Latest news with #SSRIs
Los Angeles Times
9 hours ago
- Health
- Los Angeles Times
FDA panel on the use of antidepressants during pregnancy is alarming experts
The U.S. Food and Drug Administration is turning its attention to selective serotonin reuptake inhibitors, a class of antidepressant drugs long criticized by Health and Human Services Secretary Robert F. Kennedy Jr. On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications like fluoxetine (Prozac), sertraline (Zoloft) and citalopram (Celexa), among others. Nine of the panel's 10 members were researchers, doctors or psychologists who have previously questioned the safety of SSRIs publicly or spoken out against antidepressant use in general. Over the course of the discussion, several panel members cited studies that lacked appropriate controls, physicians not involved with the panel said. In other words, there was no way to be certain on the basis of the studies whether the observed health problems were caused by SSRIs, the underlying mood disorder or some other factor. Other participants described study findings inaccurately or incompletely, said outside experts. For example, few panelists considered the risks of SSRI use relative to the risks associated with untreated depression, which also contributes to poor outcomes for children and mothers. In the U.S., suicide is a leading cause of maternal death in the first year of a baby's life. An FDA spokesperson said the panel was part of the agency's 'broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight' and did not respond to further queries about the agency's potential next steps. But healthcare professionals expressed concern that the panel could ultimately prevent women from getting the care they need. 'I was surprised and disappointed by the amount of misinformation that was presented,' said Dr. Katie Unverferth, a reproductive psychiatrist and medical director of UCLA's Maternal Mental Health Program. 'When we look at the body of data ... we find that there are no consistent associations [of] SSRIs with cardiac defects, pulmonary hypertension or neurodevelopmental issues in offspring,' she said, naming some of the harms panelists attributed to the drugs. 'This misinformation just creates intrusive thoughts. It's not helpful.' The panel included just one specialist in maternal mood disorders — Dr. Kay Roussos-Ross, an obstetrician-gynecologist and director of the Perinatal Mood Disorders Program at the University of Florida College of Medicine — who argued that SSRIs are for most patients a safe treatment option for serious mental health disorders in pregnancy. 'Mental health disorders are no different than medical disorders,' said Roussos-Ross. 'I want to stress that treating mental illness in pregnancy is not a luxury. It's a necessity,' she said. 'We're not asking [pregnant] women to not take their anti-hypertensives and risk death to them or their baby. We're not asking women to stop their diabetes medications. We should not be withholding SSRIs as a possible treatment for women who need it.' The FDA did not respond to questions about how experts were selected for the panel. Participant Dr. Josef Witt-Doerring runs a private clinic that helps patients wean off psychiatric medication. Another panelist, Dr. Roger McFillin, is a prolific podcaster and a skeptic of germ theory, the belief — widely held as a fundamental truth in medicine since the 19th century — that infectious diseases are caused by microorganisms. Panelist Dr. David Healy, a psychiatrist from Wales, made a number of confounding and misleading statements, insisting that 'mothers who are taking SSRIs in pregnancy have a 10-fold greater risk of having a baby with fetal alcohol syndrome' (that figure describes the subject population of a single 2011 study, not the general public). Healy also stated that 'any drug that causes birth defects will cause autism spectrum disorder also,' a claim that has no basis in any scientific research. Dr. David Urato, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Mass., was the only panelist besides Roussos-Ross who cares directly for pregnant patients. He spoke forcefully on the potential harms the drugs pose to developing babies. 'Never before in human history have we chemically altered babies like this,' he said during the discussion. 'There is now more than enough evidence to support strong warnings from the FDA about how drugs disrupt fetal development and impact the moms.' Roussos-Ross argued that the increased risk of birth defects for babies exposed to SSRIs in pregnancy was statistically insignificant, and that children of mothers with untreated depression were more likely to have later behavioral problems than those of mothers who took medication for the disease. 'Having that [medication] not be available to women who need it would really be detrimental,' she said. At this, panel moderator Tracy Beth Høeg — a sports medicine doctor who is now a senior advisor for clinical sciences at the FDA — said, 'I'm going to do something unconventional. I'm sorry to play favorites, but Dr. Urato, I want you to weigh in now.' In response, Urato questioned the idea that depression can be alleviated with antidepressant medication at all. 