Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support
The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established.
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Yahoo
24 minutes ago
- Yahoo
Texas A&M mascot Reveille has eye removed after glaucoma diagnosis
Texas A&M announced Wednesday that Reveille X, the school's mascot, had to have an eye removed during surgery after she was diagnosed with glaucoma. The collie has served as A&M's mascot since April 30, 2021, when Reveille IX retired. Reveille is a central part of gameday activities at Texas A&M and runs out on the field ahead of home games before taking her normal spot on the sidelines. 'Under the watchful eye of her Mascot Corporals, it came to our attention that Miss Rev has been experiencing some discomfort and cloudiness in her right eye,' A&M president Mark Welsh said in a statement. Sadly, the issue has progressed and during a recent check-up, she was diagnosed with glaucoma. At the recommendation of our world-class veterinarians at the Texas A&M Veterinary Medical Teaching Hospital, Miss Rev underwent surgery earlier [Wednesday] to relieve any discomfort. During surgery, the veterinary team discovered signs of abnormal tissue, and out of an abundance of caution, removed her eye. The tissue was sent to an ocular pathologist for evaluation, which is standard practice.' Welsh said in his statement that Reveille would not make any public appearances while she recovers from her surgery, but that the school 'can expect Miss Rev to be back to enjoying all her favorite activities — cruising on Rev Force One, attending classes, cheering on the Aggies, and keeping our campus squirrels in line - this fall.' The first Reveille was adopted by A&M students in the 1930s and the mascot is officially listed as the highest-ranking member of school's Corps of Cadets. Members of the corps take care of Reveille and she goes everywhere with her caretakers and she's the only non-service dog allowed on campus building. According to Texas A&M tradition, if Reveille barks during a class she's in, the class is canceled.
The Hill
25 minutes ago
- The Hill
Missouri AG sues Planned Parenthood for allegedly lying about dangers of abortion drugs
Missouri is suing Planned Parenthood for allegedly lying to patients about the risks of the abortion medication mifepristone. Missouri Attorney General Andrew Bailey (R) filed a lawsuit Wednesday in Jefferson City arguing that Planned Parenthood's claims that the abortion drug is safer than many other medications including penicillin and Tylenol are untrue and violate the state's consumer-protection law. Bailey claims that the nonprofit organization has lied about the safety of the drug to 'cut costs and boost revenue,' according to the lawsuit. The complaint also requests a court order to stop Planned Parenthood from 'continuing to promote the falsehoods,' in Missouri and for the organization to pay more than $1.8 million in civil penalties. The attorney general's office is also asking for the organization to be fined $1,000 in damages to every woman in the Show-Me State that has received abortion medication through one of is providers in the past five years. On top of this, it asks that the organization reimburse the state for Medicaid and other tax-payer-funded emergency care provided to people who suffered complications after taking mifepristone. 'We are going to hold these charlatans and death dealers accountable,' Bailey wrote in a post on social platform X about the suit. The crux of the lawsuit's argument comes down to a disagreement over how many people suffer adverse health effects after taking mifepristone. On the Food and Drug Administration's (FDA) warning label for the drug, it states that between 2.9 percent and 4.6 percent of people who have taken it along with misoprostol report visiting an emergency room afterwards. There are two drugs typically needed for a medication abortion: mifepristone and misoprostol. Mifepristone stops the pregnancy from growing while misoprostol induces cramping and bleeding to empty the uterus. More than 100 scientific studies across decades have looked at the efficacy and safety of the pair and all of them have found the drugs safe for use, according to an analysis from The New York Times. Bailey's lawsuit claims that the FDA's label is inaccurate and that 'recent studies' suggest the complication rate is much higher. The lawsuit does not cite a specific study to back up its claim and a spokesperson for the attorney general's office did not answer questions from The Hill about what data was used to back up its claim. The lawsuit does echo findings outlined in a deeply flawed study published in April by the conservative think tank the Ethics and Public