Diagnosis
Psychiatrists challenge FDA panel on antidepressants in pregnancy
Leading psychiatrists say a US panel promoted false claims about antidepressants in pregnancy, including that they are ineffective and linked to autism or birth defects.
The meeting on Monday featured 10 panellists, several of whom rejected the prevailing medical view on the safety of antidepressants during pregnancy.
They raised concerns about conditions such as autism, miscarriage and birth defects, and in some cases claimed depression resolves without treatment.
Three of the experts were based outside the US, while another runs a clinic that supports people stopping psychiatric medication.
Much of the discussion centred on selective serotonin reuptake inhibitors (SSRIs) such as Lexapro, Prozac and Zoloft, which boost serotonin levels in the brain to help improve mood.
Dr Joseph Goldberg is clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City.
He said: “They were really rousing concerns about safety that are not evidence-based or established and not at all balanced with concerns about the risks of untreated depression.”
Goldberg, a past president of the American Society of Clinical Psychopharmacology who has previously consulted for pharmaceutical companies, said he was invited to join the FDA panel but declined because the invitation suggested it would not be a fair discussion.
Dr Jennifer Payne, director of the Reproductive Psychiatry Research Programme at the University of Virginia, said: “I’m disappointed that the FDA brought people in from outside of the United States when there’s so many experts here in the United States who truly know this [medical] literature inside and out.”
The general medical consensus is that continuing SSRIs during pregnancy is often safer than stopping, particularly because untreated depression can lead to thoughts of self-harm or low birth weight.
Babies may sometimes show temporary symptoms such as irritability or jitteriness after birth – known as neonatal adaptation syndrome – which typically pass quickly.
While some studies have suggested a slightly higher risk of miscarriage, there is no solid evidence linking SSRIs with autism or birth defects.
“Well-controlled studies continue to not find an association,” said Payne.
Women with a history of depression are also at risk of recurrence during pregnancy, which carries its own potential harms.
One panellist, David Healy – a fellow of the Royal College of Psychiatrists in the UK – claimed: “It’s been said that SSRIs help people who are severely depressed. They don’t.”
Goldberg called that statement “simply untrue”, adding: “You can say the moon landing was faked. Conspiracy theories abound in our world. But there is not a doubt about whether SSRIs work.”
Psychologist Roger McFillin, who hosts a podcast critical of mainstream psychiatry, suggested depression is not an illness but an intense emotional state, particularly in women.
He also claimed, without evidence, that many women are pressured into taking antidepressants during pregnancy.
“I have never, ever, ever, ever heard of a third party pushing a prescription in pregnancy,” Goldberg said.
He added that some obstetrician-gynaecologists unfamiliar with SSRIs have wrongly advised patients to stop taking them.
The American College of Obstetricians and Gynecologists described the panel as “alarmingly unbalanced”.
In a statement, it said: “On a panel of 10 experts, only one spoke to the importance of SSRIs in pregnancy as a critical tool, among others, in preventing the potentially devastating effects of anxiety and depression when left untreated during pregnancy.”
That panellist was Dr Kay Roussos-Ross, a psychiatrist and obstetrician-gynaecologist at the University of Florida College of Medicine, who repeatedly questioned the panel’s conclusions.
“All of us can find a study that agrees with exactly what we think,” Roussos-Ross told the panel.
“But we need to look at the data very objectively.”
An FDA spokesperson defended the panel, saying Commissioner Martin Makary “has an interest in ensuring policies reflect the latest gold standard science and protect public health” and calling criticism of the event “insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels.”
The event followed Health and Human Services Secretary Robert F. Kennedy Jr’s call for a review of antidepressant use.
His “Make America Healthy Again” report warned of “potentially major long-term repercussions” from childhood use of the medications.
The FDA has granted accelerated approval to AstraZeneca drug Etcamah for certain adults with advanced breast cancer carrying an ESR1 mutation.
Etcamah, also known as camizestrant, was approved in combination with a CDK4/6 inhibitor, either abemaciclib, palbociclib or ribociclib.
The treatment is for adults with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer when an estrogen receptor-1 (ESR1) mutation is detected during aromatase inhibitor and CDK4/6 inhibitor therapy using an FDA-authorised test.
ESR1 mutations are acquired resistance mutations that tumours may develop during treatment with aromatase inhibitors, a type of endocrine therapy commonly used as a front-line treatment for locally advanced or metastatic breast cancer.
Fewer than 5 per cent of patients have the mutation when HR-positive metastatic breast cancer is diagnosed, according to the FDA. After disease progression on an aromatase inhibitor, nearly 40 per cent have the mutation.
Acting FDA commissioner Kyle Diamantas said: “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment.