'This idea about depression — [that it] can cause harm and therefore we treat [it] with these chemicals, and by getting the treatment we see improved outcomes — this is something we all would want. It's wishful thinking,' he said. 'But it's not actually what the data shows.' It was not clear to which data he was referring. In 2019, the most recent year for which data are available, one in every eight U.S. adults had a prescription for antidepressant medication. While the drugs don't work for all people with major depression, analyses of multiple studies have consistently found them to be significantly better than placebos at alleviating illness symptoms. The drugs have been a target of Kennedy's Make America Healthy Again movement, along with vaccines and food dyes. In his confirmation hearings and on podcast appearances, Kennedy has claimed — inaccurately — that the drugs are both linked to school shootings and harder to quit than heroin. There is no evidence for either claim. In February, President Trump placed Kennedy at the helm of the Make America Healthy Again Commission, a group tasked with, among other things, evaluating 'the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.' Healthcare professionals expressed frustration with the FDA's approach. 'There is already so much shame and stigma that surrounds these illnesses. There is also a lot of shame and stigma around taking medication during pregnancy or the postpartum period,' said Paige Bellenbaum, a perinatal mental health therapist and adjunct professor of social work at Hunter College. 'We are taking a giant step backwards in so many ways. This will reinstill the fear that was there to begin with [and] will ultimately result in the loss of life.' Alexandre Bonnin, an associate professor of pathology at USC, has studied the effects of prenatal SSRI exposure on the developing fetal brain for years. The most recent large studies in the field haven't found a statistically significant association between SSRIs and fetal harm, he said. 'Our finding, at least at the basic science level, suggests that the use of SSRIs in pregnancy can be beneficial if the mom is under major stress, anxiety or depression, because the maternal stress actually itself has many negative effects on fetal brain development,' he said.
NBC News
2 days ago
- Health
- NBC News
FDA panel promotes misinformation on antidepressants during pregnancy, psychiatrists say
A Food and Drug Administration panel on Monday discussing the use of antidepressants during pregnancy largely amounted to misinformation or facts taken out of context, according to several psychiatrists who tuned into the meeting. The panel had promised to feature diverse viewpoints about antidepressants and pregnancy. But nearly all of the 10 panelists bucked medical consensus on the drugs' safety and emphasized what they said were risks of taking the drugs while pregnant— such as causing autism, miscarriages or birth defects. In some cases, they claimed that antidepressants do not work at all and depression goes away on its own. Three of the 10 panelists were from outside the U.S. Another runs a clinic to help people taper off of psychiatric drugs. '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,' said Dr. Joseph Goldberg, a clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City. '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,' added Dr. Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia. A spokesperson for the FDA said the claim that the panel was one-sided was 'insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels.' The spokesperson added that '[FDA] Commissioner Makary has an interest in ensuring policies reflect the latest gold standard science and protect public health.' Health and Human Services Secretary Robert F. Kennedy Jr. has called for a probe into the risks of antidepressants. His 'Make America Healthy Again' report in May claimed there were 'potentially major long-term repercussions' associated with use of the drugs in childhood. The panel discussion focused on a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, which includes Lexapro, Prozac and Zoloft. The medications increase levels of serotonin, a chemical messenger in the brain that can improve mood. Psychiatrists often advise women who are taking SSRIs to continue doing so during pregnancy, since the risks of untreated depression tend to outweigh the potential risks of the medication to mother and child. However, the decision is a personal one. For ethical reasons, there are no randomized-control trials of SSRIs in pregnant women, meaning that data on potential risks mostly comes from observational studies and drug registries. Some babies born to mothers taking SSRIs may develop symptoms such as jitteriness, irritability or difficulty eating or sleeping that resolve quickly — what's known as 'neonatal adaptation syndrome.' The symptoms may be caused by medication in the baby's system or withdrawal from it. Certain studies have also found a slightly elevated risk of miscarriage associated with antidepressant use in pregnancy, though others have found no association. However, there's no convincing evidence to suggest that SSRIs are linked to autism or birth defects. 