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.”

Related Links:

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

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.”

Related Links:

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

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.”

Related Links:

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

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.”

Related Links:

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

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.”

Related Links:

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