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The Hill
28-07-2025
- Health
- The Hill
FDA considers warning about antidepressants during pregnancy
(NewsNation) — An advisory panel has urged the Federal Drug Administration to warn against the use of antidepressants in pregnant women. The medical consensus thus far has been that antidepressants are safe, and the risks of untreated depression outweigh the slight risks to pregnancy. However, some panelists last week said the drugs present risks of autism, miscarriage and birth defects. They flagged the possible negative interactions between the drug and fetal development. 'SSRIs may be unique because serotonin may have an interaction with the physiology of a woman and a woman who is pregnant,' said FDA Commissioner Marty Makary. 'Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain and even the gut.' Selective Serotonin Reuptake Inhibitors, or SSRIs, are a class of medications used to treat depression by increasing serotonin levels in the brain. Some panelists proposed adding warning labels to medication bottles about adverse maternal and fetal risks during pregnancy. Are antidepressants dangerous for pregnant women? 'There is generally no need to taper off medications during pregnancy, because antidepressants have not been known to cause birth defects,' according to Johns Hopkins Medicine. 'In fact, untreated mental illness itself poses risks to a developing fetus.' While most experts in the medical field have found SSRIs to be largely safe for pregnant women and their unborn babies, about 30% of babies whose mothers take them will experience neonatal adaptation syndrome. The condition can cause increased jitteriness, irritability and difficulty breathing, according to Johns Hopkins, but doctors aren't sure whether this is due to the baby's withdrawal from the SSRI after birth or exposure to the drug before birth. Some organizations have criticized the panel's recommendations as misinformed and have said it disregarded risks associated with untreated depression in mothers. 'For pregnant people who need SSRIs, they are life-changing and lifesaving. Mental health conditions are already the most frequent cause of pregnancy-related death,' said Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, in a statement. 'Unfortunately, the many outlandish and unfounded claims made by the panelists regarding SSRIs will only serve to incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need.'
Yahoo
19-07-2025
- Health
- Yahoo
Over 67,000 Cases of This Popular Deodorant Have Been Recalled—Here's What to Know
Over 67,000 Cases of This Popular Deodorant Have Been Recalled—Here's What to Know originally appeared on Parade. Over 67,000 cases of a popular deodorant have been recalled. In an enforcement report published by the Federal Drug Administration (FDA), the recall was initiated by the deodorant's company on July 10, 2025. It is still ongoing. Created by A.P. Deauville, the recall involves the personal care company's Power Stick for Her Roll-On Antiperspirant Deodorant in "Power Fresh," Power Stick Invisible Protection Roll-On Antiperspirant Deodorant in "Spring Fresh" and Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant. 🎬 SIGN UP for Parade's Daily newsletter to get the latest pop culture news & celebrity interviews delivered right to your inbox 🎬 The recall was initiated by A.P. Deauville themselves, citing cGMP deviations. This means it was related to the FDA's Current Good Manufacturing Practice regulations. cGMP deviations indicate that procedures and standards outlined in the Current Good Manufacturing Practice regulations have not been followed. This can happen at any stage of the production process. For this particular instance, the manufacturing issue has not be disclosed.21,265 cases cases of the Power Fresh scent are currently being recalled, including lot numbers 032026B011, 032226B031, 051626C241, 061526C882, 071226D371, 071226D381, 082526E341 and 082826E402. For the Spring Fresh scent, 22,482 cases are being recalled, including lot numbers 031726A991, 041226B561, 062026C901, 062026C911, 071026D351, 071026D361, 071326D391 and 111626G231. For the original version of the deodorant, 23,467 cases are being recalled, including lot numbers 101225D781, 032926B281, 032826B221, 041126B531, 062226D011, 070626D301, 070626D333, 111026G051, 111326G091 and 111626G221. The implicated cases of the Power Stick Deodorant were shipped nationwide, according to the FDA report. The deodorant is sold at Walmart, Dollar Tree and Amazon. A.P. Deauville is based in Easton, Pennsylvania. The men and women's personal care company also makes shampoos, conditioners, lotion, body washes and facial wipes, according to its website. At this time, no press release has been released involving the 67,000 Cases of This Popular Deodorant Have Been Recalled—Here's What to Know first appeared on Parade on Jul 17, 2025 This story was originally reported by Parade on Jul 17, 2025, where it first appeared. Solve the daily Crossword
San Francisco Chronicle
17-06-2025
- Health
- San Francisco Chronicle
Texas is leading psychedelic research for treating addiction, mental illness. Where is California?
