JAMA – August 2025 Medical News Podcast

Introduction

Rise of 7-OH, a Kratom-Derived Compound

Abbasi: Welcome to our August news roundup. I’m Jennifer Abbasi. Today, we’re covering a new, legally available opioid-like substance sold in vape shops, the growing real-world data on Alzheimer’s anti-amyloid therapies, and a controversial FDA panel that has placed the use of SSRIs during pregnancy in the spotlight.

First, staff writer Samantha Anderer joins us to discuss 7-OH, a compound with opioid effects that consumers can purchase legally. Sammy, thanks for being here.

Anderer: Happy to be here, Jen.

Abbasi: Let’s start with the basics. What is 7-OH, and why are health officials concerned?

Anderer: 7-hydroxymitragynine, or 7-OH, is a natural component of the kratom plant, but it’s only present in small quantities. The FDA is now warning the public and clinicians about new, highly concentrated 7-OH products being sold legally at vape shops, gas stations, and online.

This compound activates opioid receptors, producing pain relief, euphoria, and sedation. Experts report its use is growing among both chronic pain patients seeking alternatives and individuals seeking a high. A new FDA report confirms it has a high potential for abuse.

According to Caitlin Brown of America’s Poison Centers, overdose and withdrawal symptoms mirror those of traditional opioids: agitation, nausea, vomiting, and tachycardia. In severe cases, it can cause respiratory depression or central nervous system depression.

The numbers are rising quickly: Poison centers reported 53 cases by May 30th, half of which were intentional abuse, including six cases in children. By the end of July, that number had jumped to 165. The accessibility is a major concern—for just $15 to $30, anyone can buy these products over-the-counter as flavored gummies, tablets, or energy drinks, which are particularly appealing to youth.

Abbasi: You mentioned it’s related to kratom. How are they different?

Anderer: While 7-OH is one of kratom’s two main psychoactive components, these new products contain unnaturally high, concentrated amounts. Producers are likely using synthetic processes to convert a more abundant but less potent kratom component into 7-OH. It’s important to note the FDA is specifically targeting these high-concentration 7-OH products, not kratom itself at this time.

Abbasi: What actions are agencies taking?

Anderer: The U.S. Department of Health and Human Services and the FDA are concerned these easily available products could signal a new phase in the opioid crisis. The FDA has recommended that the Drug Enforcement Administration (DEA) classify 7-OH as a controlled substance to restrict its sale. They’ve also released a scientific assessment, a letter to healthcare professionals, and public educational materials.

Abbasi: Thank you, Sammy. We’ll continue to follow this closely.

Abbasi: Now, let’s turn to Alzheimer’s disease. With anti-amyloid therapies available for a couple of years, we’re starting to gather real-world evidence. Lead senior staff writer Rita Rubin is here to share what we’re learning.

Rubin: Thanks, Jen. It’s been two years since the FDA granted its first traditional approval for an anti-amyloid therapy, lecanemab, followed by donanemab a year later. These drugs target the amyloid beta plaque that is a hallmark of Alzheimer’s.

While many past therapies successfully removed plaque but showed no clinical benefit, the Phase III trials for these new drugs were different: Lecanemab slowed disease progression by 27% over 18 months, and donanemab by 22.3%.

Now, physicians are reporting on real-world experience. At a recent Alzheimer’s conference, a session was devoted to lecanemab. Physicians and families reported high satisfaction, though researchers noted this could be influenced by the significant effort required to access the expensive treatment.

The treatment regimens are intensive. Lecanemab requires bi-weekly infusions for 18 months, followed by monthly maintenance infusions for an unclear duration. Donanemab is administered monthly until a patient’s amyloid plaque drops below a certain threshold, at which point treatment stops.

The most serious adverse event from the trials was ARIA—amyloid-related imaging abnormalities—which involves brain swelling or bleeding. It’s often asymptomatic but can be serious or even life-threatening. Presented data suggested lecanemab has a lower rate of ARIA than donanemab.

