Latest news with #FDAMartyMakary
The Guardian
3 days ago
- Health
- The Guardian
I'm a perinatal psychiatrist. The US is promoting misinformation on SSRIs and pregnancy
Late last month, the FDA advisory panel – on the heels of the president's 'make America healthy again' executive order scrutinizing psychotropic medications – raised debate around the safety of selective serotonin reuptake inhibitors (SSRIs) in pregnancy. Commonly called antidepressants, these medications are used to treat a range of disorders, and earlier this year a consortium of major mental health organizations pushed back on the administration's stance. As a perinatal psychiatrist who sees pregnant and postpartum people struggling with conditions such as depression and anxiety every week, I'm deeply concerned that this public discussion – chaired by the controversial FDA commissioner Marty Makary – shared significant misinformation about mental illness and the treatment modalities (with overly simplified statements denouncing 'chemicals' during pregnancy). Here in Washington DC, I recently examined a pregnant woman struggling with severe depression and anxiety. As she was nervously mulling treatment options we had discussed, she asked me questions about starting medication to treat her condition: will this affect my child's development? How long will the medication stay in my child's bloodstream? How much of the medication will go into my breast milk? Do I have to stay on it for ever? These questions are part of everyday practice for those who care for individuals making decisions about treating their mental health challenges in the course of pregnancy. And answering them clearly is critical for people already dealing with some of the most difficult and vulnerable moments of their lives. But giving established guidance becomes difficult at a time when the authorities themselves are platforming misinformation under the guise of scientific inquiry. There isn't enough space here to deconstruct all of the falsehoods shared by some of the FDA panelists, with often meandering anecdotes that did not address the core issue being discussed. The panelists overstated risks, which may deter treatment, despite robust data supporting the safety of use of SSRIs when clinically indicated. As the adage attributed to W Edwards Deming goes: 'In God we trust; all others, bring data.' Here's the data: we know that severe maternal mental health challenges occur during pregnancy and the postpartum period. And according to a recent national study, there have been large declines in mental health among pregnant women – one in five pregnant women struggles with conditions such as anxiety and depression during their pregnancy. Three in four pregnant persons are untreated. That's more than 500,000 people every year who experience significant mental health issues before, during or after their pregnancies. There are also real harms of untreated perinatal depression and anxiety – such as preterm birth, bonding difficulties, and even maternal death by suicide or overdose. The low, manageable neonatal risks generally support initiating and continuing SSRIs when they're clinically needed. These women need and deserve evidence-based care. And as for pregnant people who do take SSRIs, large reviews, called meta-analyses, find no overall rise in major birth defects from taking SSRIs during pregnancy, and occasional small links to heart problems with certain drugs disappear in larger studies. Some newborns exposed late in pregnancy may have an issue called neonatal adaptation syndrome – mild, brief withdrawal-like symptoms which include jitteriness, poor feeding and affect the baby's breathing – but this almost always clears up quickly with routine care in the first week. There is also an inherent problem in the way the FDA panelists spoke about the issue: one that minimized the health of the mother and focused solely on the baby. I am the first person to say there is a dearth of science when it comes to maternal mental healthcare. We need more research, and it is unfair that so many are left scrambling for help outside of our health system. But we should be seriously weighing the risk of not treating these conditions because mental illness is real and has significant impacts on the wellbeing of the pregnant person and baby. SSRIs are not new drugs – they've been on the market for more than 30 years, and if there is a widespread epidemic of the harms that the FDA panel claimed, it is not substantiated in the data. So let's not apply an inconsistent standard towards SSRIs in pregnancy. Their comments that we need more data is the last slide or nearly every scientific discussion – of course, we need more robust data. That shouldn't seed unnecessary doubt and leave patients and their doctors in a limbo on how best to treat these conditions. We need the right treatment, for the right patient, at the right time. In this moment when trust in government institutions is at a low, sowing