{"id":7308,"date":"2020-05-30T07:51:28","date_gmt":"2020-05-30T14:51:28","guid":{"rendered":"https:\/\/www.beliteweight.com\/blog\/?p=7308"},"modified":"2024-04-03T02:46:30","modified_gmt":"2024-04-03T09:46:30","slug":"fda-metformin-recall-weight-loss-surgery-and-diabetes","status":"publish","type":"post","link":"https:\/\/www.beliteweight.com\/blog\/fda-metformin-recall-weight-loss-surgery-and-diabetes\/","title":{"rendered":"FDA Metformin Recall &#8211; Weight Loss Surgery and Diabetes"},"content":{"rendered":"\n<div class=\"wp-block-image is-style-default\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"480\" height=\"237\" src=\"https:\/\/www.beliteweight.com\/blog\/wp-content\/uploads\/2020\/05\/FDA.png\" alt=\"\" class=\"wp-image-7311\" srcset=\"https:\/\/www.beliteweight.com\/blog\/wp-content\/uploads\/2020\/05\/FDA.png 480w, https:\/\/www.beliteweight.com\/blog\/wp-content\/uploads\/2020\/05\/FDA-300x148.png 300w\" sizes=\"auto, (max-width: 480px) 100vw, 480px\" \/><figcaption>FDA Recommends Voluntary Recall on Metformin Products<\/figcaption><\/figure><\/div>\n\n\n\n<p>On May 28, 2020 the FDA issued a press release announcing they contacted five manufactures of the diabetic medication, Metformin and recommended they voluntarily recall the drug due to contamination. <\/p>\n\n\n\n<p>The FDA will update their website as the companies respond (Link found HERE). As of the time of our blog only one company, Apotex Corp, has responded.<\/p>\n\n\n\n<p>This is a good time to mention that many studies have shown that weight loss surgeries have a 45-95% remission rate on Type 2 diabetes. This depends on the type of surgery the patient has. Surgeries such as the Gastric Bypass have shown to have the most effective long term weight loss and a higher effect on the glucoregulatory gut peptides producing one of the highest rate of remission <a rel=\"noreferrer noopener\" aria-label=\"(Study HERE) (opens in a new tab)\" href=\"https:\/\/spectrum.diabetesjournals.org\/content\/25\/4\/200\" target=\"_blank\">(Study HERE)<\/a>.<\/p>\n\n\n\n<p>From our own observations, many of our patients have reported back to us an immediate effect on their blood sugars. Some have not taken diabetic medication from the day of their surgery onward. <\/p>\n\n\n\n<p class=\"has-text-align-left has-medium-font-size\"><strong>For more information on the surgeries offered and our surgeons call 1-800-215-6497<\/strong><\/p>\n\n\n\n<p>The full press release is below:<\/p>\n\n\n\n<p>FDA News Release<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_79_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.beliteweight.com\/blog\/fda-metformin-recall-weight-loss-surgery-and-diabetes\/#FDA_Alerts_Patients_and_Health_Care_Professionals_to_Nitrosamine_Impurity_Findings_in_Certain_Metformin_Extended-Release_Products\" >FDA Alerts Patients and Health\n Care Professionals to Nitrosamine Impurity Findings in Certain \nMetformin Extended-Release Products<\/a><ul class='ez-toc-list-level-2' ><li class='ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.beliteweight.com\/blog\/fda-metformin-recall-weight-loss-surgery-and-diabetes\/#Agency_Continues_Investigations_of_Nitrosamine_Impurities_in_Drug_Products\" >Agency Continues Investigations of Nitrosamine Impurities in Drug Products<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h1 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Alerts_Patients_and_Health_Care_Professionals_to_Nitrosamine_Impurity_Findings_in_Certain_Metformin_Extended-Release_Products\"><\/span>FDA Alerts Patients and Health\n Care Professionals to Nitrosamine Impurity Findings in Certain \nMetformin Extended-Release Products <span class=\"ez-toc-section-end\"><\/span><\/h1>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Agency_Continues_Investigations_of_Nitrosamine_Impurities_in_Drug_Products\"><\/span>Agency Continues Investigations of Nitrosamine Impurities in Drug Products<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\n  \n    \n  \n\n \n\n\n  \n\n\n\n\n\n\n                      \n                              \n                                                                           \n\n                            \n                            \n                            \n                            \n                                              \n    \n    \n        For Immediate Release:\n                  May 28, 2020\n\n                 \n                \n      \n    \n \n\n  <\/p>\n\n\n\n<p>The U.S. Food and Drug Administration is announcing  today that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency\u2019s  acceptable intake limit in several lots of the extended-release (ER)  formulation of metformin, a prescription drug used to control high blood  sugar in patients with type 2 diabetes. The agency is in contact with  five firms to recommend they voluntarily recall their products. Company  recall notices will be posted on FDA\u2019s website.  