EIR from USFDA for manufacturing plants at Duvvada

    Aurobindo Pharmablood pressureBPcancerDr Reddy'sDr Reddy's LaboratoriesDr Reddy's LabsDrug Recallheart failureHetero LabsHyderabadN-nitrosodimethylamineOTC drugpharmapharma newspharma news indiaprescription drugranitidinerecallTorrent PharmaUSUSFDAusfda investigationValsartan
    Source : PTI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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