Clinical Trial Results Support FDA’s Decision To Approve Brexpiprazole For Alzheimer’s Disease Agitation

Psychiatric News (11/6) reports, “The Food and Drug Administration’s decision to approve brexpiprazole (Rexulti) for the treatment of agitation related to Alzheimer’s disease in May was met with a mixed response.” However, “JAMA Neurology published the results of a key phase 3 clinical trial used in the FDA’s decision.” The study found that after 12 weeks, participants’ average Cohen-Mansfield Agitation Inventory (CMAI) scores “dropped by 22.6 points in the combined brexpiprazole groups and 17.3 points in the placebo group, which was a statistically significant difference.”

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— “Clinical Trial Supports Use of Brexpiprazole for Alzheimer’s Agitation, Study Suggests , Psychiatric News, November 6, 2023

Ketamine Emerges As New Option To Treat Pain, Worrying Some Experts

The AP (11/6, Perrone) reports, “As U.S. doctors scale back their use of opioid painkillers, a new option for hard-to-treat pain is taking root: ketamine, the decades-old surgical drug that is now a trendy psychedelic therapy.” Ketamine prescriptions “have soared in recent years, driven by for-profit clinics and telehealth services offering the medication as a treatment for pain, depression, anxiety and other conditions.” However, “with limited research on its effectiveness against pain, some experts worry the U.S. may be repeating mistakes that gave rise to the opioid crisis: overprescribing a questionable drug that carries significant safety and abuse risks.”

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— “Mind-altering ketamine becomes latest pain treatment, despite little research or regulation,”Matthew Perrone , AP, November 6, 2023

Analysis Finds That Following Firearm Injuries Among Children, Family Members Experience Sharp Increase In Psychiatric Disorders

The New York Times (11/6, Barry) reports, “With each mass shooting, Americans look to one grim indicator – the number of dead – as a measure of the destructive impact.” However, “damage left behind by gunshot wounds reverberates among survivors and families, sending mental health disorders soaring and shifting huge burdens onto the health care system, a new analysis of private health insurance claims shows.” The analysis published in Health Affairs found that “for families in which a child died of a gunshot wound, surviving family members experienced a sharp increase in psychiatric disorders, taking more psychiatric medications and making more visits to mental health professionals: Fathers had a 5.3-fold increase in treatment for psychiatric disorders in the year after the death; mothers had a 3.6-fold increase; and surviving siblings had a 2.3-fold increase.”

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— “The New York Times (requires login and subscription)

Lawmakers open investigation into FDA’s handling of drug shortages

The Hill (11/3, Weixel) reported Republican lawmakers in the House “are launching a probe into how the Food and Drug Administration (FDA) is responding to a growing number of prescription drug shortages in the country.” House Committee on Oversight and Accountability members wrote a letter to FDA Commissioner Robert Califf, MD, that “requested documents and a staff-level briefing to understand the agency’s role in monitoring drug shortages and mitigation strategies.” According to the FDA “drug tracker,” there are “nearly 130 drugs currently in short supply, including generic cancer drugs, amoxicillin, albuterol and Adderall. Earlier this year, there was a shortage of children’s acetaminophen and ibuprofen.”

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— “House GOP opens probe into FDA response to drug shortages,”Nathaniel Weixel, The Hill, November 3, 2023

DEA: Drug Manufacturers Agree To Increase Production Of Stimulants Like Adderall In Short Supply

The Hill (11/3, Choi) reported drugmakers “have agreed to increase their production of stimulant medications like Adderall to help address the ongoing shortage in the U.S., with the Drug Enforcement Administration (DEA) making changes to its quota process.” DEA Administrator Anne Milgram said the agency contacted 18 drugmakers and got positive responses from 17 of them to increase production under higher quotas. Additionally, Milgram “shared steps the DEA was taking to increase transparency among drugmakers including requiring them to submit anticipated production timelines to the DEA before they receive their quota allotments; requiring manufacturers to apply for such allotments on a quarterly basis as opposed to annually; requiring digital reporting on how much of a drug is being produced and shipped; [and] specifying whether a company’s quota allotment is for domestic production or export.”

