{"id":6073,"date":"2019-09-30T18:02:48","date_gmt":"2019-09-30T22:02:48","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=6073"},"modified":"2020-07-13T19:59:03","modified_gmt":"2020-07-13T23:59:03","slug":"pharmacies-pull-zantac-ranitidine-recall","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/pharmacies-pull-zantac-ranitidine-recall\/","title":{"rendered":"FDA pulls all forms of ranitidine from U.S. market"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Ranitidine<\/span><span style=\"font-weight: 400;\">, commonly known by its brand name <\/span><span style=\"font-weight: 400;\">Zantac<\/span><span style=\"font-weight: 400;\">, is a medication that decreases stomach acid production. It\u2019s commonly taken to treat heartburn and GERD. On Sept. 13, 2019 the U.S. Food and Drug Administration(FDA) released a <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">statement<\/span><\/a><span style=\"font-weight: 400;\"> announcing the known presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) in some ranitidine medications, including Zantac\u2014prompting some drug stores to stop sales of all ranitidine products. On Apr. 1, 2020, the FDA asked drugmakers to pull all forms of ranitidine from the U.S. market.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Why is ranitidine being recalled?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u201cThe FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year,\u201d the original statement read. \u201cIn the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0T<\/span><span style=\"font-weight: 400;\">he original statement concluded that preliminary tests had confirmed ranitidine contains low levels of NDMA. This caused drug companies Novartis (which makes both Zantac and generic versions of the ranitidine medication) and Apotex (which makes Wal-Zan) to recall all of their generic ranitidine products sold in the US.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">Major pharmacy chains pulled Zantac off of their shelves. In a <\/span><a href=\"https:\/\/cvshealth.com\/newsroom\/press-releases\/cvs-pharmacy-statement-regarding-zantac-and-other-ranitidine-products\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">statement<\/span><\/a><span style=\"font-weight: 400;\">, CVS made it clear that \u201cthis action is being taken out of an abundance of caution,\u201d and the decision to pull ranitidine products from the shelves was made directly in reaction to the product alert from the U.S. Food and Drug Administration (FDA) stating that ranitidine products may contain a low level NDMA.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">In September, Ramzi Yacoub, Chief Pharmacy Officer of SingleCare, explained, \u201cThe FDA has recently detected some impurities in some ranitidine products and has issued a voluntary recall at the moment. This does not impact all ranitidine products at the moment. The FDA is continuing to test ranitidine products from different manufactures to further assess the potential side effects.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In April of this year, the FDA announced that after further investigation, the organization found NDMA levels increase over time in normal storage conditions. NMDA levels were also found to increase even more when ranitidine is stored at high temperatures. Meaning, consumers could be exposed to even greater amounts of NDMA. These findings prompted the FDA to issue a more stringent <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-requests-removal-all-ranitidine-products-zantac-market\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">recall request<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What to do if you take ranitidine<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Millions of Americans use ranitidine\u2014prescription-strength and over-the-counter\u2014to relieve various digestion problems. It\u2019s a widely used H2 blocker medication that blocks the action of histamine and reduces acid-production in the stomach. In fact, it\u2019s common for people to take it twice a day, or more. Those diagnosed with Zollinger-Ellison syndrome usually take ranitidine 3 times a day.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The FDA recommends that you speak to your doctor if you are taking prescription-strength ranitidine before stopping the medication. Anyone taking the over-the-counter strength should stop taking it, investigate alternatives with the help of a pharmacist, and return the medication for a refund. You can also report any adverse reactions or quality issues to the FDA&#8217;s <\/span><a href=\"https:\/\/www.fda.gov\/safety\/medwatch-fda-safety-information-and-adverse-event-reporting-program\/reporting-serious-problems-fda\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">MedWatch<\/span><\/a><span style=\"font-weight: 400;\"> Adverse Event Reporting program.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What are the alternatives?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Although ranitidine is recalled, anyone needing an <\/span><a href=\"https:\/\/www.hopkinslupus.org\/lupus-treatment\/common-medications-conditions\/gastrointestinal-medications\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">acid-reducing medication<\/span><\/a><span style=\"font-weight: 400;\"> can still find relief.\u00a0 Other H2 blockers, such as <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/pepcid-complete\"><span style=\"font-weight: 400;\">Pepcid<\/span><\/a><span style=\"font-weight: 400;\"> and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/tagamet-hb\"><span style=\"font-weight: 400;\">Tagamet<\/span><\/a><span style=\"font-weight: 400;\">, are still available over the counter to provide heartburn and indigestion relief, and have not been recalled.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">Antacids such as <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/rolaids-extra-strength\"><span style=\"font-weight: 400;\">Rolaids<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/tums\"><span style=\"font-weight: 400;\">Tums<\/span><\/a><span style=\"font-weight: 400;\">, and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/mylanta-maximum-strength\"><span style=\"font-weight: 400;\">Mylanta<\/span><\/a><span style=\"font-weight: 400;\"> can be good options for heartburn and indigestion relief. Additionally, proton pump inhibitors (PPIs) such as <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/nexium\"><span style=\"font-weight: 400;\">Nexium<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/prilosec\"><span style=\"font-weight: 400;\">Prilosec<\/span><\/a><span style=\"font-weight: 400;\">, and Prevacid can also provide relief without worrying about NDMA. However, PPIs are more potent and have some caveats that should be discussed with your doctor.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Talk to your doctor first<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">When switching medications, speak to a professional and learn the facts about what\u2019s available and considered a safe option for your specific needs. The FDA suggests considering other OTC products for your condition, if appropriate. Because most acid-reducing medications are only used for short-term treatment, your doctor may also decide to discontinue the medication.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cPatients who wish to discontinue ranitidine and change to another treatment option should discuss this with a medical professional,\u201d Dr. Yacoub advises. \u201cThere are other medications available in this same class or other classes to treat your condition\u2014but patients should consult with their pharmacist or doctor before making a change.\u201d<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ranitidine, commonly known by its brand name Zantac, is a medication that decreases stomach acid production. It\u2019s commonly taken to treat heartburn and GERD. On Sept. 13, 2019 the U.S. Food and Drug Administration(FDA) released a statement announcing the known presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) in some ranitidine medications, including Zantac\u2014prompting some [&hellip;]<\/p>\n","protected":false},"author":65,"featured_media":6063,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[788,72],"coauthors":[8722],"class_list":["post-6073","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-drug-safety","tag-fda","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA pulls all forms of ranitidine from U.S. market<\/title>\n<meta name=\"description\" content=\"Are you a user of Zantac or its generic? 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