IPC issues Safety warning against use of common painkiller Meftal

India: The Indian Pharmacopoeia Commission (IPC) has recently issued a drug safety alert on the common painkiller Meftal. The IPC is an autonomous institution of the Ministry of Health that sets standards for all drugs that are manufactured, sold, and consumed in India.

The IPC has advised consumers and healthcare professionals (HCPs) to exercise caution concerning the potential adverse drug reaction (ADR) linked to the use of Mefenamic acid, the constituent of Meftal. 

A preliminary analysis of ADRs from the database of the Pharmacovigilance Programme of India has revealed cases of Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome, which affects internal organs. These symptoms may appear 2-8 weeks after taking the drug.

“The IPC has advised healthcare professionals, patients/consumers to closely monitor the possibility of the above adverse drug reaction associated with the use of the suspected drug,” stated the alert, issued on 30 November.

The alert further stated, “If such a reaction is encountered, people should report the matter to the national coordination centre of the PvPI under the commission by filling a form on the website — www.ipc.gov.in — or through the Android mobile app ADR PvPI, as well as PvPI helpline number 1800-180-3024.”

DRESS syndrome, also known as Drug-Induced Hypersensitivity Syndrome (DIHS), is a severe allergic reaction affecting around 10% of individuals, potentially deadly and caused by certain medications. It is characterized by high fever, skin rash, swollen lymph nodes and complications in internal organs.

The key features of DRESS syndrome are:

· Skin Rash: Patients with DRESS often develop a widespread rash that can involve various body parts. The rash may be maculopapular (flat and raised lesions), erythematous (red), and may resemble other skin conditions.

· Internal Organ Involvement: DRESS can affect multiple organs, including the liver, kidneys, lungs, and heart. This can lead to hepatitis, nephritis, pneumonitis, and myocarditis.

· Fever: Individuals with DRESS typically experience a high fever.

· Lymphadenopathy: Swollen lymph nodes (lymphadenopathy) are common in DRESS.

· Haematologic Abnormalities: Blood abnormalities, such as atypical lymphocytes, eosinophilia (elevated eosinophil count), and other hematologic changes, may be present.

Use and Associated Side Effects of Meftal

Meftal is used commonly as a non-steroidal anti-inflammatory drug (NSAID). It is indicated for the treatment of osteoarthritis, rheumatoid arthritis, dysmenorrhoea, mild to moderate pain, fever, inflammation, and dental pain.

Although the drug is not available over the counter (OTC) and requires a prescription for purchase, it is extensively used in India for various purposes such as relieving headaches, menstrual pain, and muscle and joint pain, and is even prevalent among children for high fever.

Prolonged use of Meftal is reported to increase the risk of stomach ulcers, bleeding, and related complications. It has been associated with potential adverse effects on the cardiovascular system. Some experts have flagged renal complications as a potential side effect of Meftal.

If someone suspects DRESS or experiences symptoms after taking a medication, it is important to seek prompt medical attention. DRESS is a medical emergency, and early recognition and intervention are required for a better prognosis. Consultation with healthcare professionals is recommended for accurate diagnosis and appropriate management.

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Body dissatisfaction in late childhood tied to risk of depression by age 14: Lancet

UK: Findings from a recent longitudinal study published in The Lancet Psychiatry suggest that greater body dissatisfaction in late childhood is an important risk factor for depression during adolescence, irrespective of the child’s body mass index (BMI). 

“Body dissatisfaction at age 11 is linked to increased risk of depression by age 14,” UCL researchers report. The findings show that body image concerns explain a large proportion of an association between BMI and depression in children, particularly in girls.

The study, supported by Wellcome, involved 13,135 participants of the Millennium Cohort Study, a UCL-led nationally representative birth cohort study of people born between 2000 and 2002.

The researchers found that high BMI at age seven was linked with increased depressive symptoms (which can include low mood, loss of pleasure and poor concentration) by age 14, as well as with greater body dissatisfaction at age 11.

They found that body dissatisfaction was a major contributor to the link between BMI at age seven and subsequent depressive symptoms, explaining 43% of the association.

