The New York Times (7/6, Belluck) reports the FDA granted “full approval to the Alzheimer’s drug Leqembi (lecanemab), and Medicare said it would cover much of its high cost, laying the foundation for widespread use of a medication that can modestly slow cognitive decline in the early stages of the disease but also carries significant safety risks.” The agency’s “decision marks the first time in two decades that a drug for Alzheimer’s has received full approval, meaning that the agency concluded there is solid evidence of potential benefit.” However, the FDA “also added a so-called black-box warning…stating that in rare cases the drug can cause ‘serious and life-threatening events.’”

Reuters (7/6, Beasley, Steenhuysen) reports the drug, “which is given intravenously, has a U.S. list price of $26,500 per year.” The “new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies.” Additionally, “the drug’s new label includes data showing that the use of certain anti-coagulants with Leqembi has been linked to a risk of brain hemorrhage.”

Related Links:

— “New Federal Decisions Make Alzheimer’s Drug Leqembi Widely Accessible,”Pam Belluck, The New York Times , July 6, 2023

MedPage Today (7/6, Putka) reports, “Adults with cannabis use disorder had a moderately increased risk of morbidity and in-hospital mortality after major elective surgery compared with those without cannabis use disorder, a large retrospective study found.” Data show that “among 12,422 hospitalized patients, a composite outcome of perioperative complications and mortality occurred in 7.73% of the cannabis use disorder group and 6.57% of a matched control group.” The findings were published online in JAMA Surgery.

Related Links:

— MedPage Today (requires login and subscription)

HealthDay (7/6, Norton) reports, “Loneliness might be a true heartbreaker for people with diabetes – raising their odds of a heart attack even more than unhealthy lifestyle habits do,” according to findings from “a new study of over 18,000 adults with the blood sugar disease” published online in the European Heart Journal. The study team “found that people who reported feeling lonely were up to 26% more likely to suffer a heart attack or stroke in the next decade, compared to those who felt more socially connected.”

Related Links:

— “Loneliness Can Really Break a Heart in People With Diabetes,”Amy Norton, HealthDay, July 6, 2023

Healio (7/6, Young) reports, “Depression associated with hormonal contraception” (HC) “may indicate susceptibility to postpartum depression,” investigators concluded in findings published online April 26 in JAMA Psychiatry. In the “study of 188,648 first-time mothers, 5,722 (mean age, 26.7 years) had a history of depression associated with HC use and 18,431 (mean age, 27.1 years) had a history of depression not associated with HC.” The study revealed that “women with depression associated with HC initiation had a higher risk for postpartum depression.”

Related Links:

— “Depression associated with hormonal contraception indicates risk for postpartum depression,”Kate Young, Healio, July 6, 2023

Healio (7/5, Weldon) reports, “The FDA said Wednesday that it has warned six companies about illegally selling what it called ‘copycat’ edibles containing delta-8 tetrahydrocannabinol” (delta-8 THC), “a psychoactive and intoxicating substance found in cannabis sativa plants.” The substance “has not been approved by the FDA for any safe use.” In a July 5 press release, the agency “said the copycat products – often designed to resemble snack foods such as chips, cookies, candy and gummies – could be accidentally consumed by children in large quantities without realizing it.”

Related Links:

— “FDA warns companies about illegally selling ‘copycat’ edibles with delta-8 THC,”Rose Weldon, Healio, July 5, 2023