'Well-controlled studies continue to not find an association,' Payne said. Women with a history of depression are also at an increased risk of symptoms recurring during pregnancy, and depression can come with its own risks — including thoughts of self-harm or low birth weight. 'The best thing a pregnant individual could do for herself and her baby is to get the treatment that they need,' said Dr. Nancy Byatt, a perinatal psychiatrist at UMass Chan Medical School, who was not part of the panel. In addition to raising concerns about side effects, several panelists questioned the efficacy of antidepressants or suggested that data favoring the use of SSRIs was manipulated by the pharmaceutical industry. 'It's been said that SSRIs help people who are severely depressed. They don't,' said David Healy, an FDA panelist and fellow at the Royal College of Psychiatrists in the United Kingdom. Goldberg and other psychiatrists said that's simply untrue. 'You can say the moon landing was faked. Conspiracy theories abound in our world. But there is not a doubt about whether SSRIs work,' said Goldberg, a past president of the American Society of Clinical Psychopharmacology who has previously consulted for pharmaceutical companies. He said he was invited to join the FDA panel, but declined because the language of the invitation suggested it would not be a fair discussion. Healy, the panelist, also claimed that some people 'recover spontaneously' from depression. Another panelist, psychologist Roger McFillin — who hosts a podcast that challenges conventional mental health advice — suggested that depression was not an illness, but rather a product of 'women just naturally experiencing their emotions more intensely.' He added, without evidence, that many women feel coerced into taking antidepressants. Psychiatrists who weren't part of the discussion broadly decried those characterizations. 'I have never, ever, ever, ever heard of a third party pushing a prescription in pregnancy,' Goldberg said. However, he said he is aware of some obstetrician-gynecologists who aren't as familiar with SSRIs wrongly telling pregnant patients to stop taking the medications. The American College of Obstetricians and Gynecologists said in a statement on Monday that SSRIs can be lifesaving for some pregnant individuals. 'Today's FDA panel on SSRIs and pregnancy was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy,' the organization 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.' One panelist, Dr. Kay Roussos-Ross, a psychiatrist and an OB-GYN at the University of Florida College of Medicine, was the most vocal advocate for the use of SSRIs, often pushing back against others' assessments of the risks. Psychiatrists who weren't on the panel praised her science-backed commentary. '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.' Several psychiatrists who weren't on the panel said they worry the discussion could lead to regulatory action that makes it harder to access SSRIs. For example, panelist Dr. Adam Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Massachusetts, called for stronger warnings on SSRI labels. 'I am just very nervous that some of the discourse around the risks of antidepressants could lead to even more barriers for people seeking care,' said Dr. Lindsay Lebin, an assistant professor of psychiatry at the University of Colorado Anschutz Medical Campus, who was not part of the FDA discussion.
New York Times
2 days ago
- Health
- New York Times
F.D.A. Panel Debates ‘Black Box' Warning for Antidepressants in Pregnancy
Over nearly four decades since Prozac was approved for the treatment of depression, waves of concern about the effects of antidepressants during pregnancy have resulted in a practical consensus: Though use of the drugs may be associated with a slight rise in the odds of birth defects, the risk of leaving a mother's depression untreated is often greater. But a high-level shift is taking place within the Department of Health and Human Services under Secretary Robert F. Kennedy Jr., who has made reducing the prescription of psychotropic drugs a policy priority. Among the select group of experts convened by the Food and Drug Administration on Monday to discuss the safety of antidepressants during pregnancy, around half said that women should receive a more clear and forceful warning about potential risks to the fetus. Andrew Nixon, an H.H.S. spokesman, said the agency would not comment on whether there were plans to require a so-called black box warning about the use of selective serotonin reuptake inhibitors, or S.S.R.I.s, in pregnancy. In his introductory remarks, F.D.A. commissioner Dr. Marty Makary said that 'some women are not aware' of the risks of taking antidepressants in pregnancy, suggesting openness to the idea. Around 5 percent of pregnant American women take antidepressants, he said. 'Serotonin might play a crucial role in the development of organs of a baby in utero,' Dr. Makary said. Want all of The Times? Subscribe.