In recent years, researchers have expressed renewed optimism that psychedelics can be used in therapeutic settings to help treat addiction and mental illness, intertwined crises that have devastated Californians. Yet the Golden State is falling behind Republican-led states like Texas and Indiana in expanding research on these promising therapies. Texas earlier this month agreed to invest $50 million in public funding to research the therapeutic potential of ibogaine, a powerful psychedelic that has shown promise in treating opioid addiction, depression and anxiety. The move by Texas lawmakers was described as one of the largest public investments in psychedelic medicine to date. At his signing ceremony, Texas Gov. Greg Abbott proclaimed that 'Texas is now leading the way in the United States for the evaluation of ibogaine as a potential medication that can help improve the lives of so many Americans." Last year, Indiana Gov. Eric Holcomb signed a law to create a new research fund for therapy using psilocybin, a naturally occurring psychedelic compound found in 'magic mushrooms.' Although the federal government has not approved ibogaine, or most psychedelics, for medical use, there's growing interest among researchers and veteran organizations to explore the therapeutic benefits of drugs like ibogaine, MDMA, LSD, ketamine and psilocybin. Some California organizations have made considerable strides, though there have been roadblocks. San Jose-based Lykos Therapeutics last year became the first company to get a psychedelic compound through the Federal Drug Administration's extensive drug review process for an MDMA-assisted therapy for PTSD but the agency instructed the company to conduct more clinical trials before potential approval. For years, people experiencing addiction and mental illness, including a growing number of veterans and first responders, have quietly traveled to psychedelic-assisted treatment clinics in Mexico. Early research has produced some encouraging results for using these substances to treat addiction and mental illness, including depression, anxiety and post-traumatic stress disorder. Most prominent California universities employ researchers participating in therapeutic psychedelic clinical trials, though they're funded by federal grants, philanthropic donors or private pharmaceutical companies. A 2024 study from Stanford Medicine, for instance, found that ibogaine, when administered safely, improved emotional processing and cognitive functioning in veterans with traumatic brain injuries. The new spotlight on the therapeutic potential of psychedelics comes amid national opioid addiction and mental health crises, where for decades research has lagged. California has not made any public investments to date in researching psychedelic medicine, though there have been several failed attempts in recent years. 'There is growing awareness and support. It just keeps hitting different kinds of walls,' said State Senator Scott Wiener, D- San Francisco, adding that 'California is falling behind.' Gov. Gavin Newsom in 2023 vetoed a bill authored by Wiener to decriminalize the use and possession of certain psychedelics. Newsom called psychedelic medicine 'an exciting frontier' and said that California would be 'on the front edge of leading it,' but urged lawmakers to bring the legislation back the following session with more of a therapeutic focus. Wiener followed Newsom's request and introduced a bill last year with therapeutic guidelines, but it failed in committee. Also in 2023, a Los Angeles-based physician filed paperwork for a $5 billion ballot initiative to create a new state agency for studying the effects of psychedelic-assisted therapy, but it was later withdrawn. Additionally, two other state senators, Josh Becker, D-Menlo Park, and Brian Jones, R-San Diego, sponsored legislation to create a pilot program for veterans and former first responders to access psychedelic treatment for mental health conditions. The measure failed to make it out of the legislature two years in a row. 'I don't know what's going on in California to tell you the truth,' Jones said. 'Senator Becker and I are committed to trying again. It's just a question of how far other states get ahead of us now.' The Texas initiative focuses specifically on research involving ibogaine, a psychedelic compound originating from an African root. Ibogaine was used for centuries in religious ceremonies, but more recently has attracted attention for its antidepressant properties and its apparent ability to reduce opioid cravings and withdrawal. Under the Texas law, the state will invest $50 million in state funds to establish a public-private partnership with a $50 million matching contribution from a drug developer to run FDA-approved clinical trials with ibogaine. The goal is to study its ability to treat opioid use disorder and any co-occurring mental health conditions. The legislation guarantees Texas maintains authority over the research and development and that the state receives at least 20% of profits from any ibogaine pharmaceutical resulting from the trials. David Olson, director of the UC Davis Institute for Psychedelics and Neurotherapeutics, said the investment in Texas was 'very encouraging for the field of psychedelic medicine' but questioned the decision by Texas lawmakers to go all in on ibogaine. 'I would have preferred to see legislation where a variety of different types of substances were considered and then they can move forward with whatever was deemed most appropriate,' Olson said. 'At this moment, there are still so many unanswered questions and we need a lot of basic science across the board.' Although ibogaine has shown some promising results in treating opioid addiction and mental illness, it has also caused heart damage and deaths to several patients. The drug is known to inhibit certain potassium channels, which can lead to cardiac arrhythmias, but ibogaine proponents argue that it can be mitigated through regular supervision, magnesium administration and cardiac monitoring. Researchers believe other psychedelics, notably psilocybin, have shown more efficacy and are closer to gaining approval by the FDA. 'Psychedelics have inherent potential to be of great value to people for whom standard treatments often prove ineffectual,' said Charles Grob, a professor of psychiatry and pediatrics at the UCLA School of Medicine. 'But investigators have to do their due diligence to optimize safety parameters.'