There are additional manufacturers of the metformin ER formulation that  supply a significant portion of the U.S. market, and their products are  not being recalled. The FDA is continuing to work closely with  manufacturers to ensure appropriate testing. Assessments are underway to  determine whether metformin ER recalls will result in shortages and the  agency will work closely with manufacturers to prevent or reduce any  impact of shortages.<\/p>\n\n\n\n<p>\u201cThe FDA has strict standards for safety, effectiveness and quality, \nand the agency makes every effort based on science and data to help keep\n the U.S. drug supply safe. We understand that patients may have \nconcerns about possible impurities in their medicines, and want to \nassure the public that we have been looking closely at this problem over\n many months in order to provide patients and health care professionals \nwith clear and accurate answers,\u201d said Patrizia Cavazzoni, M.D., acting \ndirector of the FDA\u2019s Center for Drug Evaluation and Research. \u201cNow that\n we have identified some metformin products that do not meet our \nstandards, we\u2019re taking action. As we have been doing since this \nimpurity was first identified, we will communicate as new scientific \ninformation becomes available and will take further action, if \nappropriate.\u201d<\/p>\n\n\n\n<p>Patients should continue taking metformin tablets even after recalls \noccur, until they consult with their health care professional who can \nprescribe a replacement. Patients with type 2 diabetes could face \ndangerous health risks if they stop taking their prescribed metformin. \nThe FDA recommends that health care professionals continue to prescribe \nmetformin when clinically appropriate; FDA testing has not shown NDMA in\n immediate release (IR) metformin products (the most commonly prescribed\n type of metformin). The agency is working with manufacturers of the \nrecalled tablets to identify the source of the NDMA impurity. At this \ntime, the elevated levels of NDMA have been found in some finished-dose \ntablets of the ER formulation but have not been detected NDMA in samples\n of the metformin active pharmaceutical ingredient.<\/p>\n\n\n\n<p>The agency is also asking all manufacturers of metformin containing \nER products to evaluate the risk of excessive NDMA in their product and \nto test each batch before it is released into the U.S. market. If \ntesting shows NDMA above the acceptable intake limit, the manufacturer \nshould inform the agency and should not release the batch to the U.S. \nmarket.<\/p>\n\n\n\n<p>In late 2019, the FDA announced\n it had become aware of NDMA in some metformin products in other \ncountries. The agency immediately began testing to determine whether the\n metformin in the U.S. supply was at risk, as part of the ongoing \ninvestigation into nitrosamine impurities across medication types. By \nFebruary 2020, the agency had identified very low levels\n of NDMA in some samples, but at that time, no FDA-tested sample of \nmetformin exceeded the acceptable intake limit for NDMA. The FDA has \nmaintained that it would continue with ongoing testing of metformin and \nother medications, and if any levels of NDMA or other impurities were \nidentified, swift action would be taken.<\/p>\n\n\n\n<p>Recently, the FDA became aware of reports of higher levels of NDMA in\n certain ER formulations of metformin via a citizen petition filed by a \nprivate laboratory. FDA laboratories tested the same metformin lots that\n the private laboratory found to contain NDMA above the acceptable \nintake limit. The agency confirmed unacceptable NDMA levels in some, but\n not all, of those lots. In other instances, our laboratory detected \nNDMA in lots that the private laboratory did not. The agency also found \nthat the levels of NDMA, when present, were generally lower than \nreported by the private laboratory. Given FDA scientists\u2019 deep \nexperience quantifying these impurities in drugs, the agency is \nconfident in the reliability of the FDA\u2019s testing method and results and\n will continue to take action based on the latest scientific \ninformation. The results have also been consistent with the findings of \nother regulatory agencies\u2019 laboratories around the world.