further doubt is the last thing my patients deserve. The American public needs to know they are getting the highest quality guidance; in the absence of that, lives are at risk. As we've seen in the case of vaccines, official federal guidance has been rapidly changing and is often out of alignment with the best science available. Professional medical societies are currently filling the void where government guidance falls short. If this panel on SSRIs is a harbinger of what's to come, this might become the case for SSRIs in pregnancy. The American Psychiatric Association and American College of Obstetrics and Gynecology have expert guidance on treatment, including psychotropic medications. As for my patient, we evaluated the data – doctor and patient – and together she made an informed decision weighing the risks and benefits to start an SSRI along with therapy. Her mood and anxiety improved, and she had a safe delivery. Both mother and baby are thriving. Dr Sunny Patel is a psychiatrist at Georgetown's Thrive Center for Children, Families, and Communities. He recently served as senior adviser at the Substance Abuse and Mental Health Services Administration
Yahoo
24-07-2025
- Health
- Yahoo
Do fluoride supplements harm children? FDA panel discussion turns into heated debate
A meeting Wednesday at the Food and Drug Administration about fluoride supplements became, at one point, a contentious back-and-forth over whether the ingestible tablets harm children's microbiomes or play a vital role in helping protect them from tooth decay. Pediatric dentists consider the chewable tablets, available only by prescription, as particularly important for families who live in areas without fluoride in drinking water, who don't have dental insurance or who can't afford regular visits to dentists. Under Commissioner Marty Makary, however, the FDA has been taking steps to remove fluoride supplements from the market. A final decision isn't expected until October, although advocates and critics at the meeting didn't agree on basic scientific methods or even responsible dental practices. During the public meeting held in Silver Spring, Maryland, dental experts outlined the careful balance of getting the right amount of fluoride to their patients. Too little can result in weakened tooth enamel, said Dr. James Bekker, a member of the Utah Dental Association. Too much can lead to fluorosis, a condition that leaves white or brown spots on the teeth. 'There are areas where we have community water fluoridation. We don't need supplements in those areas,' said Bekker, who was invited to speak at Wednesday's meeting. 'But there are many areas of our country where we either don't have community water fluoridation or we don't have naturally occurring fluoride. In those places, supplements are the key to achieving that balance.' A panelist, Dr. Bill Osmunson, a retired dentist who now works for the Fluoride Action Network, an anti-fluoride group, peppered Bekker about how he determines whether a child needs fluoride supplements. 'You ask where they live?' Osmunson asked. 'You ask where they go to school?' Bekker explained how he does comprehensive assessments of his young patients, including reviewing dietary issues and whether they use other supplements, before he prescribes the fluoride tablets or drops. 'Really, you ask all those questions?' Osmunson said. 'You bet,' Bekker said. Osmunson's 'inquisition of Dr. Bekker was a tactic to attempt to make him look incompetent,' said Dr. Johnny Johnson, president of the American Fluoridation Society. 'That type of exchange is meant as a popularity contest.' Johnson spoke in favor of the supplement during a public comment session. Osmunson and other critics relied on data that didn't necessarily prove their criticism of the products. For example, Makary, the FDA commissioner, has said ingested fluoride alters the gut microbiome. His assertion appears to hinge on a 2023 review of research by scientists in Ireland. That analysis noted that animal studies suggested that ingesting fluoride affected the microbiome but that none of the studies examined fluoride and the human microbiome. The researchers concluded that any possible effect of fluoride on the microbiome is 'still in its early days, and studies investigating the impact of fluoride on the human microbiome have only begun to appear in the literature.' One of the authors of that study also spoke at Wednesday's meeting. 'Fluoride consumption at levels which we consider good for maintaining good oral health probably have limited impact on the oral and gut microbiomes,' said Gary Moran of Trinity College Dublin in Ireland. But, he added, 'we certainly need more studies.' There was no vote for or against fluoride supplements. Dr. David Krol, a representative of the American Academy of Pediatrics, spoke in favor of fluoride supplements as one of many tools physicians need to ensure their patients' teeth are as strong as possible. 