All three of these associations were twice as large in girls compared to boys.

Lead author Dr Francesca Solmi (UCL Psychiatry) said: “Depression has become more common among young people, as have having an overweight BMI, and body dissatisfaction.

“Here we have found strong longitudinal evidence that a high BMI in childhood is linked with an increased risk of depressive symptoms multiple years later.

“But we were particularly interested in how much body dissatisfaction might be the driver of this link. We found strong evidence that being unhappy with one’s appearance is linked with increased depressive symptoms years later. Our findings suggest that any efforts to reduce weight in childhood need to consider their potential mental health impacts, so that we can avoid stigmatising weight and instead support children’s mental health and wellbeing.”

The research did not cover what other factors, besides body dissatisfaction, could explain why children with high BMI are more likely to develop depressive symptoms, but they say that other biological (for instance inflammation) or environmental (for instance bullying) pathways might explain part of the association.

First author Emma Blundell, trainee clinical psychologist at UCL Psychology & Language Sciences, said: “Many public health strategies seek to reduce weight in childhood. Primary school children are being taught about the importance of calories and exercise, and all young people in England are being weighed at school to determine whether weight loss efforts are needed. Whilst promoting healthy diet and exercise is important, it may be that some public health messaging could be fostering feelings of guilt or shame.

“It is important to ensure that any interventions to reduce BMI in childhood do not inadvertently increase body dissatisfaction and harm children’s mental health.”

The researchers say that some strategies to target body image concerns in early adolescence have been developed, such as with psychological interventions or media literacy training that could address self-esteem, social comparisons, and social media influences, but more research is needed to more effectively tackle body image concerns in young people.

Dr Solmi added: “Reducing body dissatisfaction in young people could be an important way of preventing depression, particularly in girls, at ages when social environments and peer relations become increasingly impactful.”

Reference:

Emma Blundell, Prof Bianca L De Stavola, Madelaine Davies Kellock, Gemma Lewis, Prof Anne McMunn, Longitudinal pathways between childhood BMI, body dissatisfaction, and adolescent depression: an observational study using the UK Millenium Cohort Study, DOI:https://doi.org/10.1016/S2215-0366(23)00365-6.

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Early Pharmacological Treatment of Type II SMA Patients Slows Scoliosis Progression

A recent study has shed new light on the potential impact of early pharmacological interventions on scoliosis progression in individuals with Type II spinal muscular atrophy (SMA). Scoliosis, affecting up to 90% of Type II SMA cases, poses a significant challenge, and while treatments have shown improvements in motor function, their effect on scoliosis remains uncertain. This study was published in the Journal Of Neurology Neurosurgery and Psychiatry by Giorgia Coratti and colleagues.

The study aimed to investigate differences in scoliosis progression between treated and untreated Type II SMA patients. Researchers analyzed the effect of treatment on Cobb’s angle annual changes and the likelihood of reaching a critical 50° Cobb angle in patients with a minimum 1.5-year follow-up. The study utilized a sliding cut-off approach to identify the optimal treatment subpopulation based on age, initial Cobb angle, and Hammersmith Functional Motor Scale Expanded at the initial visit. The Mann-Whitney U-test assessed statistical significance.

Comparing a cohort of 46 untreated individuals with 39 treated patients, the study initially found no significant differences in baseline characteristics. However, when analyzing the impact of pharmacological treatment on scoliosis progression, intriguing patterns emerged. The mean Cobb angle variation did not significantly differ between the treated and untreated groups initially. Yet, upon exploring optimal cut-off values for a better outcome, the treated group, especially those with a Cobb angle <26° or an age <4.5 years, demonstrated a significantly lower mean Cobb angle variation. The treated group showed a lower mean Cobb variation compared to the untreated group (5.61 (SD 4.72) degrees/year vs 10.05 (SD 6.38) degrees/year; p=0.01). Furthermore, Cox-regression analysis indicated a protective effect of treatment in preventing patients from reaching a 50° Cobb angle, particularly pronounced in patients younger than 4.5 years old (p=0.016).

