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Pause in use of live-attenuated chikungunya vaccine in older adults due to safety concerns
Drug regulatory agencies have recommended a pause in the use of the live-attenuated chikungunya vaccine (known commercially as Ixchiq®) in older adults, due to reports of serious adverse events during postmarketing use of the vaccine.
The Food and Drug Administration (FDA) has recommended a pause in the use of the live-attenuated vaccine in people ages ≥60 years while it investigates the issue and conducts an updated assessment of the benefits and risks in people in this age group. The Centers for Disease Control and Prevention (CDC) supports this recommendation.
The European Medicines Agency (EMA) has also suspended use of the vaccine in older adults, but with a higher age cut-off of ≥65 years. Use of the vaccine is now contraindicated in adults ages ≥65 years in affected regions. The EMA has introduced this temporary measure while it conducts a thorough safety review of the vaccine, and determines whether any changes are required to the terms of its marketing authorization.
The recommendations come after reports of serious adverse events occurring in older people who have received the vaccine. As of 7 May 2025, 17 serious adverse events, including two deaths, have been reported globally in people ages between 62 and 89 years. The fatal cases were due to encephalitis and aspiration pneumonia. Many of the people experiencing serious adverse events had pre-existing comorbidities, and it is unknown whether there is a causal relationship with the vaccine as yet.
The live-attenuated vaccine may still be used in people <60 years of age (in the US) and <65 years of age (in Europe) within its license. The vaccine is contraindicated in people who are immunocompromised.
The live-attenuated vaccine was the first vaccine to be approved for the prevention of disease caused by chikungunya virus. Over 80,000 doses have been used worldwide since its approval. More recently, an adjuvanted recombinant virus-like particle vaccine (known commercially as Vimkunya®) was approved for the prevention of disease caused by chikungunya virus; this vaccine is not currently affected by the restrictions and may be used in people ages ≥60 years.
Approximately 18.7 million cases of chikungunya virus infection have been reported across 110 countries between 2011 and 2020, with most of the burden in the Latin American and Caribbean region.
US FDA approves gepotidacin, a first-in-class antibiotic for UTIs in women
Gepotidacin has recently been approved by the US Food and Drug Administration (FDA) - the first in a new class of oral antibiotics for adult females with uncomplicated UTIs. This new treatment option is appropriate for uUTIs caused by: Array, Array, Array complex, Array, and Array. It has also been approved for use in children ≥12 years of age weighing at least 40 kg.
Gepotidacin is a first-in-class triazaacenaphthylene bacterial type II topoisomerase inhibitor with a novel mechanism of action; inhibiting bacterial DNA replication by blocking two essential topoisomerase enzymes. Mutations in both enzymes would likely be necessary for resistance to occur, raising hopes that the drug will be able to maintain long-term effectiveness and have a lower potential for resistance.
In two randomized clinical trials (EAGLE-2 and EAGLE-3), gepotidacin was noninferior to nitrofurantoin in both studies and superior to nitrofurantoin in EAGLE-3.
Gepotidacin has the potential to cause QTc prolongation, so should be avoided in patients with a history of QTc prolongation, or those with relevant pre-existing cardiac disease, and in patients receiving drugs that prolong the QTc interval. It also should be avoided in patients taking strong CYP3A4 inhibitors, in patients with severe hepatic impairment (Child-Pugh Class C), and in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min).
Urinary tract infections (UTIs) are among the most common conditions encountered by clinicians across a range of settings. The development of gepotidacin marks a major milestone, as it is the first new oral antibiotic for UTIs in more than 20 years. It is anticipated that gepotidacin will be available in the US in the second half of 2025. Gepotidacin has not been approved in Europe as yet.
WHO reaffirms mpox outbreak in Africa still meets criteria for a public health emergency of international concern
The World Health Organization (WHO) declared the current mpox outbreak in Africa a public health emergency of international concern (PHEIC) on the 14th August 2024, and this was reaffirmed on 27 February 2025. PHEIC status aims to accelerate funding, research, and international public health measures and cooperation to contain a disease, and is the WHO’s highest level of alert possible.
