The Food and Drug Administration is tightening safety rules for Eisai and Biogen’s Alzheimer’s drug Leqembi, calling for an earlier MRI scan between the second and third infusions of the biologic. This comes after regulators identified six deaths linked to brain swelling, or amyloid-related imaging abnormalities with edema. Up until now, scans were only required before the fifth, seventh, and 14th doses.
The move brings Leqembi closer in line with Eli Lilly’s rival Kisunla, which already mandates earlier monitoring, as regulators aim to catch potentially fatal complications sooner.
FACT-CHECK
SSRIs and gender-affirming care don’t cause violence
Kennedy revived one of his longtime conspiracy theories yesterday when he announced in public appearances that the NIH will be studying the link between psychiatric medication and mass shootings, despite the overwhelming lack of evidence of any connection.
Speaking on Fox News about the perpetrator of a school shooting in Minneapolis this week, Kennedy talked about selective serotonin reuptake inhibitors, or SSRIs, which are commonly used treatments for depression that include the drugs sold as Prozac and Zoloft. Kennedy indicated that there is a black box warning on the drugs indicating that they can increase the risk of suicide and homicide — that is incorrect, as STAT’s Matt Herper points out.
Kennedy was also asked if the drugs used in gender-affirming therapy can result in violence, as the shooter was a transgender woman. Though Kennedy did not answer this question, there is no evidence these treatments cause people to become violent, and it is not known what medicines the shooter was taking. Read more here.
