Summary

[Posted 31/May/2023]

AUDIENCE: Hematology, Infectious Disease

DETAILS: The U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.

This updated policy is based on the best available scientific evidence and is in line with policies in place in countries like the United Kingdom and Canada. It will potentially expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.

These final recommendations are consistent with the policy initially proposed in January. The FDA worked diligently to review and consider all comments submitted to the agency to finalize these recommendations as quickly as possible. "The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community," said Peter Marks, M.D., PhD., director of the FDA’s Center for Biologics Evaluation and Research. "The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place."

This policy eliminates time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Under the final guidance issued today, all prospective blood donors will answer a series of individual, risk-based questions to determine eligibility. All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.

Additionally, under these final recommendations, those taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred. Though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results. Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact. As stated in the guidance, individuals should not stop taking their prescribed medications, including PrEP, or PEP, in order to donate blood. The FDA remains committed to evaluating additional data and new technological developments as they become available to inform our donor eligibility recommendations.

The FDA has been evaluating alternatives to time-based deferrals for MSM and helping to facilitate the generation of scientific evidence that would support an individual risk based- assessment blood donor questionnaire. This scientific information has given the agency a solid foundation to support this new policy. The FDA strongly believes the implementation of an individual risk-based approach will not adversely affect the safety or availability of the U.S. blood supply.

The FDA carefully reviewed numerous data sources, including data from countries with similar HIV epidemiology that have implemented an individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, performance characteristics of nucleic acid testing for HIV and the FDA-funded Assessing Donor Variability And New Concepts in Eligibility study. The ADVANCE study examined the rates of HIV risk factors, such as anal sex and rates of HIV infection, as well as the usage of medications to treat or prevent HIV infection, among MSM study participants.

Copyright © FDA. All rights reserved.

Source: FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations. FDA. Published: May 11, 2023.

Summary

A Randomized Controlled Comparative Study

[Posted 19/May/2026]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: Early active treatment with isotretinoin and FMRF is safe and better than isotretinoin monotherapy over 44 weeks regarding severity, reduced erythema, and improved surface roughness in moderate-to-severe acne vulgaris. This encourages early and effective treatment of acne to mitigate acne scarring and improve patients' quality of life.

BACKGROUND: Oral isotretinoin is the standard therapy for severe acne. However, scarring may persist. Fractional microneedling radiofrequency (FMRF) improves both inflammatory lesions and scars with minimal downtime. In this study, we compare isotretinoin monotherapy and concurrent isotretinoin and FMRF for active acne regarding clinical outcomes. The GAGS scores of isotretinoin and FMRF were significantly lower than those of isotretinoin monotherapy from weeks 12-44 (-79.69% vs. -60.34% at week 44, respectively; p < 0.001). Isotretinoin and FMRF showed significantly greater lesion count reductions than isotretinoin monotherapy at follow-up visits from weeks 12-44. Isotretinoin and FMRF showed significantly lower hemoglobin levels than isotretinoin monotherapy at weeks 32 and 44 (p = 0.029 and p < 0.001, respectively). Skin surface roughness improved substantially and persistently from week 12-44.

DETAILS: In this parallel two-group comparative study, patients received either low-dose isotretinoin monotherapy for 20 weeks (n = 34) or low-dose isotretinoin concurrently with 5 monthly FMRF sessions (n = 36). Outcomes were assessed at baseline and weeks 12, 20, 24, 32, and 44. The primary endpoints were Global Acne Grading System (GAGS) scores and inflammatory/non-inflammatory lesion counts. Secondary endpoints were hemoglobin indices and skin roughness.

Copyright © Wiley Periodicals LLC. All rights reserved

Source: Disphanurat, W., Leeyangyuen, P,, and Srisantithum, B. Efficacy of Low-Dose Oral Isotretinoin Combined With Fractional Microneedle Radiofrequency Versus Low-Dose Oral Isotretinoin Monotherapy in the Treatment of Moderate-To-Severe Acne Vulgaris: A Randomized Controlled Comparative Study. Lasers in Surgery and Medicine. 2026; 58(4): 321-330. Published: April, 2026. DOI: 10.1002/lsm.70120.