The study’s results underscore a potential correlation between early pharmacological treatment initiation and slowed scoliosis progression in Type II SMA patients. These findings emphasize the importance of early intervention, particularly in individuals under 4.5 years old or those with a lower initial Cobb angle, suggesting a more favorable response to treatment. However, researchers caution that larger-scale studies are imperative to delve deeper into the efficacy of individual pharmacological treatments on scoliosis progression in this patient population.

Reference:

Coratti, G., Lenkowicz, J., Pera, M. C., D’Amico, A., Bruno, C., Gullì, C., Brolatti, N., Pedemonte, M., Antonaci, L., Ricci, M., Capasso, A., Cicala, G., Cutrona, C., de Sanctis, R., Carnicella, S., Forcina, N., Cateruccia, M., Damasio, M. B., Labianca, L., … Mercuri, E. Early treatment of type II SMA slows rate of progression of scoliosis. Journal of Neurology, Neurosurgery, and Psychiatry,2023, jnnp-2023-332084. https://doi.org/10.1136/jnnp-2023-332084

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Dapagliflozin may improve symptoms in patients with HFrEF with limited impact on exercise capacity

Dapagliflozin may improve symptoms in patients with HFrEF with limited impact on exercise capacity suggests a new study published in the Circulation.

Sodium-glucose cotransporter 2 inhibitors reduce the risk of worsening heart failure (HF) and cardiovascular death in patients with HF irrespective of left ventricular ejection fraction. It is important to determine whether therapies for HF improve symptoms and functional capacity.

The DETERMINE (Dapagliflozin Effect on Exercise Capacity Using a 6-Minute Walk Test in Patients With Heart Failure) double-blind, placebo-controlled, multicenter trials assessed the efficacy of the sodium-glucose cotransporter 2 inhibitor dapagliflozin on the Total Symptom Score (TSS) and Physical Limitation Scale (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6-minute walk distance (6MWD) in 313 patients with HF with reduced ejection fraction (DETERMINE-Reduced) and in 504 patients with HF with preserved ejection fraction (DETERMINE-Preserved) with New York Heart Association class II or III symptoms and elevated natriuretic peptide levels. The primary outcomes were changes in the KCCQ-TSS, KCCQ-PLS, and 6MWD after 16 weeks of treatment.

RESULTS:

Among the 313 randomized patients with HF with reduced ejection fraction, the median placebo-corrected difference in KCCQ-TSS from baseline at 16 weeks was 4.23 (95% CI, 0.96, 8.22; P=0.022) in favor of dapagliflozin. The median placebo-corrected difference in KCCQ-PLS was 4.2 (95% CI, 0.00, 8.3; P=0.058). The median placebo-corrected difference in 6MWD from baseline at 16 weeks was 3.2 meters (95% CI, −6.5, 13.0; P=0.69). In the 504 patients with HF with preserved ejection fraction, the median placebo-corrected 16-week difference in KCCQ-TSS and KCCQ-PLS was 3.2 (95% CI, 0.4, 6.0; P=0.079) and 3.1 (−0.1, 5.4; P=0.23), respectively. The median 16-week difference in 6MWD was 1.6 meters (95% CI, −5.9, 9.0; P=0.67). In an exploratory post hoc analysis of both trials combined (DETERMINE-Pooled), the median placebo-corrected difference from baseline at 16 weeks was 3.7 (1.5, 5.9; P=0.005) for KCCQ-TSS, 4.0 (0.3, 4.9; P=0.036) for KCCQ-PLS, and 2.5 meters (−3.5, 8.4; P=0.50) for 6MWD.

Dapagliflozin improved the KCCQ-TSS in patients with HF with reduced ejection fraction but did not improve KCCQ-PLS or 6MWD. Dapagliflozin did not improve these outcomes in patients with HF with preserved ejection fraction. In a post hoc analysis including all patients across the full spectrum of ejection fraction, there was a beneficial effect of dapagliflozin on KCCQ-TSS and KCCQ-PLS but not 6MWD.

