Drs. Becca Ahrens-Nicklas & Kiran Musunuru joined the @FDA to announce a new “plausible mechanism” framework to speed approvals for rare diseases where large, randomized trials aren’t possible. This was inspired by their work w/ our patient KJ. More: http://ms.spr.ly/6013QkCPR.
Viewpoint by FDA Commissioner of Food and Drugs Martin Makary, MD, MPH, et al: Labeling changes for estrogen and progestogen products now emphasize individualized care, updated risk communication, and differences across systemic vs topical therapies.
https://ja.ma/4p1O1Rv
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication https://www.fda.gov/safety/medical-product-safety-information/fda-update-safety-ixchiq-chikungunya-vaccine-live-fda-suspends-biologics-license-fda-safety
Flot, nuanceret interview med @TracyBethHoeg, dansk-amerikansk læge, som jeg lærte at kende under pandemien, og som jeg er stolt over at kunne kalde min ven. Hendes bidrag til den amerikanske sundhedspolitik er baseret på data, ærlighed og sund fornuft - og også lidt hvad hun har taget med sig fra Danmark. https://www.berlingske.dk/internationalt/mor-jeg-har-ingen-grund-til-at-leve-mere-sagde-hendes-soen-i-det-oejeblik-vidste-dansk-laege-at-noget-var-galt-nu-er-hun-topraadgiver-i-trump-regeringen
If serotonin plays a crucial role in fetal development (which it does) & if SSRIs disrupt the serotonin system (which they do) then the SSRIs must alter fetal development - and the public should be warned.
This point was not disputed at yesterday's panel.
I was honoured to take part in the FDA's panel on the risks of SSRIs in pregnancy yesterday chaired by @DrMakaryFDA and @TracyBethHoeg. This is a huge issue with so many young women taking these drugs. I hope the UK and other countries will listen https://x.com/i/broadcasts/1yoKMowNValJQ
FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and ...
Important discussion regarding SSRIs (antidepressants) and pregnancy. Encourage all primary care doctors, therapists, psychologists, psychiatrists to view this debate and encourage their patients/clients to watch as well - especially women who are thinking about getting pregnant.
With 1 in 5 American's on a psychiatric drug, we may be getting a bit complacent about communicating the risks and benefits of prescribing SSRIs. They do affect fetal development, and they carry risks for the mother as well without clear benefit in randomized trials (however, randomized trials among pregnant women are not conducted - something that was discussed in this debate).
Are you informed? I learned a lot during this discussion. Highly recommend! https://www.youtube.com/live/2Nha1Zh63SA?si=cIbsWWLnOjQUG8yC via @YouTube
I never thought there'd be a day in which I'd be watching @DrMcFillin , @AdamUrato1 , @joannamoncrieff , @taperclinic , @LacasseJeffrey , and David Healy speak at the @US_FDA about the risks of taking SSRIs in pregnancy but here we are. Cheek-pinching moment. What a time of possibility we're in. Please watch and share-- this is big.
👏 The “new” FDA, under @DrMakaryFDA @MartyMakary is the most transparent, open, and engaging @US_FDA we have ever had!
No other FDA has so openly communicated and here they are live-streaming their expert panel on SSRI in pregnancy with @TracyBethHoeg
Strong work!!
10% is a very conservative estimate and we have witnessed an explosion of women taking an SSRI post 2020. A critical meeting and I am proud to have a seat at the table. We have been encouraged to speak from the heart. Thats all I know.
Over 10% of American women of childbearing age take SSRIs, with about half continuing use during pregnancy. However, questions remain about efficacy during pregnancy and potential risks to mother and child.
Join our expert roundtable THIS MONDAY, July 21 at 10 am for a comprehensive discussion on SSRI use in pregnancy. Livestreaming here!
Urgently needed FDA panel this coming Monday 21/7/25 including finest minds in this critical area: @AdamUrato1 , @DrDavidHealy, @LacasseJeffrey, @joannamoncrieff, @taperclinic, and more. Thanks so much to @DrMakaryFDA and @TracyBethHoeg for convening!
Approximately 5% of pregnant women take an SSRI for depression. But SSRI use during pregnancy has been linked in observational studies to birth defects, miscarriages, and neurological and behavioral challenges in childhood.
On Monday, July 21 at 10 a.m. ET, we’ll be hosting an expert panel to discuss this important issue, including the current state of science and FDA product labels.
Join us online: https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-selective-serotonin-reuptake-inhibitors-ssris-and-pregnancy-07212025
LIVE: FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women https://x.com/i/broadcasts/1ynKOlaPOoyGR
Honored to be a member of this panel. An opportunity to be authentically transparent- research backed information women on SSRI’s have not received. This is about informed consent and medical freedom
Hormone Replacement Therapy (HRT) has long been an important treatment option for women to alleviate symptoms of menopause, among other potential health benefits. Over the last two decades, however, HRT has been surrounded by confusing narratives about potential risks.
We're convening an expert panel at the FDA on July 17, 1-3 p.m. ET to discuss the latest evidence. Join us live at https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-menopause-and-hormone-replacement-therapy-women-07172025
The @US_FDA is leading a paradigm shift toward human-relevant testing! 🧪 This week’s workshop with FDA, @NIH & international experts highlighted novel strategies to move us away from traditional animal testing towards modern, human-relevant testing methods. These methods prioritize scientific advancement, patient safety, and efficiency. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-nih-workshop-reducing-animal-testing-07072025
Today, FDA provided important updates on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men.
The physician patient relationship is sacred and when the government tries to become your doctor, we don’t have a great track record. Our job at the FDA is to review data and decide whether products are safe and effective. The FDA is not your doctor.
🙏🏻 Wow. I was not aware of @realdocspeaks until today.
I really appreciate his kindness and remarkable accuracy👇🏻
A new article from the @US_FDA compares broad U.S. recommendations on Covid vaccination with those from other countries and announces the adoption of an evidence-based approach to such recommendations.
Read the full article: https://nej.md/3F6EIhV
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