Summary

[Posted 11/May/2026]

AUDIENCE: All Healthcare Professionals

KEY FINDINGS:

• Hantaviruses are a family of viruses that cause serious illness and sometimes death in people worldwide.
• The viruses are spread by infected rodents through their urine, feces, and saliva.
• Some hantaviruses cause hantavirus pulmonary syndrome (HPS).
• Early symptoms of HPS in people resemble many other respiratory illnesses, making HPS difficult to diagnose at illness onset.
• Healthcare providers should test a person for hantavirus if they have HPS-compatible symptoms and have had contact with rodents.

BACKGROUND: Hantaviruses are spread by rodents' body fluids and excrement. People mostly contract hantavirus by breathing in the virus. Most hantaviruses found in North, Central, and South America can cause hantavirus pulmonary syndrome (HPS). Andes virus, which is found in South America, has reportedly had person-to-person transmission.

DETAILS: Different hantaviruses are found in the United States. Most of these cause HPS, which primarily affects the lungs. Non-HPS hantavirus infection can also occur, where patients experience non-specific viral symptoms, but no cardiopulmonary symptoms. The hantaviruses that are found throughout the United States are not known to spread between people.

HPS initially causes flu-like symptoms that can progress to more severe illness where people have trouble breathing. It's important for people with HPS to begin treatment as early as possible to improve their chances of recovery. HPS is fatal in nearly 4 in 10 people who are infected.

Exposure risks

Anyone who has contact with hantavirus-carrying rodents, or their droppings, urine, saliva or nesting material is at risk of HPS. Rodent infestation in and around the home remains the primary risk for hantavirus exposure. Even healthy individuals are at risk for HPS infection if they have contact with the virus.

Andes virus can cause HPS and is the only type of hantavirus that is known to spread person-to-person.

How it spreads

Each hantavirus has one primary rodent that carries the disease. The most common hantavirus that causes HPS in the U.S. is spread by the deer mouse.

People can contract hantavirus if they have contact with urine, feces or saliva of a rodent carrying the virus. This can occur when people:

1. Breathe in hantavirus-contaminated air when cleaning up after rodents.
2. Touch contaminated objects and then touch their nose or mouth.
3. Are bitten or scratched by an infected rodent.
4. Eat food contaminated with hantavirus.

Cases normally occur in rural areas where forests, fields, and farms offer habitats for rodents. The animals can get into homes and barns, where they may leave urine or feces.

Dogs and cats are not known to become infected with hantavirus in the United States. Pets may bring infected rodents to people or into homes.

Testing and diagnosis

Assessing patients for hantavirus can be difficult early in the infection because symptoms are non-specific and resemble many other viral infections like influenza, legionnaire's, leptospirosis, mycoplasma, and Q fever. Because hantavirus resembles these infections, a blood test is often the only way to officially diagnose it.

To diagnose hantavirus or HPS, clinicians should understand:

• Disease symptoms and rodent exposure history
• Testing guidelines to identify the virus
• How to request testing support from CDC if needed, and
• How to report cases to CDC

Clinicians with a patient experiencing symptoms compatible with HPS and a potential rodent exposure should contact their state, tribal, local, or territorial health department.

Testing

CDC uses an enzyme-linked immunosorbent assay (ELISA) to detect IgM antibodies and diagnose acute infections with hantaviruses. This diagnostic method is used to diagnose both HPS and HFRS. Diagnostic testing can be performed at:

1. CDC
2. State labs running the CDC-developed assay
3. State public health labs using other diagnostic assays
4. Commercial labs

The criteria to report hantavirus-positive cases are based on the national case definition, which includes clinical symptoms (HPS or non-HPS) and acute laboratory diagnostic results, such as:

1. IgM positive
2. IgG positive with rising titers
3. Immunohistochemistry positive, or
4. PCR positive

Treatment and recovery

There is no specific treatment for hantavirus infection. If HPS is suspected, the patient needs emergency medical care immediately, preferably in the intensive care unit, even before diagnosis.