So far, no new safety signals have emerged post-approval. However, measuring their real-world effectiveness in slowing disease progression is challenging without a placebo group for comparison.

Abbasi: Why do some dementia patients not qualify for these treatments?

Rubin: They aren’t for everyone. First, a physician must confirm the presence of amyloid plaque via a PET scan—there’s no point in treatment without the target. The most common reason for disqualification is that patients seek care too late. These drugs are approved only for those with mild cognitive impairment or early Alzheimer’s disease, the populations in which they were proven effective.

Abbasi: Thank you, Rita. [Brief aside on a related JAMA report about Alzheimer’s biomarkers in newborns.]

Abbasi: Now, switching topics: We’re discussing SSRIs during pregnancy. A recent FDA panel on their safety has drawn criticism from medical groups. Associate Managing Editor Kate Schweitzer is here to explain.

Schweitzer: Thanks, Jen. Last month, the FDA convened a panel to discuss SSRIs—Selective Serotonin Reuptake Inhibitors—in pregnancy. This was controversial because, while ACOG recommends SSRIs as a first-line treatment for perinatal depression, most panel speakers criticized their use and focused heavily on risks.

An FDA spokesperson stated the panel was meant to promote evidence-based standards. However, critics, including Postpartum Support International, noted that many participants lacked expertise in perinatal mental health.

There is universal agreement that more research is needed on SSRIs in pregnancy. However, funding cuts have delayed a planned federal working group on this very topic. Furthermore, ethical concerns have historically limited randomized clinical trials in pregnant patients, so most existing data comes from observational studies, which have inherent limitations.

Abbasi: So what do we know about the risks and benefits?

Schweitzer: Research shows SSRIs are not associated with a significant increase in major birth defects. They are also not linked to autism after controlling for the underlying maternal mental health condition, which is a major confounding variable in many studies.

A consistent adverse effect is neonatal adaptation syndrome, which affects 20-30% of exposed newborns. Symptoms like irritability and feeding issues usually resolve within days and show no long-term consequences.

Conversely, the risks of untreated mental illness are severe. These include suicidal ideation, worsened outcomes for conditions like gestational diabetes, preterm birth, low birth weight, and impaired child development. Untreated depression also increases the likelihood of substance use.

Tragically, CDC data shows over 10% of pregnancy-related deaths are linked to a mental health condition, with over 60% of those being suicide. Deaths from mental illness were also more frequently deemed preventable.

Abbasi: Which patients benefit from SSRIs during pregnancy?

Schweitzer: It’s not one-size-fits-all. It depends on the risk of relapse and response to other treatments. A meta-analysis found that pregnant people with severe or recurrent depression were more than twice as likely to relapse if they discontinued medication. However, this association wasn’t seen in those with mild depression, who often successfully manage symptoms with therapy and lifestyle changes alone.

A key theme was that patients often receive inadequate counseling about these options. Furthermore, a study found that only half of people with prenatal depression are diagnosed, and a mere 14% receive any treatment at all.

Some panelists supported stronger warning labels to address education gaps. The FDA has not indicated if it will pursue label changes or new regulations, which could affect insurance coverage. Critics warn that the panel’s one-sided focus on risks could deter patients who would genuinely benefit from treatment. The consensus among experts is clear: there is no risk-free choice. The decision must be made by patients and clinicians together, based on individual needs.

Abbasi: Thank you, Kate.

Conclusion

From the emerging public health threat of readily available 7-OH to the nuanced realities of cutting-edge Alzheimer’s treatments and the deeply personal decisions surrounding perinatal mental health, this month’s stories underscore a common theme: the critical need for evidence-based, patient-centered care. As these situations evolve, they highlight the continuous challenge of balancing innovation with safety, access with regulation, and clinical guidance with individual patient needs. The ongoing work to understand these complexities remains paramount for improving health outcomes. Thank you for joining us for this roundup of essential medical news.