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— “Adderall makers agree to increase production: DEA,”Joseph Choi , The Hill, November 3, 2023

Maui Wildfire Survivors Experiencing Mental Health Crises

NBC News (11/5, Bendix, Lozano) reports that “more than two months after a ferocious wildfire burned” a “West Maui community to the ground, killing at least 97 people…survivors say the trauma is as real now as the day it sent hundreds of people fleeing for their lives as flames chewed through their neighborhoods and thick, black smoke filled the skies.” Many residents “have trouble eating, sleeping or getting out of bed, and experience nightmares or flashbacks triggered by noises like the sound of a fire engine or a gust of strong wind. They describe a profound sadness, or heaviness – what Native Hawaiians call kaumaha.”

Related Links:

— “Maui wildfires lead to dire mental health crisis in Lahaina,”Alicia Victoria Lozano and Aria Bendix, NBC News, November 5, 2023

Poll Finds Around 20% Of Adults Say Daylight Savings Time Affects Their Mental Health

CBS News (11/4, Sundby) reported daylight savings time has “caused considerable consternation amongst Americans. Parents who want their children to head to school in the daylight can appreciate ‘falling back’ to standard time, but those who want the sun to shine long enough to play in the park after classes may want to keep daylight saving time year-round.” Around 20% of “adults said the time change has affected their mental health in a negative way, according to a poll from the American Psychiatric Association that was conducted in September.” APA President Petros Levounis, M.D., M.A., said, “This is a very, very high number of people who actually say that the change in time will give them some depression, some discomfort, some uneasiness.”

The Hill (11/3, Shepherd) reported, “Efforts to make daylight saving time the new, permanent standard time have been largely unsuccessful.” Even though the US Senate “passed the Sunshine Protection Act in March 2022, a bipartisan bill that would have put an end to the biannual changing of clocks, the proposal ultimately stalled in the House and has since made little progress.”

NPR (11/3, Treisman) reported, “About 5% of adults in the U.S. experience” seasonal affective disorder (SAD), “and it typically lasts about 40% of the year…says” the APA. Symptoms “include feelings of sadness, fatigue, cravings of carbs and starch and associated weight gain.” Physicians “believe SAD is linked to the reduced sunlight exposure and circadian rhythm disruption that are hallmarks of the winter months.”

Related Links:

— “When does the time change for daylight saving time 2023? What to know before clocks “fall back”,”Alex Sundby , CBS News, November 4, 2023

Survey Shows Declines In Number Of High School Students Who Report Vaping

The New York Times (11/2, Jewett) reports, “The number of high school students who reported using e-cigarettes fell to 10 percent in the spring of this year from 14 percent last year, according to the results of an annual survey released on Thursday by federal health agencies.” However, “vaping rose slightly among middle school students, to 4.6 percent this year from 3.3 percent in 2022.” Meanwhile, “the use of traditional cigarettes among high school students remained at a record low of less than 2 percent.”

The AP (11/2, Stobbe, Perrone) reports the survey also found “nearly 90% of the students who vape used flavored products, with fruit and candy flavors topping the list.” Over the past “three years, federal and state laws and regulations have banned nearly all teen-preferred flavors from small, cartridge-based e-cigarettes, like Juul.” However, “the FDA has still struggled to regulate the sprawling vaping landscape, which now includes hundreds of brands sold in flavors like gummy bear and watermelon.”

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— “The New York Times (requires login and subscription)

Older Patients Who Receive Thyroid Hormone Therapy And Experience Low Thyrotropin Have Increased Risk For Dementia, Other Cognitive Problems, Study Finds

Medscape (11/2, Warren, Subscription Publication) reports, “Patients age 65 and older who receive thyroid hormone therapy and experience low thyrotropin are at increased risk for dementia and other cognitive problems, according to” a study. Investigators “also found that women were more likely to have low levels of thyrotropin…than men and were more likely to be overtreated.” The findings were published in JAMA Internal Medicine.

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Maternal Depressive Symptom Trajectories Remained Stable Throughout Pregnancy And Two Years Postpartum, Researchers Say

Healio (11/1, Welsh) reports, “Maternal depressive symptom trajectories remained stable throughout pregnancy and up to 2 years after childbirth, which suggests focusing not only on postpartum depression but depression throughout pregnancy, researchers reported.” In the study published in JAMA Network Open, “researchers categorized all participants based on level of self-reported depressive symptoms as low, mild or high. All participants had stable depressive symptom trajectories from pregnancy to 2 years postpartum.”

Related Links:

— “Depressive symptoms remain stable during pregnancy, up to 2 years after childbirth,”Erin T. Welsh, Healio, November 1, 2023