Axios
6 days ago
- Health
- Axios
Brigham, IBM's AI tool could help warn Boston's hottest neighborhoods of heat waves
While a heat wave smothers Boston, researchers are developing a tool to warn people of heat emergencies and the risks they face sooner. Why it matters: Some Boston neighborhoods — known as "urban heat islands" — are scorching by the time the sensor at Logan Airport notifies forecasters and city leaders of a heat emergency. Driving the news: A team at Brigham and Women's Hospital and IBM is building an AI-driven tool that would identify high temperatures in urban heat islands sooner and offer suggestions on how to cool down. That could mean going to a cooling center or an air-conditioned library building nearby, says Paul Biddinger, chief preparedness and continuity officer at Mass General Brigham, who is leading the project. The team envisions the tool warning community health center patients of heat emergencies, especially those who may be at high risk, without compromising sensitive health data. What they're saying: "People don't know when they're at higher risk often," Biddinger tells Axios. Take water pills for heart failure? Got chronic lung or kidney conditions? You're at higher risk, Biddinger wrote Tuesday. Take SSRIs for depression? You, too. Zoom out: The coastal Northeast is heating faster than most regions in North America, per UMass research. But many homes lack updated infrastructure or were designed to trap heat to keep residents warm in the winter. More people will become vulnerable to extreme heat risks as climate change worsens, doctors and researchers say. Threat level: The state estimated last year that at least 30 people have died from extreme heat here in the past decade, and that doesn't take into account the thousands who have been hospitalized since 2000. Pockets of Dorchester, South Boston, Chinatown and Roxbury see higher temperatures than neighboring areas. Yes, but: The AI tool is still in development, Biddinger says. The team plans to launch a prototype in multiple languages before next summer and a final version by 2027. Reality check: In the meantime, Bostonians will have to take the forecast with a grain of salt (or round up the temperature), depending on where they live.
New York Times
16-07-2025
- Health
- New York Times
How Exercise Fights Anxiety and Depression
When it comes to mental health, most treatments for conditions like depression or anxiety come with caveats. Medications work for some symptoms, but can exacerbate others. Cognitive behavioral therapy is effective for many patients, but not all. But there's one strategy that seems to work for most people and almost all experts endorse, and that's regular exercise. Decades of research have established that exercise has a positive effect on mental health. In studies of patients with mild to moderate depression, for example, a wide range of exercise regimens has been shown to be as effective as medications like SSRIs (though the best results generally involve a combination of the two). Moving regularly can improve sleep and reduce stress. While there's good evidence for the mental health benefits of exercising for about 45 minutes, three to five times per week, even just a few minutes of walking around the block can have positive effects. 'Is this walk going to do anything?' said Jennifer Heisz, an associate professor at McMaster University in Canada and the author of 'Move the Body, Heal the Mind.' 'Yes! The answer is yes. It'll do way more than you think.' Why is exercise good for mental health? It's hard to find a brain process that doesn't improve with regular movement. Exercise boosts blood flow, decreases inflammation and improves brain plasticity. It also triggers the release of many mood-boosting chemicals, including beta-endorphins and cannabinoids (which both play a role in the 'runner's high' feeling), norepinephrine, dopamine and serotonin. Want all of The Times? Subscribe.