“We owe them every weapon in our arsenal.
“Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
The accelerated approval programme allows earlier approval of drugs that treat serious conditions and fill an unmet medical need based on surrogate or intermediate endpoints.
For Etcamah, approval was based on how long patients lived without their disease worsening, measured from when the resistance mutation was first detected in their blood.
The FDA said it has not yet been confirmed whether intervening when the mutation is detected, rather than waiting until disease progression is confirmed, results in a clinically meaningful benefit. Confirmatory studies are therefore required to verify and describe clinical benefit.
Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said: “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval.
“This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing.
“But additional evidence is needed to confirm clinical benefit.”
Circulating tumour DNA, or ctDNA, consists of small pieces of tumour DNA released into the blood and can allow earlier molecular detection of resistance mutations.
The FDA also authorised the Guardant360 CDx assay as a companion diagnostic to identify patients with breast cancer who have ESR1 mutations for treatment with camizestrant.
Efficacy was assessed in a clinical trial comparing a switch to Etcamah plus a CDK4/6 inhibitor with continued treatment using an aromatase inhibitor plus a CDK4/6 inhibitor.
Estimated median progression-free survival was 16 months in the Etcamah group, compared with 9.2 months in the aromatase inhibitor group.
Etcamah’s prescribing information includes a boxed warning about the risk of irregular heart rhythm when taken with certain other medicines. It also includes warnings about an abnormally slow heart rate and potential harm to an unborn baby.
The FDA convened its Oncologic Drugs Advisory Committee for the application on 30 April 2026.
Four leading cardiovascular health groups have agreed new guidance for healthcare professionals assessing patients with suspected heart attacks.
Historically, some less common forms of heart attack, which evidence shows affect women far more than men, have been classified as less important, with treatment and care often worse as a result.
Experts said women had been receiving less effective treatments that did not always target the specific cause of their heart attack and could even make them more unwell.
The changes were announced in Munich on the opening day of the annual congress of the European Society of Cardiology (ESC).
Professor Bryan Williams, chief scientific and medical officer of the British Heart Foundation, said: “This is a landmark moment, a radical shift in how we define and diagnose heart attacks worldwide which will transform people’s care.
“For decades, women have missed out on accurate diagnoses and treatment.
“This focus on finding less common causes of heart attacks, which predominantly affect women, should help to change that. It could be life-changing for huge numbers of women in the UK and worldwide.”
The new guidance upgrades three types of heart attack that can be up to 10 times more common in women and are often caused by childbirth, exercise and emotional stress.
The most serious cases, previously known as “type 1” and now classed as “primary” heart attacks, had previously prioritised those caused by a clot blocking blood flow to the heart.
Other forms can involve reduced blood flow for different reasons, including the tightening or tearing of coronary arteries. These can be more likely to be missed or treated less urgently.
The guidance also introduces a lower diagnostic threshold for women based on levels of troponin, a protein released into the blood when the heart is injured and damaged.
Previously, women were expected to meet the same troponin threshold as men to receive a diagnosis.
Williams said the streamlined heart attack categories would also help patients understand the cause of their heart attack and what comes next.
The three upgraded types are coronary artery spasm, coronary embolism and spontaneous coronary artery dissection (SCAD).
Coronary artery spasm involves the tightening of an artery, which can deprive the heart muscle of blood and oxygen. It can be caused by emotional stress, exercise or extreme cold.
Coronary embolism occurs when a blood clot or fatty deposit travels to a coronary artery and causes a blockage.
SCAD is caused by a tear in a coronary artery. Around 80 per cent of cases occur in women, and it often happens during or soon after pregnancy.
Professor Nicholas Mills, a cardiologist at the University of Edinburgh who led the international taskforce behind the guidance, said it was “the first time that we’ve had a truly global approach to aligning how we diagnose what is probably the most important diagnosis there is”.
He said: “It kills so many people, and we’ve never got everyone together around the world to agree how we’re going to describe it, classify it, explain it to our patients.
“Our job now is to implement this as widely as possible. It’s just as relevant for the UK as it is for any other country around the world. It is a revolution. It’s going to make care better for patients.”
Mills said there had been “unintended systematic bias against women”, including through the use of the key blood test for diagnosing heart attacks at an average level, which picks up all men but misses some women.
He said: “This is used for all types of heart attack in every emergency department in the world, and we want to make sure that it’s used correctly.”
The guidance was drawn up by the ESC, the American College of Cardiology, the American Heart Association and the World Heart Federation.
Women’s health medical device company Ark Surgical has secured further institutional backing from JNF and the Israel Innovation Authority (IIA) as it accelerates the US commercial expansion of its surgical tissue containment technology.