CNBC
29-05-2025
- Business
- CNBC
This start-up is lowering the chances of passing on life-threatening diseases to your children—but it will cost you
Biotech start-up Orchid is one of the few companies offering in-vitro fertilisation (IVF) patients the option to screen their embryos for severe genetic diseases before their pregnancy begins. "This technology is going to totally reshape how people have children," Orchid's CEO Noor Siddiqui told CNBC's The Edge in an interview. "I think it's going to become an option that more and more people will choose because there's just the opportunity to avoid a lot of catastrophic outcomes, and they don't want to roll the dice on their child's health," Siddiqui added. During IVF, a woman takes fertility hormones to suppress her natural menstrual cycle and increase the number of eggs in her ovaries. Once her eggs are collected, they are mixed with the sperm and fertilized in a lab. The viable embryos are then transferred to the uterus. Siddiqui says that Orchid has developed a new technology that sequences 99% of an embryo's entire genome before implantation in the womb and screens for over 1,200 monogenic conditions, as well as some polygenic diseases. "When you have an embryo sample, you have about 125 cells on day five, and the embryologist at the IVF lab sends us about five of those cells, and in those five cells, you only have about 10,000 times less than the amount of DNA that you would have in a blood or saliva sample. So, what we had to invent is a new amplification protocol, as well as a new computational pipeline," Siddiqui said. The embryo screening process takes between two and three weeks, after which patients receive a whole genome embryo report. Orchid's counselors go through the report and help patients decide which embryo to move forward. Despite having been cleared by the Federal Drug Administration as a laboratory developed test (LDT) and backed by geneticists like George Church and Carlos Bustamante, Orchid's procedure has failed to convince some. "These tests, in general, cost money, often not covered by insurance. And so increasingly, breast cancer, for instance, is becoming more a disease of the poor because people can afford to undergo IVF and screen out breast cancer mutations when they've had a family history of breast cancer. I think that raises a problem ethically," bioethicist and Columbia University professor Robert Klitzman told The Edge in an interview. Orchid currently charges $2,500 per embryo screening. That's in addition to the IVF process which, according to the U.S. Department of Health and Human Services, ranges from $15,000 to $20,000 for a single cycle and sometimes requires several attempts. To mitigate the costs, the company has a philanthropic program that patients on low incomes can apply for. Orchid's technology is now available nationwide in the U.S. except in New York state, where Orchid had applied for a license to operate at the time of the interview. Learn more about Orchid's technology by clicking the video above. IVF was conceived as a reproductive method for people with infertility issues, but over the past decade, other patient groups have turned to it to prevent passing on genetic conditions to their child.
Yahoo
26-05-2025
- Health
- Yahoo
RFK Jr.'s FDA Head Wants Diabetics to Get Cooking Classes Over Insulin
The head of the Federal Drug Administration says diabetics should get a recipe book instead of insulin. 'Maybe we need to treat more diabetes with cooking classes, not just throwing insulin at people,' FDA Commissioner Marty Makary said on Fox News' Sunday Futures. 'You know, scientists have been waving the flag for years, saying you've got to look at this body of scientific data, and the modern medical establishment really has been disconnected.' Repeated studies over more than a century have shown insulin is a safe and effective treatment for diabetes, though medical professionals also recommend controlling blood sugar through diet, according to the American Diabetes Association. Makary further used his Sunday appearance on Fox to promote a new report from the Trump administration's Make America Healthy Again Commission, released earlier this week, which called for federal agencies to urgently examine a variety of perceived threats to children's health. 'This report is a fresh new approach that really calls for a transformation of our healthcare system from a reactionary system to a proactive system,' Makary said. 'I could not be more excited about it.' These include vaccines and exposure to harmful chemicals, all longstanding bugbears for Health and Human Services (HHS) Secretary Robert F. Kennedy. Kennedy has come under repeated fire for misrepresenting or pushing bogus claims about the role of those factors in various adverse health conditions. Kennedy has courted controversy in particular for his long-running attempts to link vaccines to autism, which he has ordered HHS to investigate. The Health Secretary has also pressured the Centers for Disease Control to stop recommending fluoride in drinking water because of baseless claims the chemical may be connected to cancer and neurological impairments. In addition, Kennedy has also called on the FDA to begin phasing out synthetic dyes used to enhance color in foods.
