{"id":1509268,"date":"2024-12-22T00:50:00","date_gmt":"2024-12-22T05:50:00","guid":{"rendered":"https:\/\/bugaluu.com\/news\/?p=1509268"},"modified":"2024-12-22T00:50:00","modified_gmt":"2024-12-22T05:50:00","slug":"fda-updates-recall-on-blood-pressure-medication-due-to-possible-carcinogen","status":"publish","type":"post","link":"https:\/\/bugaluu.com\/news\/fda-updates-recall-on-blood-pressure-medication-due-to-possible-carcinogen\/1509268\/","title":{"rendered":"FDA Updates Recall On Blood Pressure Medication Due To Possible Carcinogen"},"content":{"rendered":"

FDA Updates Recall On Blood Pressure Medication Due To Possible Carcinogen<\/span><\/p>\n

\n

Authored by Jack Phillips via The Epoch Times<\/a> (emphasis ours),<\/em><\/p>\n

A third blood pressure medication was recalled across the United States in the past several weeks<\/strong>, according to a notice updated on the U.S. Food and Drug Administration\u2019s (FDA) website on Dec. 16.<\/p>\n

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu\/The Epoch Times<\/em><\/a><\/p>\n

The notice said<\/a> that New Jersey-based Aurobindo Pharma USA Inc. is recalling Nebivolol tablets <\/strong>in 2.5 milligram doses in 30-count bottles, which are only available by prescription. Nebivolol, a type of beta blocker, is used to treat high blood pressure.<\/p>\n

The reason for the recall is because of the \u201cpresence of nitrosamine drug substance related impurity,<\/strong>\u201d adding that discovered N-nitroso nebivolol levels are above the \u201cacceptable intake limit,\u201d it said. N-nitroso nebivolol is a nitrosamine and is considered mutagenic.<\/p>\n

It was first initiated by Aurobindo earlier this month.<\/strong> The FDA classified the recall as Class II on Dec. 16, which occurs when there is a low chance of injury or death, and a possibility of \u201cadverse events\u201d that may have irreversible effects. They are issued if the product can cause medically reversible or temporary health problems\u2014or if there is a small chance of serious health consequences.<\/p>\n

The lot numbers being recalled are: NB0224001A and NB0224001B. It has an expiration date of April 2027 and a National Drug Code, or NDC, of 59651-137-30, according to the FDA.<\/p>\n

Nitrosamines are compounds that can increase the risk of cancer in individuals if exposed to them above levels established by the FDA, or for long periods of time, the agency says<\/a> on its website.<\/p>\n

\u201cA person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer<\/strong>,\u201d the FDA adds.<\/p>\n

People who are taking medications with possible \u201cnitrosamine impurities should not stop taking their medications\u201d and should instead speak with a health care professional.<\/p>\n

Nitrosamines can be found in small levels in the environment and foods, including \u201cmeat, vegetables, and dairy products,\u201d the FDA says<\/a>.<\/strong><\/p>\n

Some scientists have issued warnings about what they described as widespread nitrosamine contamination in pharmaceutical drugs, noting they are classified as class 1 known mutagenic impurities under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, a worldwide health body.<\/p>\n

In 2023, a Journal of Pharmaceutical Analysis-published research paper found<\/a> that the presence of the compounds \u201chas raised global safety concerns due to their significant genotoxic and mutagenic effects\u201d and that such \u201cimpurities,\u00a0even in trace amounts, are highly toxic and mutagenic, capable of damaging DNA, and subsequently increase the risk of cancer incidence.\u201d<\/p>\n

Other Recent Recalls<\/h2>\n

In the past two months, two other drugs used to treat high blood pressure were recalled across the United States, according to FDA recall notices.<\/p>\n

New York-based\u00a0Evaric Pharmaceuticals Inc. in November recalled<\/a> about 200,600 bottles of its Lisinopril tablets in 10-milligram doses after a \u201cpharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.\u201d <\/strong>The recall impacts Lisinopril tablets in 10-milligram strength in 90-count bottles.<\/p>\n

Weeks before that, Maryland-based Lupin Pharmaceuticals recalled another blood pressure medication, Ramipril, in October because the \u201cactive pharmaceutical ingredient was sourced from an unapproved vendor,\u201d the FDA said.<\/p>\n

The recall impacts Ramipril capsules in 2.5-milligram strength in 90-count, 100-count, and 500-count bottles, the notice said. The drug, an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure, is only available via a prescription.<\/p>\n<\/div>\n

Tyler Durden<\/a><\/span>
\nSat, 12\/21\/2024 – 19:50<\/span><\/p>\n

\u200bhttps:\/\/www.zerohedge.com\/medical\/fda-updates-recall-blood-pressure-medication-due-possible-carcinogen<\/a>\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"

FDA Updates Recall On Blood Pressure Medication Due To Possible Carcinogen Authored by Jack Phillips via The Epoch Times (emphasis ours), A third blood pressure…<\/p>\n","protected":false},"author":0,"featured_media":1509269,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1509268","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","wpcat-1-id"],"_links":{"self":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts\/1509268","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/comments?post=1509268"}],"version-history":[{"count":0,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts\/1509268\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/media\/1509269"}],"wp:attachment":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/media?parent=1509268"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/categories?post=1509268"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/tags?post=1509268"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}