Early intensive medical care is critical because patients who have sudden acute disease can rapidly become severely sick and die. If a patient is experiencing full distress, it is less likely the treatment will be effective.

Patient management should include:

1. Monitoring and adjustment of cardiac function
2. Carefully administering fluids
3. Providing supplemental oxygen
4. Intubating and ventilating if needed

Suspected HPS patients should receive appropriate broad-spectrum antibiotic therapy, even if you're still waiting for diagnosis. Care should also include fever reducers and pain relievers.

While HPS can be quite severe, it has a short duration of critical disease. The cardiopulmonary dysfunction seen in HPS is most likely due to circulating inflammatory mediators. Autopsies performed on fatal cases did not show significant tissue damage.

Initiating extracorporeal membrane oxygenation (ECMO) at the earliest sign of decompensation has an 80 percent survival rate in patients despite cardiopulmonary collapse.

Within 24 hours of initial evaluation, most HPS patients develop some degree of hypotension. They also experience progressive evidence of pulmonary edema and hypoxia, usually requiring mechanical ventilation.

Patients with fatal infections often appear to have severe myocardial depression that progresses to sinus bradycardia with subsequent electromechanical dissociation, ventricular tachycardia, or fibrillation.

In patients with HPS, poor prognostic indicators include a plasma lactate of greater than 4.0 mmol/L or a cardiac index of less than 2.2 L/min/m2.

Pulmonary edema and pleural effusions are common, but multiorgan dysfunction syndrome is rarely seen. However, HPS patients sometimes have mildly impaired renal function. Survivors frequently become polyuric during convalescence and improve rapidly.

Intravenous ribavirin, a guanosine analogue, has been tested in patients with HPS. However, it was not shown to be effective for treatment of HPS.

Without adequate treatment, most deaths occur in patients with HPS within 24 to 48 hours of the cardiopulmonary phase onset.

Related diseases

Some hantaviruses cause kidney symptoms more than lung damage. When this occurs, it is called hemorrhagic fever with renal syndrome (HFRS).

Source: Clinician Brief: Hantavirus Pulmonary Syndrome (HPS). CDC. Published: May 8, 2026.

Summary

[Posted 8/May/2026]

AUDIENCE: Infectious Disease, Family Medicine

KEY FINDINGS: In two open-label trials, nirmatrelvir-ritonavir did not reduce the incidence of hospitalization or death among vaccinated higher-risk participants with SARS-CoV-2 infection.

BACKGROUND: Nirmatrelvir-ritonavir has been shown to reduce progression to severe illness from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in unvaccinated high-risk outpatients. The effectiveness of nirmatrelvir-ritonavir in persons who have been vaccinated, infected naturally, or both is unclear.

DETAILS: In two open-label platform trials (PANORAMIC in the United Kingdom and CanTreatCOVID in Canada), we enrolled higher-risk adults (>=50 years of age or >=18 years of age with coexisting conditions) in the community who tested positive for SARS-CoV-2 and had been unwell for 5 days or less. The participants were randomly assigned to receive usual care plus nirmatrelvir (300 mg)-ritonavir (100 mg) twice a day for 5 days or to receive usual care alone. The primary outcome was hospitalization or death from any cause within 28 days after randomization. From December 8, 2021, to September 30, 2024, a total of 3516 participants in the PANORAMIC trial and 716 participants in the CanTreatCOVID trial underwent randomization. In the PANORAMIC trial, 14 of 1698 participants (0.8%) in the nirmatrelvir-ritonavir group and 11 of 1673 participants (0.7%) in the usual-care group were hospitalized or died (adjusted odds ratio, 1.18; 95% Bayesian credible interval, 0.55 to 2.62; probability of superiority, 0.334). In the CanTreatCOVID trial, 2 of 343 participants (0.6%) in the nirmatrelvir-ritonavir group and 4 of 324 participants (1.2%) in the usual-care group were hospitalized or died (adjusted odds ratio, 0.48; 95% Bayesian credible interval, 0.08 to 2.23; probability of superiority, 0.830). In a substudy involving 634 participants, viral load was reduced by the end of treatment with nirmatrelvir-ritonavir. Serious adverse events with nirmatrelvir-ritonavir were reported in 9 participants in the PANORAMIC trial and in 4 participants in the CanTreatCOVID trial.