Policy Center (EPPC) which states that after analyzing more than 865,000 prescribed mifepristone abortions, it determined that nearly 11 percent of women experienced a 'serious adverse event.' That's nearly 22 times higher than what the FDA reports. Bailey's lawsuit references a 'dataset' of more than 850,000 mifepristone abortions that identified 'serious adverse events' in more than 10 percent of women who took the drug. Medical researchers have criticized the EPPC study for its lack of transparency and for flaws in its methodology. One of the largest hiccups of the study is its inclusion of emergency room visits as one of the 'serious adverse events' that can happen after taking the abortion pill, health experts say. The EPPC study breaks down 'serious adverse events' into categories including hemorrhage, sepsis and emergency room visits. It looks as if emergency room visits were counted as adverse events even if health care workers determined the patient was healthy and released them without treatment. Some people might go to an emergency room after taking the abortion pill to confirm that they are no longer pregnant or to make sure that the bleeding they are experiencing is normal, two principal research scientists at the Guttmacher Institute noted in an op-ed last month. The lawsuit is the latest attack from conservative lawmakers on Planned Parenthood. Under the GOP's new tax and spending bill, the organization would lose its ability to receive Medicaid reimbursements for health services it provides for one year. The nonprofit sued the Trump administration over the provision and a federal judge granted the organization's request for a temporary injunction earlier this week.
New York Times
25 minutes ago
- New York Times
Kennedy Rescinds Endorsements for Some Flu Vaccines
Health Secretary Robert F. Kennedy Jr. on Tuesday formally rescinded federal recommendations for all flu vaccines containing thimerosal, a mercury-based preservative that the anti-vaccine movement has falsely linked to autism. The decision cements a move last month by vaccine advisers whom Mr. Kennedy named to the federal Advisory Committee on Immunization Practices after abruptly firing all 17 previous members. After hearing a presentation by the former leader of an anti-vaccine group, the panel had voted to walk back federal recommendations for all flu vaccines containing thimerosal. The decision will not affect most Americans seeking flu vaccines: Thimerosal is added to multidose vials of flu vaccines to prevent bacteria from growing, but it is not an ingredient of the single-dose vials administered to most people. During the 2024-25 respiratory virus season, only 3 percent of children and 2 percent of older adults received flu vaccines containing thimerosal, according to an analysis of electronic health records by Truveta, a company that analyzes such records. Still, multidose vials are needed in places where it is difficult to store many vaccines, such as nursing homes or mobile clinics serving remote rural areas. Mr. Kennedy's sign-off does not withdraw vaccines containing thimerosal from the market. But his rescinding the federal recommendation means that such shots may not be available to Americans, because insurance companies are no longer required to cover them. 'We urge global health authorities to follow this prudent example for the protection of children worldwide,' Mr. Kennedy said in a statement. Vaccine manufacturers have confirmed that they have the capacity to replace multidose vials containing mercury, ensuring that vaccine supplies for children and adults will 'remain uninterrupted,' the Department for Health and Human Services said in a statement. Federal health officials began removing thimerosal from childhood vaccines about 25 years ago, citing an abundance of caution despite a lack of data supporting safety concerns. Dozens of studies have shown thimerosal to be harmless. But the anti-vaccine community has long falsely maintained that the ingredient can cause neurological problems. At a meeting of the vaccine advisers last month, Lyn Redwood, a former leader of Children's Health Defense, the anti-vaccine group founded by Mr. Kennedy, claimed thimerosal was dangerous and toxic to children. Her presentation incorrectly said the only flu vaccine still containing thimerosal had 50 micrograms per dose, double the actual amount. The seven new advisers voted 5-1, with one abstention, to withdraw recommendations for flu vaccines containing thimerosal for children, pregnant women and other adults. The director of the Centers for Disease Control and Prevention typically accepts the recommendations of the committee. But the agency does not currently have a leader, and so the decision fell to Mr. Kennedy.
