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FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say

FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say

Yahoo2 days ago
A Food and Drug Administration panel discussing the use of antidepressants during pregnancy Monday largely amounted to misinformation or facts taken out of context, according to several psychiatrists who tuned in to 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 don't work at all and that depression goes away on its own.
Three of the 10 panelists were from outside the United States. 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.
Dr. Jennifer Payne, director of the Reproductive Psychiatry Research Program 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.'
A spokesperson for the FDA said in a statement that 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 Martin 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 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 babies' systems 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 histories 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 wasn't 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 wouldn't 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 wasn't 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 who have wrongly told pregnant patients to stop taking the medications.
The American College of Obstetricians and Gynecologists said in a statement Monday that SSRIs can be lifesaving for some pregnant people.
'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,' 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.'
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 using 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 that the discussion could lead to regulatory action that makes it harder to access SSRIs. For example, one 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 wasn't part of the FDA discussion.
This article was originally published on NBCNews.com
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Black box warning on menopause hormone therapies should be removed, experts say
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All menopause treatments containing the hormone estrogen are mandated by the US Food and Drug Administration to carry a black box warning on the label, stating that the treatments could increase the risk of strokes, blood clots, dementia and breast cancer. Now, that advisory may be going away. Last week, a panel of experts convened by the FDA urged the federal agency to remove the cautionary language on at least some forms of hormone therapy. I wanted to understand more about why these warnings were first added and the arguments for and against removing them now. What are hormone therapies used for, and what are the different forms of treatment? What is the history behind adding black box warnings, and why are some experts pushing to remove them? What should women know about managing menopause symptoms? I turned to CNN wellness expert Dr. Leana Wen to answer these questions. Wen is an emergency physician and adjunct associate professor at George Washington University. 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Black box warning on menopause hormone therapies should be removed, experts say
Black box warning on menopause hormone therapies should be removed, experts say

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Black box warning on menopause hormone therapies should be removed, experts say

Women's health Federal agenciesFacebookTweetLink Follow All menopause treatments containing the hormone estrogen are mandated by the US Food and Drug Administration to carry a black box warning on the label, stating that the treatments could increase the risk of strokes, blood clots, dementia and breast cancer. Now, that advisory may be going away. Last week, a panel of experts convened by the FDA urged the federal agency to remove the cautionary language on at least some forms of hormone therapy. I wanted to understand more about why these warnings were first added and the arguments for and against removing them now. What are hormone therapies used for, and what are the different forms of treatment? What is the history behind adding black box warnings, and why are some experts pushing to remove them? What should women know about managing menopause symptoms? I turned to CNN wellness expert Dr. Leana Wen to answer these questions. Wen is an emergency physician and adjunct associate professor at George Washington University. She previously was Baltimore's health commissioner. CNN: When does menopause occur, and what kinds of symptoms do women experience during menopause? Dr. Leana Wen: Menopause is the stage in a woman's life when her menstrual periods permanently stop. It marks the end of fertility and is accompanied by a decline in reproductive hormones such as estrogen and progesterone. In the US, most women begin the menopause transition between ages 45 and 55, and the average age is 52. The definition of menopause is a full year without having a period. Except in situations where menopause is induced by surgery (for example, removal of ovaries) or specific medical conditions, this period is generally preceded by a stage called perimenopause, when women may have irregular periods and start experiencing menopause symptoms. Symptoms associated with menopause can include hot flashes and night sweats. Hot flashes are sudden sensations of heat, skin flushing and sweating that can significantly disrupt daily activities. About one-third of women have more than 10 hot flashes per day. When they occur at night, they can disrupt sleep and increase fatigue and irritability during the day. Menopausal declines in estrogen also may cause vaginal dryness, decreased libido and discomfort during intercourse. Some women experience other symptoms such as mood changes, anxiety, difficulty concentrating, dry skin and weight gain. Moreover, while this is not a symptom of menopause per se, the risk of developing chronic conditions such as cardiovascular disease and osteoporosis increases significantly after menopause. This rise in risk is thought to be linked to the decline in estrogen levels, as estrogen has a protective effect on maintaining healthy blood vessels and supporting bone density. CNN: What are hormone therapies used for? What are the different forms of treatment? Wen: Hormone therapies are prescription drugs that are used to treat menopause symptoms. They replace the hormones that decline during menopause. It's important to differentiate between two types of hormone therapy. The first is systemic therapy in which hormones are given in a way that is absorbed into the bloodstream. That could be through taking pills or using patches, sprays or gels. Systemic therapy is used to treat symptoms that affect the entire body, such as flashes and night sweats. The second type is low-dose vaginal estrogen therapy. This is a cream or suppository administered into the vagina to treat vaginal dryness and reduce tissue thinning. Unlike systemic therapy, this type of therapy works locally; its purpose is not to raise hormone levels throughout the body. CNN: What is the history behind adding black box warnings, and why are some experts pushing to remove them? Wen: For decades, hormone therapy was considered the standard of care for menopause-related symptoms. Then, in the early 2000s, a landmark study called the Women's Health Initiative was published that suggested hormone therapy increased the risk of breast cancer, heart disease and stroke. It concluded that the benefits of this therapy did not outweigh these risks, leading to the FDA adding the black box warning in 2003. Many researchers have since examined the methodological problems of the study. One significant issue was that the average age of participants was 63. The women studied were mostly postmenopausal, so the question answered was regarding the risks and benefits to postmenopausal women, not menopausal women. Last year, scientists — including some of the original researchers of the Women's Health Initiative — published an updated analysis in the journal JAMA. They concluded that, in fact, hormone treatment with a combination of estrogen and progesterone is safe and effective for treating hot flashes and other systemic symptoms if started before age 60 or within 10 years of starting menopause and if the woman does not have specific contraindications — for instance, an estrogen-sensitive breast cancer. This updated analysis is one reason cited by many advocates to remove the warning. Another major reason is that the black box warning is currently on all types of hormone treatments, including vaginal therapies that deliver far lower doses and do not have the systemic effect of, say, an estrogen-containing pill. Advocates argue that putting all forms of hormone therapy under the same warning misrepresents risk and makes it harder for women to receive relief from troublesome symptoms. Women are still able to access the therapies despite the warning, but some may be more hesitant to use them after seeing the warnings. CNN: What are other arguments for and against this change? Wen: In his opening argument, FDA Commissioner Dr. Marty Makary remarked that systemic hormone therapy, when started within 10 years of the onset of menopause, can actually reduce cardiovascular disease. This finding is suggested by some recent studies, which also show a benefit for bone health. Not everyone agrees that hormone therapy should be taken for preventive purposes. There is also some controversy about process; specifically, the panelists who spoke at last week's FDA meeting were all selected by Makary and all favored hormone therapy. Some have said they would appreciate more balance by hearing from experts who have more nuanced views. In addition, there was no presentation by internal FDA scientists, who, in the past, have given their own analysis during these types of meetings. CNN: While the FDA is considering changing the warning label, what is your advice for women about managing menopause symptoms? Wen: The most important thing is that women who are experiencing significant symptoms during menopause don't need to suffer in silence. Effective treatments exist. Women should speak with their physicians about lifestyle measures that can help as well as hormonal and nonhormonal prescription therapies. They should also speak with their providers about preventive care to improve heart health and prevent bone loss. Those who want additional resources should look to the Menopause Society, which also has a searchable database of clinicians who are certified menopause practitioners and trained to guide women through this transition.

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