Reference:

Effect of Dapagliflozin Versus Placebo on Symptoms and 6-Minute Walk Distance in Patients With Heart Failure: The DETERMINE Randomized Clinical Trials

John J.V. McMurray, Kieran F. Docherty, Rudolf A. de Boer, Ann Hammarstedt, Dalane W. Kitzman, Mikhail N. Kosiborod, Anna Maria Langkilde, Barry Reicher, Michele Senni, Sanjiv J. Shah, Ulrica Wilderäng, Subodh Verma and Scott D. Solomon

Originally published 7 Dec 2023https://doi.org/10.1161/CIRCULATIONAHA.123.065061Circulation. 2023;0

Keywords:

Dapagliflozin, improve, symptoms, patients, HFrEF, limited, impact, exercise, capacity,John J.V. McMurray, Kieran F. Docherty, Rudolf A. de Boer, Ann Hammarstedt, Dalane W. Kitzman, Mikhail N. Kosiborod, Anna Maria Langkilde, Barry Reicher, Michele Senni, Sanjiv J. Shah, Ulrica Wilderäng, Subodh Verma and Scott D. Solomon

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New AI tool predicts post-surgery mortality

USA: The researchers at the Smidt Heart Institute at Cedars-Sinai and colleagues at two other institutions have developed an artificial intelligence (AI) tool that accurately predicts how patients would fare after surgeries and procedures. The results, published in The Lancet Digital Health, include data from patients from three healthcare systems: Cedars-Sinai, Stanford University and Columbia University.

All patients in the study underwent a surgical procedure, including open heart surgery, other major surgeries, and minimally invasive procedures involving a catheter or endoscope.

Investigators trained an AI model on pre-operative electrocardiograms, discovering a new use for the 130-year-old test. Invented in the late-1800s, an electrocardiogram is a commonly deployed test that involves placing electrodes on the skin to measure the heart’s electrical activity and assess how well the heart is functioning.

“This is the first electrocardiogram-based AI algorithm that predicts post-operative mortality,” said David Ouyang, MD, a cardiologist in the Department of Cardiology in the Smidt Heart Institute at Cedars-Sinai, and a corresponding author of the study. “Previously, algorithms have been used to assess long-term mortality as well as individual disease states, but determining post-surgical outcomes helps inform the actual decision to do surgery.”

Investigators paired patients’ electrocardiograms from before the surgery or procedure, with their outcomes after the surgery or procedure, and asked the algorithm to find associations or patterns in the electrocardiogram waveforms.

While classifying most patients as low risk, those individuals the algorithm identified as high risk had nearly a 9-fold increased probability of post-operative mortality.

“As it now stands, clinicians only have a modest ability to predict how a patient is going to do after surgery,” said Ouyang, also a faculty member in the Division of Artificial Intelligence in Medicine at Cedars-Sinai. “Current clinical risk prediction tools are insufficient. This AI model could potentially be used to determine exactly which patients should undergo an intervention and which patients might be too sick.”

Every medical intervention comes with risk, and doctors currently rely on guidelines from medical societies to determine a patient’s individual risk.

“In cardiology, we’re fortunate to have many life-saving procedures, everything from catheter-based procedures to open-heart surgery, so we’re often trying to think about who are the right patients for the right procedure,” said Christine M. Albert, MD, MPH, chair of the Department of Cardiology in the Smidt Heart Institute and the other corresponding author of the study. “A better understanding of risk, particularly by using a commonly obtained diagnostic test, can inform important medical decisions.”

Investigators are currently studying how the algorithm could be translated into a web application that would be widely available for physicians and patients.

Reference:

David Ouyang, John Theurer, Nathan R Stein, J Weston Hughes, Pierre Elias, Bryan He, Electrocardiographic deep learning for predicting post-procedural mortality: a model development and validation study, DOI:https://doi.org/10.1016/S2589-7500(23)00220-0.