The PHEIC has been declared due to the following reasons:
- An upsurge of mpox cases in parts of Africa
- Emergence of a new variant of mpox, known as clade Ib, which appears to be spread mainly by sexual transmission
- Rapid spread of the clade Ib variant in the Eastern Democratic Republic of the Congo (DRC) and reports of cases in several neighboring countries (e.g., Burundi, Kenya, Rwanda, Uganda)
- Potential to spread further across other countries in Africa, and possibly outside of Africa
In the past 12 months, over 23,000 laboratory-confirmed cases of mpox have been reported in Africa, including 98 deaths (as of 30 March 2025). The three countries with the majority of cases are the DRC, Uganda, and Burundi.
Although the epidemiology is not fully understood, the current spread of mpox in Africa is attributed to two distinct ongoing outbreaks in the DRC:
- A clade Ia outbreak primarily in mpox-endemic areas mainly affecting children.
- A clade Ib outbreak in the eastern part of the country that has been rapidly spreading and reaching neighboring countries that have not previously reported mpox cases. The outbreak is affecting both children and adults, and is spreading rapidly among adults through close contact including sexual contact identified within networks of sex workers and their clients.
Travel-related cases of clade Ib mpox have now also been reported in countries outside of Africa including India, Sweden, Thailand, Germany, the US, the UK, Belgium, Canada, and France.
Situation in the UK
- The first case of clade Ib mpox detected in the UK was reported on 30 October 2024. As of 10 February 2025, nine confirmed cases of clade Ib mpox had been reported in the UK. Most cases had a travel history to Uganda. However, three cases were detected in household contacts of the first case (who had recently traveled to countries in Africa currently experiencing mpox outbreaks).
- A single confirmed case with no reported travel history and no reported link with a previously confirmed case was reported in the UK in early April 2025. All contacts were followed up and no further cases were identified. Investigations into the source of the infection are ongoing.
- The wider risk to the UK general population remains low.
- Both clades of mpox (clade I and clade II) are no longer classified as a high consequence infectious disease (HCID) in the UK, as of March 2025.
Situation in the US
- The first case of clade Ib mpox detected in the US was reported on 16 November 2024. The infection was diagnosed in a person in California who recently traveled to the US from Eastern Africa.
- Three more cases have been reported since then (as of 1 April 2025). All cases were in people who had recently traveled to affected areas in Central and Eastern Africa, and the cases were not linked.
- The wider risk to the US general population remains low.
It is unclear at this time whether disease caused by the clade Ib variant differs from that of the clade II variant that caused the ongoing 2022 global outbreak, or whether current vaccines are effective against the new variant. However, the clinical presentation of clade Ib mpox appears to be similar to the signs and symptoms reported in the global clade II mpox outbreak, and differs from clade I outbreaks elsewhere in Africa.
Updated information on the situation is available from public health authorities.
This is the second time the WHO has declared an mpox outbreak to be a PHEIC, with the first one declared in July 2022 due to a global outbreak in countries that had not previously experienced cases. This outbreak was due to the clade IIb variant. The emergency was declared over in May 2023 as the number of cases had decreased significantly since their peak in August 2022. However, clade II mpox is still circulating globally with outbreaks in many countries.
Several outbreaks of mpox caused by different clades of the virus have occurred in different countries, with different modes of transmission and levels of risk. Outbreaks are ongoing in some countries. Mpox was first detected in humans in the DRC in 1970, and is endemic to countries in Central and West Africa.
Dapagliflozin approved by FDA for treatment of type 2 diabetes in children
The sodium-glucose cotransporter-2 (SGLT2) inhibitor dapagliflozin has been approved by the Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type 2 diabetes ages 10 years and older. Prior to this, dapagliflozin was approved only in adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control.
The approval in pediatric patients was based on results from T2NOW, one of the largest pediatric type 2 diabetes phase 3 trials to date. Data demonstrated a significant reduction in hemoglobin A1c (HbA1c) for patients treated with dapagliflozin compared with patients receiving placebo.The safety results in this patient population were consistent with those in adults with type 2 diabetes.
Dapagliflozin has also received approval from the European Medicines Agency (EMA) for use in children ages ≥10 years with uncontrolled type 2 diabetes as an adjunct to diet and exercise.
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