Drug and Guideline Updates

TL;DR:

FDA asked makers to remove suicide-risk warnings from GLP-1 labels on Jan 13, 2026.
FDA approved Zycubo for Menkes disease on Jan 12, 2026.
WHO issued updated HIV clinical management guidance on Jan 7, 2026.
Clinicians should update counseling, screening, and care plans now.
Patients gain clarity on GLP-1 safety and new options in rare disease and HIV care.

On January 13, 2026, the U.S. Food and Drug Administration asked companies to remove suicidal ideation and behavior warnings from labels of GLP-1 receptor agonists that include this language now, such as Saxenda, Wegovy, and Zepbound. FDA said a large meta-analysis and Sentinel claims study found no increased risk compared with placebo or SGLT2 inhibitors. Counseling should still cover mood changes and when to seek help.

On January 12, 2026, FDA approved Zycubo, a copper histidinate injection, as the first treatment for Menkes disease in children. Early treatment, within four weeks of birth, cut the risk of death by 78 percent versus external controls, based on two open-label studies. Zycubo is given subcutaneously and carries typical monitoring needs for copper overload.

On January 7, 2026, the World Health Organization released updated HIV clinical management recommendations. The guidance confirms dolutegravir-based regimens as first-line and supports long-acting injectables in select cases. It also updates vertical transmission prevention and names weekly 3HP as the preferred TB preventive therapy for people with HIV.

Why this matters

These moves affect day-to-day decisions in obesity care, rare pediatric disease, and HIV services. Label language influences patient trust. A first-ever Menkes therapy changes newborn care pathways. WHO’s update helps align national protocols and donor procurement. Together, they shape counseling, screening, and access in 2026.

GLP-1 label change, at a glance

What FDA found

FDA reviewed 91 randomized trials with more than 100,000 participants and a Sentinel cohort of over 2.2 million GLP-1 or SGLT2 new users. Neither showed an increased risk of suicidal thoughts or behavior with GLP-1 drugs. FDA asked holders to remove the warning to keep labels consistent across the class.

What clinicians should do now

Continue standard depression screening during obesity and diabetes care.
Explain that FDA found no increased risk, but to report mood changes.
Keep reporting adverse events to MedWatch.

What patients can expect

Patients on Saxenda, Wegovy, or Zepbound will likely see updated labeling later this year. Those using GLP-1s for diabetes already have labels without this warning. The change should reduce confusion and stigma while keeping safety monitoring in place.

First Menkes therapy: Zycubo

The disease

Menkes disease is a rare, often fatal genetic disorder that blocks copper absorption. Infants develop seizures, failure to thrive, and severe neurodevelopmental delay. Most with the classic form do not survive past early childhood without treatment.

The approval

FDA approved Zycubo for pediatric patients with Menkes disease. In pooled open-label data against external controls, early treatment improved survival and extended life beyond six years for many children, while none in the untreated group lived past six years. The drug received Priority Review, Fast Track, Breakthrough, and Orphan designations.

Care implications

Build newborn screening and rapid confirmatory testing pathways where feasible.
If Menkes is suspected prenatally or at birth, coordinate early referral to centers able to start therapy within weeks.
Monitor for copper accumulation and common adverse events.

WHO’s HIV clinical management update

Core treatment points

WHO reaffirms dolutegravir-based first-line therapy and sets darunavir/ritonavir as the preferred protease inhibitor when needed. It allows reuse of tenofovir or abacavir in subsequent regimens for programmatic and cost benefits. Long-acting injectables and two-drug oral options are now tools for selected, stable patients facing adherence barriers.

Preventing vertical transmission

WHO continues to back exclusive breastfeeding with maternal ART, with six weeks of infant prophylaxis for all exposed infants, and enhanced triple-drug prophylaxis for those at higher risk. Extended prophylaxis can continue until maternal viral suppression or the end of breastfeeding.

TB prevention in people with HIV

WHO recommends weekly isoniazid plus rifapentine for 12 doses, the 3HP regimen, as the preferred TB preventive therapy for adults and adolescents with HIV, to improve uptake and completion.

Quick implementation checklist

Area	Action this week	Owner
GLP-1 counseling	Update talking points to reflect FDA’s no-increased-risk finding. Keep mood screening.	Clinicians
Pharmacovigilance	Report GLP-1 adverse events to MedWatch.	Clinics, Pharmacies
Menkes pathways	Map rapid referral, testing, and initiation steps for newborns.	Hospital leads
HIV ART	Align first-line and failure-switch protocols with WHO’s dolutegravir-based approach.	HIV program leads
PMTCT	Update infant prophylaxis protocols, including high-risk triple coverage.	Maternal-child health
TB preventive therapy	Stock and schedule 3HP for eligible patients with HIV.	Pharmacy, TB/HIV teams

What happens next

For GLP-1s, companies will submit labeling updates. Practices should not delay communication, since FDA’s recommendation is public and clear. Watch for payer and guideline alignments.

For Zycubo, expect specialty centers to publish care pathways and payer policies. Newborn screening committees may weigh targeted approaches where incidence supports it.

For HIV programs, WHO’s recommendations will flow into national guidelines over the next months. Procurement plans should reflect DTG-based regimens and 3HP demand. Training should cover new regimen reuse options and long-acting therapy selection.

Bottom line

This week brought clarity on GLP-1 safety language, a first therapy for a fatal rare disease, and a practical HIV care update. The changes are actionable today, and they steer policy and practice for 2026.