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Lupin gets CDSCO Panel nod for Rifapentine Dispersible Tablet 150 mg

New Delhi: Granting the local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved drug major Lupin’s Rifapentine dispersible Tablets 150mg for already approved indication with the condition of conducting a Phase IV Clinical study.

This came after the firm presented their proposal for a grant of permission to manufacture and marketing of Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) for an already approved indication along with the bioequivalence study report before the committee.

Rifapentine is an antitubercular agent and a leprostatic drug. Rifapentine is an antibacterial prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of active tuberculosis (TB) of the lungs. (Active TB is also called TB disease.) Rifapentine is also FDA-approved for the treatment of latent TB infection to prevent the infection from advancing to active TB disease.

It inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

Rifapentine is used with other medications to treat active tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body) in adults and children 12 years of age and older.

At the recent SEC meeting for Antimicrobial and Antiviral held on 29th November 2023, the expert panel reviewed the proposal for grant of permission to manufacture and marketing of Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) for an already approved indication along with the Bioequivalence study report presented by drug major Lupin.

After detailed deliberation, the committee recommended for approval of Rifapentine Dispersible Tablets 150mg for an already approved indication with a local clinical trial waiver with a condition to conduct a Phase IV Clinical study.

Accordingly, the expert panel suggested that the firm should submit a Phase IV protocol to CDSCO within 3 months of approval for further evaluation by the committee.

In addition, the committee stated that the firm should fulfill the requirements of CMC (chemistry, manufacturing, and controls) data before approval of the product.

Also Read: AstraZeneca gets CDSCO panel Nod to study anti-cancer drug Volrustomig in women with cervical cancer

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Consumption of Fresh vegetables has potential benefit of improving eGFR among elderly

Diet rich in Fresh vegetables has potential benefit of improving eGFR among elderly suggests a new study published in the BMC Nephrology.

This study aimed to investigate the relationship between the consumption of fresh and salt-preserved vegetables and the estimated glomerular filtration rate (eGFR), which requires further research.

The prevalence of chronic kidney disease (CKD) generally increases with age owing to nephron loss and a decline in the glomerular filtration rate (GFR). The estimated GFR (eGFR) assumes a widely recognized role as a marker that plays a pivotal role in evaluating overall kidney health and diagnosing various renal disorders.

For this purpose, the data of those subjects who participated in the 2011–2012 and 2014 surveys of the Chinese Longitudinal Healthy Longevity Survey (CLHLS) and had biomarker data were selected. Fresh and salt-preserved vegetable consumptions were assessed at each wave. eGFR was assessed using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on plasma creatinine. Furthermore, a linear mixed model was used to evaluate associations between fresh/salt-preserved vegetables and eGFR.

Results

The results indicated that the median baseline and follow-up eGFRs were 72.47 mL/min/1.73 m² and 70.26 mL/min/1.73 m², respectively. After applying adjusted linear mixed model analysis to the data, the results revealed that compared to almost daily intake, occasional consumption of fresh vegetables was associated with a lower eGFR (β=-2.23, 95% CI: -4.23, -0.23). Moreover, rare or no consumption of salt-preserved vegetables was associated with a higher eGFR (β = 1.87, 95% CI: 0.12, 3.63) compared to individuals who consumed salt-preserved vegetables daily.

Fresh vegetable consumption was direct, whereas intake of salt-preserved vegetables was inversely associated with eGFR among the oldest subjects, supporting the potential benefits of diet-rich fresh vegetables for improving eGFR.

Reference:

Zheng, H., Li, H., Pan, L. et al. Association of fresh vegetable and salt-preserved vegetable consumptions with estimated glomerular filtration rate. BMC Nephrol 24, 369 (2023). https://doi.org/10.1186/s12882-023-03353-5

Keywords:

Diet, rich, Fresh, vegetable, potential, benefit, of, improving, eGFR, among, elderly, BMC Neph8rology, Zheng, H., Li, H., Pan, L

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Conduct BE study and clinical trial: CDSCO Panel tells Cipla on Formoterol Fumarate Dihydrate, glycopyrronium inhaler

New Delhi: Rejecting the proposal for clinical trial and bioequivalence (BE) study waiver presented by drug major Cipla, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the BE study of the fixed-dose combination Formoterol Fumarate Dihydrate plus Glycopyrronium inhaler with innovator product as a reference product.

