The FDA warns against unprecedented thyroid pills – so says that “will ensure access” to them

An unusual subject that was played at Food and Drug Administration in last week illustrated the power of Movement “Make America healthy”especially with its concentration on “Natural” drugs.

Last Thursday, the agency published a declaration To say that he had concerns about the safety and efficiency of non -approved thyroid drugs from animal tissue after receiving patient complaints and unwanted event reports. Consequently, the FDA said that it had informed manufacturers of drugs of its “intention to act” against the products, but added that it would not immediately give patients to change medication.

“The agency urges patients who take these thyroid drugs derived from unprecedented animals to treat hypothyroidism to speak to their doctor,” he wrote.

The declaration in itself was nothing surprising. Warnings on unsuccessful medicines are standard dishes for the FDA. What followed was not unknown either: the backlash of social media.

But Wednesday evening, the FDA commissioner, Marty Makary, apparently reversed the course, writing in a Poster on x The FDA is committed to continuing the very first approval of the dry thyroid extract, pending the results of the current clinical trials. “In the meantime, we will ensure access to all Americans,” he wrote.

Five minutes later, the Secretary of Health Robert F. Kennedy Jr. replied. “I love your approach to the use of the science of gold and common sense, @drmarkaryfda”, ” Kennedy wrote.

So what was it?

Animal derived thyroid pills

The thyroid – a small butterfly -shaped gland located at the front of the neck – helps to regulate the way the body uses energy by producing thyroid hormones. When it does not produce enough, it can cause hypothyroidism, which can cause symptoms, especially weight gain, fatigue, cold sensitivity, changes in menstrual cycles and symptoms of depression and anxiety, according to at the Mayo clinic. The condition is more frequent in women than men.

Standard treatment is prescription thyroid hormone replacement therapy – basically, taking pills that contain the necessary thyroid hormones. As a rule, one of the two synthetic hormones, levothyroxine or Liothyronine, or a combination of the two, are prescribed.

Some patients, however, turn to thyroid animal pills, either because they do not respond well to the synthetic versions or want to take something commercial as natural, said Dr. Michael Weintraub, endocrinologist at Nyu Langone Health in New York.

The pills – which are not approved by the FDA – are made from dried thyroid glands, generally from pigs, and are sold under marks such as armor thyroid, np thyroid, nature -thyroid and natural thyroid, according to the agency.

In the United States, approximately 1.5 million people were prescribed by thyroid pills derived from animals in 2024, the FDA said.

In the FDA declaration warning against drugs derived from animals, the agency said it could contain impurities that could cause infections and could also contain incoherent thyroid hormones levels, another risk for patients. Taking too much can cause undesirable effects, said FDA, and too few could not be effective.

The counterpoup

In the days following the FDA Declaration, patients and doctors went to social networks to express their opposition.

“The breakdown of the FDA to prohibit natural -dryed thyroid drugs. Millions depend on hypothyroidism which do not respond well to synthetic thyroid pharmaceuticals”, ” Read an article by Will ColeA doctor of functional medicine. “Let your voice be heard. The FDA must change its course on it.”

Dave Asprey, the founder of BulletProof Coffee, a brand of coffee and supplements, wrote: “I discovered that I had very low thyroid levels in the middle of the twenty, and hashimoto. Normal synthetic thyroid drugs did not work. The natural thyroid extract worked very well and I have been taking it for more than 25 years without problem.”

Dr Robert Malone – A Anti-Vaccin activist who was recently appointed by Kennedy in a vaccination panel – called The “terrible news – decision – especially for menopausal women”. He called on doctors and patients to contact the FDA in response.

Andrew Nixon, spokesperson for the Ministry of Health and Social Services, did not answer the question of whether the Makary post Wednesday was in response to the reaction of social media.

When asked if the FDA would always take measures against unprecedented thyroid products, Nixon returned NBC News to the agency’s declaration last week, which said: “The FDA does not take immediate measures against manufacturers who provide thyroid drugs derived from animals to treat their hypothyroidism.

Nixon added that the agency “will share additional information as it will become available and that the results of clinical trials are published”.

We do not know which trials in progress Makary and Nixon referred. Clinicaltrials.gov Enumerates an essay initiated by Walter Reed National Military Medical Center in 2012, but the status of the trial is currently marked as “unknown”. Allergan, the thyroid armor manufacturer, finished a test in 2021 Comparison of its product in levothyroxine, a synthetic thyroid hormone.

So, are these pills safe?

Dr. Pieter Cohen, an associate professor of medicine at the Harvard Medical School, said that the FDA was right to issue its initial warning concerning thyroid pills, noting that animal derived pills are not regulated by the agency and may present significant risks.

The synthetic versions approved by the FDA generally replace one of the two thyroid hormones: T4, the main hormone produced by the thyroid, or T3, the active form of T4 which helps to regulate energy and metabolism. Companies that manufacture drugs approved by the FDA must follow certain regulations, including the possibility of coherent dosage.

Animal derived versions also contain thyroid hormones, as well as prescription drugs, said Cohen, but because they are not regulated, the quantity they contain may be everywhere.

“Obtaining too little thyroid hormone presents long-term health risks,” he said. “If you take too much, it can damage your bones, it can damage your heart. If you take too little, if you don’t get enough, a certain number of problems can also occur, including mood problems, such as depression.”

Weintraub, of Nyu Langone Health, said that tiny changes in thyroid hormone levels can have a significant impact, so it is important to do the dosage. He noted that pigs naturally have much higher T3 levels than humans.

“This can cause disruption of heart rate, which can be fatal.

Weintraub said that he had patients who took thyroid pills derived from animals that had sleep problems, had a sensitivity to heat or osteoporosis.

Dr. Susan Spratt, endocrinologist and senior medical director of the Duke Health Management Office Population in North Carolina, however said that it would be unfair for the FDA of “suddenly drawn” the derived versions of the markets on the market “without dedicated reasons that they are harmful”.

Spratt has said that animal derived pills have existed for decades as a prescribable medication. (Weintraub said that animal derived drugs were “accelerated”, which means that they were already on the market before the current FDA standards were set up.)

While Spratt said she prefers to prescribe the synthetic versions approved by the FDA, the versions derived from animals offer an option to people who do not react well to synthetic.

“I would be welcomed by the NIH on the reasons why some patients do not feel as well on T4 products only,” she said.

Weintraub said that synthetic versions do not “necessarily like everyone’s symptoms, but there is a more precise and safer way of treating this than using pig or cow thyroids.”

He said that patients who do not react well to T4 or T3 drugs only often do better on a combination of the two.