Developments in vaccines / drug safety

[ken_sylvania]

That tweet was from 2017 as you can see from the date. Their corporate twitter feed has been inactive since 2021. And Tylenol has clarified it and says it has been taken out of context: https://www.audacy.com/krld/news/nation ... resurfaces



In other words, drug companies are legally not in the position of recommending specific products for specific people. That is the role of doctors and other medical professionals with knowledge of the particular patient in question.

In what way is it being taken out of context? What was the context in which it was posted?
I would have thought for all the furor about it some responsible journalist would have checked to see and provided a screenshot of the context of the original post.
I guess "inactive since 2021" means they still were using and posting with the account three years later....

I think it's safe to assume that if they really thought it was risky during pregnancy that information would have been somewhere easier to find than an eight year old tweet. Like maybe on the label.

Oh I certainly agree with that. For the record, I'm rather skeptical about this idea that Tylenol is particularly dangerous for pregnant people.
I'm just saying that if the claim is that the statement is being taken out of context, there must have been a context in which the statement was made that would materially change its meaning.

The label and product info specifically call out pregnant and nursing women and infants as individuals for whom a doctors recommendation should be sought before using the product. Soloist mentioned some of the reasons.

[ken_sylvania]

It is taken out of context because drug companies can't actually legally recommend their products for any specific patients. That is the role of doctors and medical professionals.

So the context isn't that Tylenol thinks it is unsafe for pregnant women to take their products. But rather, you need to speak with your doctor to find out what products are recommended for your specific condition.

Is that why the label gives dosing information for adults and children, then says that if you have liver disease or if you are pregnant or nursing you should consult a doctor before taking it?

Why do they recommend consulting with a doctor for only certain subgroups of potential users? Think it might have anything to do with either higher risks or less available safety data for those groups?

[Ken]

It is taken out of context because drug companies can't actually legally recommend their products for any specific patients. That is the role of doctors and medical professionals.

So the context isn't that Tylenol thinks it is unsafe for pregnant women to take their products. But rather, you need to speak with your doctor to find out what products are recommended for your specific condition.

Is that why the label gives dosing information for adults and children, then says that if you have liver disease or if you are pregnant or nursing you should consult a doctor before taking it?

Why do they recommend consulting with a doctor for only certain subgroups of potential users? Think it might have anything to do with either higher risks or less available safety data for those groups?

Read the label again.

It does not recommend that any particular patient take the drug or not take it.

It provides a list of conditions that it is used for (fever, headaches, etc.), provides general dosage information, and then lists some conditions for which you should consult a medical professional before taking. Liver disease, pregnant women, children under 12, etc.

The detailed FDA risk profile says that acetaminophen is the drug of choice for pregnant women and that the benefits outweigh the risks and make no mention of autism: https://www.drugs.com/pregnancy/acetaminophen.html

If that needs to change based on new evidence then there is a rigorous scientific-based process by which that needs to be done. It doesn't involve the president going on TV and spouting misinformation and rumor.

[ken_sylvania]

It is taken out of context because drug companies can't actually legally recommend their products for any specific patients. That is the role of doctors and medical professionals.

So the context isn't that Tylenol thinks it is unsafe for pregnant women to take their products. But rather, you need to speak with your doctor to find out what products are recommended for your specific condition.

Is that why the label gives dosing information for adults and children, then says that if you have liver disease or if you are pregnant or nursing you should consult a doctor before taking it?

Why do they recommend consulting with a doctor for only certain subgroups of potential users? Think it might have anything to do with either higher risks or less available safety data for those groups?

Read the label again.

It does not recommend that any particular patient take the drug or not take it.

It provides a list of conditions that it is used for (fever, headaches, etc.), provides general dosage information, and then lists some conditions for which you should consult a medical professional before taking. Liver disease, pregnant women, children under 12, etc.

In other words - precisely what I said.
The label says certain subgroups of potential users that should consult a doctor, which certainly implies that other users need not consult a doctor before use.

Do you think the reason for recommending certain people consult with a doctor is because there is either less available safety data or a higher risk for those groups? Or did they just chose those groups at random because they like to discriminate against pregnant women or people with liver disease?

[Ken]

Is that why the label gives dosing information for adults and children, then says that if you have liver disease or if you are pregnant or nursing you should consult a doctor before taking it?

Why do they recommend consulting with a doctor for only certain subgroups of potential users? Think it might have anything to do with either higher risks or less available safety data for those groups?

Read the label again.