'Fluoride supplementation, as well as conversations about diet and conversations about hygiene, are the kinds of things that take place between pediatricians and patients,' Krol said. 'We have to have that opportunity to continue those conversations and have those multifactorial tools to address this disease.' Even though Medicaid covers oral health for children, fewer than half went to the dentist at least once a year. Cavities that erupt in those kids' mouths get worse if they're left untreated, and they can cause widespread damage. The decay 'eats away at the bone' around the tooth and sometimes gets into the bloodstream, said Dr. Steven Levy, a professor of preventive and community dentistry at the University of Iowa. 'This is more than just a garden-variety, middle-class person's experience with a cavity,' he said. Major public health groups, including the American Academy of Pediatrics and the U.S. Preventive Services Task Force, recommend prescribing supplements for children starting at 6 months if the water supply isn't fluoridated. Fluoride supplements are often given to kids from age 5 until they have their permanent teeth, around age 13 or 14, Bekker said in an interview before the meeting. Babies get drops until they're old enough to chew tablets. They're generally inexpensive. Over-the-counter vitamins and supplements don't contain fluoride. Fluoride is available over the counter only in toothpaste and mouthwashes. Makary also objects to the fluoride supplements because they aren't approved by the FDA. Because the supplements had been in use for decades before Congress mandated that drug manufacturers show that their products were not only safe but also effective, they were never required to go through the approval process. For almost as long as the supplements have been prescribed, critics have been concerned about the lack of rigorous data showing their potential health effects and how they protect kids' teeth. 'I think we really need to understand the benefits,' said Linda Birnbaum, a toxicologist and former director of the National Institute of Environmental Health Sciences and the National Toxicology Program. Birnbaum also spoke during the FDA meeting. Dr. Brett Kessler of the American Dental Association acknowledged that prescription fluoride supplements should be administered only after a 'thoughtful decision' based on conversations between physicians and families. 'I'm hoping we can all take a breath, filter out all the noise and not give in to the anti-fluoride hysteria,' he said during the meeting. This article was originally published on Solve the daily Crossword
CNET
14-07-2025
- Health
- CNET
The FDA Just Approved a New Blue Food Dye. Is It an Allergen?
This year, food dyes are being put under a microscope. Following the US Food and Drug Administration's ban on Red Dye No. 3 in January, the administration has since approved three natural food dyes in its stead. Now, in addition to the FDA and Department of Health and Human Services asking food manufacturers to phase out all petroleum-based synthetic dyes from the US food supply, the FDA is asking these companies to fast-track getting rid of Red No. 3 before the 2027 deadline. To help this along, the administration just approved a new blue food dye. As the fourth color additive from natural sources approved by the FDA this year, gardenia (genipin) blue has been granted permission to be used in various foods. According to the administration, this blue dye comes from the fruit of the gardenia, a flowering evergreen. It can be used in hard and soft candy, sports drinks, ready-to-drink teas, flavored or enhanced noncarbonated water and fruit drinks and ades. "This expedited timeline underscored our serious intent to transition away from petroleum-based synthetic dyes in the food supply," said FDA Commissioner Marty Makary in a news release. "Now, by expanding the palette of available colors derived from natural sources, food manufacturers have a variety of options available that will make it easier to end their use of petroleum-based dyes." Gardenia (genipin) blue joins the red algae-based galdieria extract blue, butterfly pea flower extract and the white color calcium phosphate as 2025's new and approved natural food color additives. MichelleIs gardenia (genipin) blue an allergen? The FDA approved the use of gardenia (genipin) blue from a petition by the Gardenia Blue Interest Group. According to the FDA's order, gardenia (genipin) blue is a dark purple or blue liquid made from the mature fruit of the Gardenia jasminoides Ellis plant with soy protein hydrolysate. Now, you may be thinking: Isn't soy an allergen? According to the GBIG, the soy protein allergens aren't expected to be detected in the final color additive because "unreacted protein hydrolysate is removed during manufacturing." Because no soy protein allergens will be in the final product, the GBIG is asking to be exempt from food allergen labeling. The FDA is currently reviewing this petition.
