{"id":83397,"date":"2025-08-14T23:51:07","date_gmt":"2025-08-14T23:51:07","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/83397\/"},"modified":"2025-08-14T23:51:07","modified_gmt":"2025-08-14T23:51:07","slug":"fda-warns-about-unapproved-thyroid-pills-then-says-itll-ensure-access-to-them","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/83397\/","title":{"rendered":"FDA warns about unapproved thyroid pills \u2014 then says it’ll ‘ensure access’ to them"},"content":{"rendered":"

An unusual about-face that played out at the Food and Drug Administration over the last week illustrated the power of the \u201cMake America Healthy Again\u201d movement<\/a>, particularly with its focus on \u201cnatural\u201d drugs<\/a>. <\/p>\n

Last Thursday, the agency published a statement<\/a> saying it had concerns about the safety and effectiveness of unapproved thyroid medications made from animal tissue after it received complaints from patients and reports of adverse events. As a result, the FDA said it had notified drugmakers of its \u201cintent to take action\u201d against the products, but added that it wouldn’t do so immediately to give patients time to switch medications.<\/p>\n

\u201cThe agency urges patients taking these unapproved animal-derived thyroid medications to treat hypothyroidism to talk to their doctor,\u201d it wrote.<\/p>\n

The statement in and of itself was nothing surprising. Warnings about unapproved drugs are standard fare for the FDA. What followed also wasn\u2019t unheard of: social media backlash.<\/p>\n

But on Wednesday evening, FDA Commissioner Marty Makary seemingly reversed course, writing in a post on X that <\/a>the FDA was committed to pursuing the first-ever approval of desiccated thyroid extract, pending results of the ongoing clinical trials. \u201cIn the mean time, we will ensure access for all Americans,\u201d he wrote.<\/p>\n

Five minutes later, Health Secretary Robert F. Kennedy Jr. responded. \u201cLove your approach of using gold standard science and common sense, @DrMarkaryFDA,\u201d Kennedy wrote<\/a>. <\/p>\n

So, what was this all about?<\/p>\n

Animal-derived thyroid pills <\/p>\n

The thyroid \u2014 a small, butterfly-shaped gland located at the front of the neck \u2014 helps regulate how the body uses energy by producing thyroid hormones. When it doesn\u2019t produce enough, it can lead to hypothyroidism, which can cause symptoms including unexplained weight gain,<\/a> tiredness, sensitivity to cold, changes in menstrual cycles and symptoms of depression and anxiety, according to the Mayo Clinic<\/a>. The condition is more common in women than men.<\/p>\n

The standard treatment is prescription thyroid hormone replacement therapy \u2014 basically, taking pills that contain the needed thyroid hormones. Typically one of two synthetic hormones, levothyroxine or liothyronine, or a combination of both, are prescribed.<\/p>\n

Some patients, however, turn to animal-derived thyroid pills either because they don\u2019t respond well to the synthetic versions or want to take something marketed as natural, said Dr. Michael Weintraub, an endocrinologist at \u200b\u200bNYU Langone Health in New York City.<\/p>\n

The pills \u2014 which aren\u2019t FDA-approved \u2014 are made from dried thyroid glands, usually from pigs, and are sold under brand names like Armour Thyroid, NP Thyroid, Nature-Thyroid and Natural Thyroid, according to the agency.<\/p>\n

About 1.5 million people in the U.S. were prescribed animal-derived thyroid pills in 2024, the FDA said.<\/p>\n

In the FDA statement warning against the animal-derived drugs, the agency said they may contain impurities that could result in infections and could also contain inconsistent levels of thyroid hormones, another risk for patients. Taking too much can cause unwanted effects, the FDA said, and too little could not be effective.<\/p>\n

The backlash<\/p>\n

In the days that followed the FDA\u2019s statement, patients and doctors took to social media to voice their opposition.<\/p>\n

\u201cBREAKING FDA set to BAN natural desiccated thyroid medications. Millions rely on these for hypothyroidism who don\u2019t respond well to synthetic thyroid pharmaceuticals,\u201d read one post from Will Cole<\/a>, a functional medicine doctor. \u201cLet your voice be heard. The FDA needs to change course on this one.\u201d<\/p>\n

Dave Asprey, the founder of Bulletproof Coffee, a coffee and supplement brand, wrote<\/a>: \u201cI found out I had very low thyroid levels in my mid-20s, and Hashimoto\u2019s. Normal synthetic thyroid drugs did not work. Natural thyroid extract worked very well and I have been taking it for more than 25 years without a problem.\u201d<\/p>\n