Copyright © Massachusetts Medical Society. All rights reserved.

Source: Butler, C. C., Pinto, A. D., Harris, V., et al. Oral Nirmatrelvir-Ritonavir for Covid-19 in Higher-Risk Outpatients. N Engl J Med. 2026; 394(16): 1583-1594. Published: April 22, 2026. DOI: 10.1056/NEJMoa2502457

Summary

[Posted 7/May/2026]

AUDIENCE: Ob/Gyn, Oncology

KEY FINDINGS: Recent actions by the U.S. Food and Drug Administration to update labeling for menopausal hormone therapy (MHT) represent an important shift toward evidence-based risk communication. By removing certain risks - cardiovascular disease, breast cancer, and probable dementia - from boxed warnings while retaining them in the Warnings and Precautions section, the FDA aims to provide a more balanced and clinically contextualized understanding of therapy risks and benefits.

BACKGROUND: The effects of menopause can make a woman's daily life much harder, and therapies approved by the U.S. Food and Drug Administration can help. But too many women might not use these treatments to lessen their menopause symptoms because of the risks associated with these drugs described in the drug labels' boxed warnings (the FDA's most prominent warnings).

DETAILS: The FDA has requested that drug companies remove risk statements about cardiovascular diseases, breast cancer, and probable dementia from boxed warnings for menopausal hormone therapy (MHT) - also called hormone replacement therapy (HRT). The FDA has requested that companies make changes to update information about the risks of these drugs so women and their health care providers can make the best decisions for their health. Several companies have already made, and FDA has approved, changes to their drug labels, and more companies may make changes.

Menopause and Symptoms Menopause is a natural stage in a woman's life when her menstrual periods permanently stop, marking the end of her reproductive years. This usually happens between ages 45 and 55.

When women go through menopause, their bodies produce less estrogen and progesterone. These lower hormone levels often cause symptoms that can significantly and adversely impact women's quality of life, including:

• Hot flashes (“hot flushes”), getting warm in the face, neck, or chest, with and without sweating.
• Night sweats, which may lead to problems sleeping and feeling tired, stressed, or tense.
• Vaginal changes, such as vaginal dryness and painful sex.
• Thinning of bones (osteoporosis), which may lead to loss of height and bone breaks.
• Treatments for menopausal symptoms include hormone therapy and non-hormonal therapy. The FDA has approved hormone therapies to help relieve hot flashes, night sweats, vaginal dryness, or dyspareunia (pain with sexual activity) - and that may reduce chances of getting osteoporosis. For women who cannot or choose not to take hormone treatments, the FDA has also approved three nonhormone therapies.

Types of Hormone Replacement Therapy There are four primary types of hormone replacement therapy: systemic combination therapy (estrogen and progestogen), systemic estrogen-alone therapy, systemic progestogen-alone therapy for women with a uterus using systemic estrogen-alone therapy, and topical vaginal estrogen therapy. Your health care provider can help you decide the best treatment based on your individual symptoms, medical history, and preferences.

Combination Therapy (Estrogen Progestogen Therapy or EPT): This therapy combines doses of estrogen and progestin (hormones that act like progesterone) or progesterone and is used in women with a uterus. Combination therapy most commonly comes in pills or skin patches.

Systemic Estrogen-Alone Therapy: This therapy contains only estrogen and comes in pills, skin patches, spray, gel, and vaginal ring. It is usually used in women who have had their uterus removed (hysterectomy). It can also be used in women with a uterus if progesterone-alone therapy is also added.

Progestogen-Alone Therapy: This therapy contains only progesterone or progestin and comes in pills. It is added to systemic estrogen-alone therapy in women with a uterus to protect against cancer of the uterus.

Topical Vaginal Estrogen Therapy: This therapy involves using estrogen applied topically to the vaginal area to treat vaginal symptoms. Forms of topical estrogen therapy include vaginal cream, tablet, insert, and ring.