Both organisations have previously backed Ark, making the renewed support a significant vote of confidence in the company’s technology, leadership team and commercial strategy as it moves into its next stage of growth.
The new backing comes alongside Ark Surgical’s ongoing Series A financing round, which has also attracted investment from physicians and experienced medical device executives, adding further industry validation as the company builds its US commercial presence.
The Israel Innovation Authority, Israel’s public agency supporting technological innovation, selected Ark Surgical for additional non-dilutive funding following an extensive evaluation process.
The assessment examined the unmet clinical need addressed by Ark’s technology, its clinical results, business and US go-to-market strategy, Israeli and US teams, execution against milestones and future product pipeline.
JNF, which supports economic development and community-building initiatives in Israel, has also increased its previous backing of Ark Surgical.
The relationship has particular significance given Ark’s roots in northern Israel. The company is headquartered near Nazareth in the Galilee and plans to continue strengthening its manufacturing capabilities in the region as its commercial presence in the US grows.
Together, the continued institutional support and investment from experienced healthcare leaders reflect growing confidence in Ark’s technology and its strategy for US expansion.
Stav Tori, CEO of Ark Surgical, said: “Having organisations that already know Ark, our technology and our team choose to support us again is particularly meaningful.
“It reflects our ability to consistently achieve the clinical, regulatory and commercial milestones we set and gives us additional resources to accelerate our expansion in the US.
“Our ambition goes beyond bringing another medical device to market.
“We want to help establish a higher standard of surgical safety for women undergoing minimally invasive procedures.”
Addressing an overlooked risk in women’s surgery
At the centre of Ark’s expansion is LapBox, the company’s FDA-cleared dual-wall tissue containment system developed to address an important safety challenge in minimally invasive gynecologic surgery.
Procedures such as hysterectomy and myomectomy can require large uterine specimens or fibroids to be divided into smaller pieces so they can be removed through small laparoscopic incisions.
This process, known as morcellation, carries a risk of disseminating tissue within the abdominal cavity.
In rare cases where an unsuspected malignancy is present, morcellation can spread malignant tissue and potentially worsen a patient’s prognosis.
But the risk is not limited to cancer.
Even benign uterine tissue can implant elsewhere in the abdominal cavity and grow, potentially resulting in complications such as parasitic fibroids and the need for additional treatment.
LapBox was developed as a dual-wall, bag-in-bag containment system that creates a secured chamber for tissue extraction. The device is FDA-cleared for use with both manual and power morcellation.
From clinical innovation to US adoption
Ark Surgical is now moving beyond its clinical and regulatory milestones to focus on broader commercial adoption.
LapBox™ has already been used in hundreds of procedures, while Ark has been expanding its presence within US hospitals and building relationships with leading minimally invasive gynecologic surgeons.
The latest institutional backing will support the next stage of that strategy, including additional hospital partnerships, key opinion leader engagement, sales leadership and clinical support.
Joseph LaBruzzo, President and CEO of U.S. Operations at Ark Surgical, said: “Ark has reached an important point in its development.
“We have the regulatory clearance, growing clinical experience and increasing engagement from US surgeons and hospitals.
“The focus now is execution and scale.
“What makes this continued backing particularly meaningful is that these are organizations that have followed Ark’s development and seen the team deliver against its objectives.
“Their decision to support the company again provides further validation as we build the commercial and clinical infrastructure needed for broader US adoption.”
That growing adoption is also being reflected in the experience of surgeons using LapBox.
Dr Ramon Yera, a minimally invasive gynecologic surgeon with more than 35 years of experience, said: “Once surgeons use LapBox, they realize this is the bag they should be using for their bread-and-butter procedures.”
Yera believes this reflects a broader shift in expectations around tissue containment in gynecologic surgery.
“Containment is no longer optional. It is an expectation.”
Ark Surgical is continuing its Series A financing round, with additional capital intended to support the next phase of US commercial expansion and development of its broader product pipeline.
Further information for prospective investors is available at ark-surgical.com/investment
Hormonal health2 weeks agoMajor UK study could be a ‘game-changer’ for heavy periods and endometriosis
Entrepreneur7 days agoKOVE Medical raises €1.7 million to improve safety of foetal surgery
Fertility2 weeks agoOne week left to apply: W Accelerate with Merck KGaA and M Ventures
Pregnancy1 week agoUK study aims to transform maternity care for high-risk pregnancies
Menopause2 weeks agoQuarter of women miss work due to menstual symptoms, survey finds
Mental health2 weeks agoPMDD after SSRIs or hormones: Why the brain may be the missing treatment target
Diagnosis2 weeks agoArk Surgical secures further institutional backing to accelerate US expansion
Menopause5 days agoMenopause hormone treatment may ease brain fog, study suggests