It does not recommend that any particular patient take the drug or not take it.

It provides a list of conditions that it is used for (fever, headaches, etc.), provides general dosage information, and then lists some conditions for which you should consult a medical professional before taking. Liver disease, pregnant women, children under 12, etc.

In other words - precisely what I said.
The label says certain subgroups of potential users that should consult a doctor, which certainly implies that other users need not consult a doctor before use.

Do you think the reason for recommending certain people consult with a doctor is because there is either less available safety data or a higher risk for those groups? Or did they just chose those groups at random because they like to discriminate against pregnant women or people with liver disease?

The FDA used to have a whole letter-based classification system for drug risk in pregnancy. Class A drugs were those for which rigorous double-blind testing found no risk to pregnant women. Almost no drugs fell into this category because large-scale drug testing on pregnant women isn't usually done. Most including common OTC meds like Pepto-Bismol, Vitamin B and acetaminophen were classified as Category B which meant that animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Drugs with potential higher risks to pregnant women were classified as C, D, or X depending on the severity of the risk. Aspirin was classified as Category D, for example and advised against except for rare cases. They have changed that system to more of a descriptive system but acetaminophen is still classified as low risk and the medicine of choice for pregnant women with fever.

So, for example, Pepto-Bismol contains the same exact warning for pregnant women as Tylenol but no one really thinks that Pepto-Bismol poses risks to pregnant women or causes autism. They just haven't done a huge Pepto-Bismol study on pregnant women to make sure. This is the Pepto-Bismol label

[Ken]

And here is the label for Folic Acid (Vitamin B9) which contains the same label information as Tylenol. In fact, the Cleveland Clinic says that Folic Acid "is the most important vitamin you need during pregnancy." https://my.clevelandclinic.org/health/d ... l-vitamins

No one thinks that Folic Acid poses health risks to pregnant women or causes autism but because they haven't done rigorous double-blind studies on pregnant women it gets the same label information as Tylenol. Even the labels for prenatal vitamins say that you should only take them under the supervision of a medical professional.



It may well be the case that new evidence will lead to a reclassification and relabeling of acetaminophen. But we haven't gone through that process yet. Acetaminophen remains the medicine of choice to treat fever in pregnancy and fever during pregnancy does pose real and known risks to the fetus.

[JohnH]

Ken,

Do you have any commentary on this?



This is a statement from the drug manufacturer on their official account./

[mike]

Ken,

Do you have any commentary on this?



This is a statement from the drug manufacturer on their official account./

They didn't really mean that

[Ken]

You're calling me out to comment on an 8-year old tweet from Tylenol? I don't have any great love of big pharma but I will defend basic science. In any event, Tylenol addressed this tweet today in the New York Times saying it was taken out of context and a actually a response to a since deleted tweet from someone else: https://www.nytimes.com/2025/09/25/us/p ... =url-share

Tylenol Issues Clarification After White House Resurfaces 2017 Tweet on Usage During Pregnancy

Tylenol’s parent company, Kenvue, said an eight-year-old social media post was “being taken out of context” as the Trump administration warns pregnant women not to take the drug.

By Jenny Gross
Sept. 25, 2025

The parent company of Tylenol, the over-the-counter pain reliever, on Thursday sought to clarify a 2017 social media post in which it said that it did not recommend taking “any of our products while pregnant.”

The Trump administration had highlighted the old post on Wednesday, two days after its announcement urging pregnant women to avoid taking Tylenol, claiming without new evidence that it was a cause of autism.

The Department of Health and Human Services’s X account resurfaced the post, writing, “No caption needed.” The White House’s account also shared the 2017 post.

Tylenol’s parent company, Kenvue, said in a statement on Thursday that the eight-year-old post, made in response to a now-deleted tweet from a customer — was now being “taken out of context.”

The response was “incomplete and did not address our full guidance on the safe use of Tylenol which has not changed: Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” Kenvue said, referring to the active ingredient in Tylenol.

The statement added: “We recommend pregnant women do not take any over-the-counter medication, including acetaminophen, without talking to their doctor first.”

President Trump and his health secretary, Robert F. Kennedy Jr., on Monday warned against pregnant women taking acetaminophen at a White House news conference, citing unproven claims that the drug could cause autism.

“Don’t take Tylenol,” Mr. Trump said. “Fight like hell not to take it,” he said, adding that if someone did take it, “That, you’ll have to work out with yourself.” He repeatedly insisted there was “no downside” to avoiding it, except in rare instances, such as a dangerously high fever.