In addition, the expert panel rejected the clinical trial waiver at this stage.

This came after the drug major Cipla presented their proposal along with justification for clinical trial and bioequivalence (BE) study waiver before the committee.

Formoterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Formoterol is an inhaled beta2-agonist used in the management of Chronic Obstructive Pulmonary Disease (COPD) and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways and is administered as a racemic mixture of its active (R; R)- and inactive (S;S)-enantiomers.

Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

At the recent SEC meeting for Pulmonary held on 5th December 2023, the expert panel reviewed the proposal presented by the drug major Cipla along with the justification for clinical trial (CT) and BE waiver before the committee.

After detailed deliberation, the committee recommended that the firm conduct the BE study with the innovator product as a reference product, and the clinical trial waiver was not considered at this stage.

Accordingly, the expert panel suggested that the BE protocol should be presented before the committee for review.

Also Read: Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDC

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New guidelines released for treatment of anaphylaxis and atopic dermatitis

Two new practice parameters from the Joint Task Force for Practice Parameters (JTFPP) offer evidence-based recommendations for the diagnosis and management of anaphylaxis and atopic dermatitis (AD) in pediatric and adult patients. The Joint Task Force is a partnership between the American College of Allergy, Asthma and Immunology (ACAAI) and the American Academy of Allergy, Asthma and Immunology.

“Both anaphylaxis and atopic dermatitis are allergic conditions that affect millions of people-in the United States and around the world,” says allergist Jay Lieberman, MD, co-chair of the JTFPP Task Force. “We regularly update our practice parameters to make sure allergists and other healthcare practitioners are aware of best practices when diagnosing and managing these disorders. When physicians and their staffs are aware of updated guidance, it means patients are getting the best, most appropriate care.”

Anaphylaxis

“The 2023 JTFPP anaphylaxis practice parameter provides evidence-based recommendations to support optimal contextual care across contemporary practice settings,” says allergist David B.K. Golden, MDCM, lead author of the practice parameter. “With important new guidance related to diagnostic evaluation, anaphylaxis in infants and in community settings, epinephrine treatment, mast cell conditions, beta-blockers and ACE inhibitors, and peri-operative anaphylaxis, these guidelines translate recent advances in the understanding of severe allergic reactions to help all healthcare professionals provide individualized care to each patient at the right time, in the right place, every time.”

The practice parameter on anaphylaxis focuses on areas where new evidence has emerged, and recommendations have evolved.

Key anaphylaxis guideline highlights include:

  • Updates on recommendations regarding if a patient must go to the emergency room if they use epinephrine for anaphylaxis. Calling emergency services (EMS) after use of an epinephrine auto injector (EAI) may not be required if the patient experiences prompt, complete, and durable response to treatment and has access to additional EAIs. Situations that would warrant EMS activation include severe anaphylaxis, symptoms that do not resolve promptly, completely or nearly completely, or symptoms that return or worsen.
  • Recommendations on how, where and by whom epinephrine auto injectors should be stored.
  • Updates on the diagnosis of anaphylaxis. Revised criteria by the World Allergy Organization (WAO), Brighton, and Delphi Consensus groups aim to create more universally accepted definitions and criteria for anaphylactic reactions.
  • Updates on how to recognize and treat anaphylaxis in infants. Diagnosing anaphylaxis in infants and toddlers can be challenging, and there are no age-specific anaphylaxis diagnostic criteria. Therefore, the current National Institute of Allergy and Infectious Diseases/Food Allergy & Anaphylaxis Network or World Allergy Organization anaphylaxis criteria should be used to establish the diagnosis of anaphylaxis in infants/toddlers.
  • Updates on how to evaluate and treat anaphylaxis in relation to a surgery.
  • Updates on nuances regarding the use of beta-blockers and ACE inhibitors in patients at risk for anaphylaxis.