<\/p>\n\n\n\n<p><strong>Additional Information<\/strong><\/p>\n\n\n\n<p>NDMA is a common contaminant found in water and foods including cured\n and grilled meats, dairy products and vegetables. Everyone is exposed \nto some level of NDMA. The FDA and the international scientific \ncommunity do not expect it to cause harm when ingested at low levels. \nThe FDA\u2019s acceptable intake limit for NDMA in drug formulations is 96 \nnanograms per day. The FDA does not expect nitrosamines to cause harm \nwhen ingested at or below the acceptable intake limit levels (such low \nlevels of nitrosamines are present in foods in low levels and ingested \nas part of usual diets) even over a long period of time (such as a \n70-year lifespan). Nitrosamine impurities may increase the risk of \ncancer if people are exposed to them at above-acceptable levels over \nlong periods of time, but we do not anticipate that shorter-term \nexposure at levels above the acceptable intake limit would lead to an \nincrease in the risk of cancer. We are working to ensure medicines on \nthe U.S. market do not exceed the acceptable intake limit.<\/p>\n\n\n\n<p>The FDA has previously investigated the presence of nitrosamines in \nthe U.S. drug supply. The investigation began with the blood pressure \nand heart failure medicines called angiotensin II receptor blockers (ARBs) and later expanded to include heartburn medicines, ranitidine and nizatidine, as well as diabetes medication, metformin and other medicines. In April 2020, the agency requested manufacturers\n withdraw all prescription and over-the-counter (OTC) ranitidine drug \nproducts from the market because of test results showing that NDMA in \nsome ranitidine products increases over time and, when stored at higher \nthan room temperatures, may result in consumer exposure to unacceptable \nlevels of this impurity.<\/p>\n\n\n\n<p>There are multiple reasons for the presence of NDMA in drugs. The FDA\n has previously found that the source of NDMA can be related to the \ndrug\u2019s manufacturing process or its chemical structure or even the \nconditions in which they are stored or packaged. As food and drugs are \nprocessed in the body, nitrosamines, including NDMA, can be formed.<\/p>\n\n\n\n<p>The FDA is taking a systematic approach to identify medicines with \nnitrosamines above the acceptable intake limit and remove them from the \nmarket. Improved technology enables the detection of even trace amounts \nof impurities in drug products and may be the reason why more products \nhave been found to have low levels of NDMA. Today, better testing \nmethods exist, and the FDA better understands the specific manufacturing\n steps that may increase the risk of nitrosamine formation. The FDA \nworks closely with international drug regulatory agencies, who have also\n been testing drug products for NDMA and are collaborating to \ninvestigate the sources of these impurities.<\/p>\n\n\n\n<p>The FDA, an agency within the U.S. Department of Health and Human \nServices, protects the public health by assuring the safety, \neffectiveness, and security of human and veterinary drugs, vaccines and \nother biological products for human use, and medical devices. The agency\n also is responsible for the safety and security of our nation\u2019s food \nsupply, cosmetics, dietary supplements, products that give off \nelectronic radiation, and for regulating tobacco products.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On May 28, 2020 the FDA issued a press release announcing they contacted five manufactures of the diabetic medication, Metformin and recommended they voluntarily recall the drug due to contamination. The FDA will update their website as the companies respond (Link found HERE). As of the time of our blog only one company, Apotex Corp, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7311,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14,27,6,18,4],"tags":[50,16,245],"class_list":["post-7308","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-weight-loss-surgery","category-bariatric-surgery","category-gastric-bypass","category-general","category-health","tag-diabetes","tag-gastric-bypass-surgery","tag-weight-loss-surgery-for-diabetics"],"_links":{"self":[{"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/posts\/7308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/comments?post=7308"}],"version-history":[{"count":14,"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/posts\/7308\/revisions"}],"predecessor-version":[{"id":9311,"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/posts\/7308\/revisions\/9311"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/media\/7311"}],"wp:attachment":[{"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/media?parent=7308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/categories?post=7308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.beliteweight.com\/blog\/wp-json\/wp\/v2\/tags?post=7308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}