What's a Boxed Warning? A boxed warning is the most prominent safety warning for FDA-approved prescription drugs. A boxed warning can be used to inform health care providers and patients about potentially serious or life-threatening risks essential to consider when patients and their health care providers assess a drug's risks and benefits.

Why the FDA Is Taking This Action Based on the FDA's analysis, the agency has requested drug sponsors of all HRT products that contain estrogen or progestogen and in all dose forms to remove language about the risk of cardiovascular disease, breast cancer, and probable dementia from the boxed warning, as well as make other safety-related labeling changes. FDA has not requested that drug sponsors remove the risks of cardiovascular disease and breast cancer from the Warnings and Precautions section of the labeling.

The FDA is not requesting removal of the boxed warning for endometrial cancer for systemic estrogen-alone products.

Millions of women have avoided hormone replacement therapy since the early 2000s because of fears about cancer and heart disease risks. The FDA is asking for these labeling changes so women and their doctors have access to updated information on the benefits and risks of these medications so they can make informed decisions.

Source: Hormone Replacement Therapies Can Help Women with Bothersome Menopausal Symptoms. FDA. Published: February 13, 2026.

Summary

A Nonrandomized Clinical Cohort Trial.

[Posted 25/Apr/2026]

AUDIENCE: Oncology, Ob/Gyn

KEY FINDINGS: In this clinical cohort trial of patients with nonrapidly progressive, newly diagnosed MBC before initiation of first-line systemic therapy, early FDG-PET after only 2 weeks of treatment identified patients with MBC with distinct long-term outcomes. Incorporating early FDG-PET can improve outcome estimation of standard CT assessment.

BACKGROUND: Optimizing treatment decisions in metastatic breast cancer (MBC) can alleviate patients' burden and improve quality of life. Whether 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) can be used to better estimate outcomes is unknown. The study was conducted to evaluate clinical utility of early metabolic change on FDG-PET for improving outcome estimation compared with standard diagnostic evaluation in patients with newly diagnosed MBC. Clinical utility of molecular imaging to improve outcome estimation of standard diagnostics defined as the capacity to identify poor patient outcomes. Measures were PD at 8 weeks, PFS, and OS. The analysis included 200 patients (median [range] age, 61 [32-84] years; 198 females [99%] and 2 males [1%]). Non-PD on early FDG-PET had a negative predictive value (NPV) of 94.7% (95% CI, 89.5%-97.4%) for non-PD on 8-week CT. This was similar in all MBC subtypes and bone-only disease. Patients with SOC treatment and non-PD on early FDG-PET (n = 133) had a median PFS of 19.4 (95% CI, 15.2-22.8) months and OS of 39.4 (95% CI, 33.7-48.3) months compared to 4.1 (95% CI, 3.3-15.5) months and 18.5 (95% 3 CI, 7.0-33.0) months, respectively (P .001 for both). Patients with non-PD on 8-week CT but with PD on early FDG-PET had a median (IQR) PFS and OS of 9.5 (4.1-18.1) and 19.4 (8.7-33.0) months compared to 22.3 (15.3-96.1) months and 40.1 (23.4-72.7) months without PD.

DETAILS: The multicenter IMPACT-MBC clinical cohort trial enrolled patients with nonrapidly progressive, newly diagnosed MBC from August 2013 to May 2018, before initiation of first-line systemic therapy. Baseline assessment included metastasis biopsy procedure and FDG-PET and CT imaging. Early FDG-PET was performed after 2 weeks of treatment, and CT response evaluation after 8 weeks. Clinical utility was defined as the ability of early FDG-PET to estimate progressive disease (PD) on CT, progression-free survival (PFS), and overall survival (OS). Data were analyzed from October 19, 2025, to February 13, 2026.

Copyright © American Medical Association. All Rights Reserved.

Source: van Geel, J. J. L., Eisses, B., Elias, S. G., et al. 18F-Fluorodeoxyglucose Positron Emission Tomography for Estimating Outcomes After Initial Treatment for Metastatic Breast Cancer: A Nonrandomized Clinical Cohort Trial. XXXXXX. Published: April 16,, 2026. DOI: 10.1001/jamaoncol.2026.0767