Atopic Dermatitis

“The 2023 JTFPP atopic dermatitis guideline represents an advancement in trustworthy allergy guidelines,” says allergist Derek Chu, M.D., Ph.D. “It is distinguished from other guidelines through systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to GRADE – a rigorous guideline development process, as well as the involvement of the patient and caregiver voice from start to finish. Clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation were paramount. The guidelines emphasize, in addition to standards of trustworthiness, the third principle of evidence-based medicine: that evidence alone is never enough; that patient values and preferences are crucial to arriving at optimal recommendations. The new recommendations also reflect the evolution of diversity, equity and inclusion in approaching diagnosis and management of this condition.”

Key atopic dermatitis guideline highlights include:

  • Recommends the use of topical corticosteroids or topical calcineurin inhibitors in patients with uncontrolled AD, despite moisturizers.
  • Highlights the safety of the topical calcineurin inhibitors with typical usage once or twice daily.
  • Recommends proactive therapy with topical corticosteroids or topical calcineurin inhibitors for patients with a relapsing course.
  • Consideration for once daily dosing of topical medications. Recommends dupilumab for patients 6 months of age or older with moderate-severe AD refractory, intolerant, or unable to use mid-potency topical treatment, or tralokinumab for similar patients ages 12 years and older.
  • Suggests against elimination diets for AD.
  • Suggests the usage of crisaborole 2% ointment for mild to moderate atopic dermatitis.
  • Suggests against the use of topical antibiotics for AD alone with no infection.
  • Suggests bleach baths for AD patients with moderate to severe disease as an additive therapy; suggests against use for mild AD.
  • Suggests consideration of allergen immunotherapy for moderate to severe AD.
  • Suggests use of oral JAK inhibitors after careful consideration of risks and benefits in adults and adolescents with moderate-severe AD refractory, intolerant, or unable to use mid to high potency topical treatment and biologics.
  • Suggests against immunosuppressant medications such as baricitinib (a JAK inhibitor), azathioprine, methotrexate and, mycophenylate mofetil
  • Suggests consideration of cyclosporin in adults and adolescents with moderate-severe AD refractory, intolerant, or unable to use mid to high potency topical treatment and biologics.
  • Suggests against the use of systemic corticosteroids for AD.

The practice parameters are published in Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma & Immunology.

Reference:

Golden DBK, Wang J, Waserman S, Akin C, Campbell RL, Ellis AK, Greenhawt M, Lang DM, Ledford DK, Lieberman J, Oppenheimer J, Shaker MS, Wallace DV, Abrams EM, Bernstein JA, Chu DK, Horner CC, Rank MA, Stukus DR; Collaborators; Burrows AG, Cruickshank H; Workgroup Contributors; Golden DBK, Wang J, Akin C, Campbell RL, Ellis AK, Greenhawt M, Lang DM, Ledford DK, Lieberman J, Oppenheimer J, Shaker MS, Wallace DV, Waserman S; Joint Task Force on Practice Parameters Reviewers; Abrams EM, Bernstein JA, Chu DK, Ellis AK, Golden DBK, Greenhawt M, Horner CC, Ledford DK, Lieberman J, Rank MA, Shaker MS, Stukus DR, Wang J. Anaphylaxis: A 2023 practice parameter update. Ann Allergy Asthma Immunol. 2023 Dec 5:S1081-1206(23)01304-2. doi: 10.1016/j.anai.2023.09.015.

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Shweta Rai appointed as MD of Bayer Zydus Pharma

Bayer has announced that Shweta Rai will take over as Managing Director of Bayer Zydus Pharma Private Limited and Country Division Head (CDH) for Bayer’s Pharmaceuticals Business in South Asia effective, January 1, 2024. Manoj Saxena will move out of his present role to take on the role of CDH for Bayer’s Pharmaceuticals Division and Senior Bayer Representative, Bayer Group for the Australia & New Zealand (ANZ) cluster, with effect from the same date.

For more details, check out the link given below:

Shweta Rai Takes Over As MD Of Bayer Zydus Pharma

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