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Ranitidine Ban or Recall Case Study PharmacyNearMe
>> YOUR LINK HERE: ___ http://youtube.com/watch?v=zRokm1K40xs
Ranitidine | Ban or Recall ? Case Study | PharmacyNearMe • I am Sachin and you are watching our YouTube channel DrugDaddy. • FDA STATEMENT • Statement on new testing results, including low levels of impurities in ranitidine drugs : • Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives. Helping assure the quality and safety of these products is one of our greatest responsibilities. Over the past several weeks, the FDA has been investigating the detection of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, commonly known by the brand name Zantac. • We set out to fully understand this issue and provide actionable information for Americans who use these medications. The information we’ve gathered as part of our ongoing ranitidine investigation has been vital to answering the questions we’ve received about the potential risk of these products. Throughout this process, we’ve been updating our website with new information, and we are again providing an update with the latest information. • The agency has tested numerous ranitidine products on the market over the past few months, and today we’re releasing a summary of the results we have to date. Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats. We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process. Similarly, if ranitidine is exposed to a simulated small intestine environment, NDMA is not formed. However, we still must test the drugs in the human body to fully understand if ranitidine forms NDMA. • Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines. The calculated acceptable intake for NDMA in drugs is based on methods described in the 2018 ICH Guidance M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. If we or the manufacturers find NDMA levels above the acceptable limits (96 nanograms per day or 0.32 ppm), we’re now asking companies to voluntarily recall ranitidine. We would also ask manufacturers to voluntarily recall nizatidine, commonly known as Axid, if they found NDMA above the acceptable daily intake level because it is chemically similar to ranitidine. • We’re also asking manufacturers to continue conducting their own laboratory testing to examine levels of NDMA in ranitidine and nizatidine as well as to send samples to the FDA to be tested by our scientists. Additionally, we have requested that manufacturers of nizatidine test their drugs. We are still working with manufacturers to investigate the true source of NDMA and to understand the root cause of the low levels of NDMA present in the drugs. • Patients taking prescription ranitidine or nizatidine should speak with their health care professional about other treatment options. There are multiple drugs approved for the same or similar uses as ranitidine and nizatidine. Additionally, in our testing of ranitidine syrup, primarily used in neonates and pediatric patients, some samples yielded levels of NDMA above the acceptable daily intake level in some lots. Medicines with unacceptable levels are being recalled. We understand the concern we’ve been hearing from parents and pediatricians, and we’ll continue to investigate. Testing of ranitidine for injection is still ongoing. • We’ve been asked if testing methods have changed since these products were approved, and whether, in light of this situation, we should look at the safety of other older drugs. Drug manufacturers and the FDA continually gain knowledge about drugs, which is why the FDA constantly evaluates quality and safety information as it is learned. As testing methods have become more sophisticated and sensitive, the FDA and industry can identify and mitigate previously unknown risks to patients. This is something we are thoroughly aware of, and we have ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area to work to ensure similar impurities can be kept out of our drug supply. • Thank You • #DrugDaddy • #Ranitidin • #Pharmacy • ********************************************************* • Follow Us On Our Social Media Links: • Instagram : DrugDaddy • @drugdaddysg : / drugdaddysg • Facebook Page : DrugDaddy • @DrugDaddy : / drugdaddy
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