In response, the American College of Obstetricians and Gynecologists said on Monday that the suggestion that acetaminophen use in pregnancy caused autism was not backed by reliable data and “dangerously simplifies the many and complex causes of neurologic challenges in children.”

“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children,” Steven J. Fleischman, the president of the college, said in a statement. He added, “Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated.”

Decades of studies have shown a strong association between fevers early in pregnancy and a specific set of birth defects, including neural tube defects, some heart defects and cleft palates, according to Dr. Eric Benner, a neonatologist at Duke University.

What I will comment on is that this whole fiasco is really an attempt at butt covering by RFJ Jr. who last April promised the nation that they would undertake a massive testing and research effort to determine the cause of autism in five months. Which was a farcical promise to make given how complex the issue is. And here we are 5 months later and they have basically nothing to show for it so they come out and tout leucovorin as an autism cure when the drug is only in the very preliminary stages of research. And they hammer acetaminophen use in pregnancy as linked to autism when again, the evidence for that is very circumstantial and highly disputed. It basically feels like they are just trying to throw things at the wall to see if something sticks to cover their butts for not actually having anything legitimate to report.

This is all so ridiculous. We don't do science based on old tweets by some PR lackey running a parma company's twitter feed. Which is probably why companies like Tylenol no longer let their PR staff tweet on social media. And we don't do science based on false rumors and made-up nonsense tossed out by presidents in press conferences.

[Valerie]

You're calling me out to comment on an 8-year old tweet from Tylenol? I don't have any great love of big pharma but I will defend basic science. In any event, Tylenol addressed this tweet today in the New York Times saying it was taken out of context and a actually a response to a since deleted tweet from someone else: https://www.nytimes.com/2025/09/25/us/p ... =url-share

Tylenol Issues Clarification After White House Resurfaces 2017 Tweet on Usage During Pregnancy

Tylenol’s parent company, Kenvue, said an eight-year-old social media post was “being taken out of context” as the Trump administration warns pregnant women not to take the drug.

By Jenny Gross
Sept. 25, 2025
Updated 9:11 a.m. ET
The parent company of Tylenol, the over-the-counter pain reliever, on Thursday sought to clarify a 2017 social media post in which it said that it did not recommend taking “any of our products while pregnant.”

The Trump administration had highlighted the old post on Wednesday, two days after its announcement urging pregnant women to avoid taking Tylenol, claiming without new evidence that it was a cause of autism.

The Department of Health and Human Services’s X account resurfaced the post, writing, “No caption needed.” The White House’s account also shared the 2017 post.

Tylenol’s parent company, Kenvue, said in a statement on Thursday that the eight-year-old post, made in response to a now-deleted tweet from a customer — was now being “taken out of context.”

The response was “incomplete and did not address our full guidance on the safe use of Tylenol which has not changed: Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” Kenvue said, referring to the active ingredient in Tylenol.

The statement added: “We recommend pregnant women do not take any over-the-counter medication, including acetaminophen, without talking to their doctor first.”

President Trump and his health secretary, Robert F. Kennedy Jr., on Monday warned against pregnant women taking acetaminophen at a White House news conference, citing unproven claims that the drug could cause autism.

“Don’t take Tylenol,” Mr. Trump said. “Fight like hell not to take it,” he said, adding that if someone did take it, “That, you’ll have to work out with yourself.” He repeatedly insisted there was “no downside” to avoiding it, except in rare instances, such as a dangerously high fever.

In response, the American College of Obstetricians and Gynecologists said on Monday that the suggestion that acetaminophen use in pregnancy caused autism was not backed by reliable data and “dangerously simplifies the many and complex causes of neurologic challenges in children.”

“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children,” Steven J. Fleischman, the president of the college, said in a statement. He added, “Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated.”

Decades of studies have shown a strong association between fevers early in pregnancy and a specific set of birth defects, including neural tube defects, some heart defects and cleft palates, according to Dr. Eric Benner, a neonatologist at Duke University.

Of course they would say that.
How high does a fever have to be, to become a risk to the fetus? Obviously as President Trump said in that case take the Tylenol right?

Obviously this wasn’t President Trumps own research leading to this announcement so who’s been doing the research.

Obviously “something” has caused the rise in autism. I work with several functioning autistic employees, each with their own unique issues- I am quite sure they’d all love for the cause to be solved- part of the announcement was also about helping autistics. Also Tylenol was not the only possible cause. It would be so awesome to get this solved for both parents and autistic children.