Dr. Robert Malone \u2014 an anti-vaccine activist who was recently appointed by Kennedy to a vaccine advisory panel<\/a> \u2014 called<\/a> the decision \u201cterrible news \u2014 particularly for postmenopausal women.\u201d He called on doctors and patients to contact the FDA in response.<\/p>\n

Andrew Nixon, a spokesperson for the Department of Health and Human Services, did not respond to a question about whether Makary\u2019s post on Wednesday was in response to social media backlash. <\/p>\n

When asked about whether the FDA would still take action against unapproved thyroid products, Nixon referred NBC News to the agency\u2019s statement last week, which said, \u201cFDA is not taking immediate action against manufacturers who make unapproved animal-derived thyroid medication to give patients time to transition to an FDA-approved medication to treat their hypothyroidism.\u201d<\/p>\n

Nixon added that the agency \u201cwill share additional information as it becomes available and as clinical trial results are released.\u201d<\/p>\n

It\u2019s unclear which ongoing trials Makary and Nixon were referring to. ClinicalTrials.gov<\/a> lists a trial initiated by Walter Reed National Military Medical Center in 2012, but the trial\u2019s status is currently marked as \u201cunknown.\u201d Allergan, the maker of Armour Thyroid, completed a trial in 2021<\/a> comparing its product to levothyroxine, a synthetic thyroid hormone.<\/p>\n

So, are these pills safe?<\/p>\n

Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, said the FDA was correct to issue its initial warning about the thyroid pills, noting that the animal-derived pills aren\u2019t regulated by the agency and can pose significant risks. <\/p>\n

The FDA-approved synthetic versions usually replace one of two thyroid hormones: T4, the main hormone the thyroid produces, or T3, the active form of T4 that helps regulate energy and metabolism. Companies that make FDA-approved drugs must follow certain regulations, including consistent dosing. <\/p>\n

The animal-derived versions also contain the thyroid hormones, just like prescription medications, Cohen said, but because they\u2019re unregulated, the amount they contain can be all over the place. <\/p>\n

\u201cGetting too much or too little thyroid hormone has long-term health risks,\u201d he said. \u201cIf you take too much, it can damage your bones, it can damage your heart. If you take too little, if you\u2019re not getting enough, a number of problems can occur too, including mood problems, like depression.\u201d<\/p>\n

Weintraub, of \u200b\u200bNYU Langone Health, said that tiny changes in thyroid hormone levels can have a big impact, so it\u2019s important to get the dosage right. He noted that pigs naturally have much higher levels of T3 than humans.<\/p>\n

\u201cIt can lead to heart rhythm disturbances, which can be life-threatening. It can lead to bone degradation, which can lead to broken bones,\u201d he said.<\/p>\n

Weintraub said he\u2019s had patients who took animal-derived thyroid pills who\u2019ve had issues with sleeping, had sensitivity to heat or developed osteoporosis.<\/p>\n

Dr. Susan Spratt, an endocrinologist and senior medical director for the Population Health Management Office at Duke Health in North Carolina, however, said that it would be unfair for the FDA to \u201csuddenly yank\u201d the animal-derived versions from the market \u201cwithout dedicated reasons that they are harmful.\u201d<\/p>\n

Spratt said that the animal-derived pills have been around for decades as a prescribable drug. (Weintraub said the animal-derived drugs were \u201cgrandfathered in,\u201d meaning they were already on the market before current FDA standards for safety were put into place.)<\/p>\n

While Spratt said she prefers to prescribe the FDA-approved synthetic versions, the animal-derived versions offer an option for people who don\u2019t respond well to the synthetic ones.<\/p>\n

\u201cI would welcome NIH funding on why some patients don\u2019t feel as good on T4-only products,\u201d she said. <\/p>\n

Weintraub said the synthetic versions don\u2019t \u201cnecessarily help everyone\u2019s symptoms, but there\u2019s a more precise and safer way of treating that than resorting to a pig or cow thyroids.\u201d<\/p>\n

He said patients who don\u2019t respond well to T4- or T3-only medications often do better on a combination of the two.<\/p>\n","protected":false},"excerpt":{"rendered":"An unusual about-face that played out at the Food and Drug Administration over the last week illustrated the…\n","protected":false},"author":2,"featured_media":83398,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[97,243],"class_list":{"0":"post-83397","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/83397","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=83397"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/83397\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/83398"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=83397"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=83397"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=83397"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}