Clinical News: February 2024

February 28, 2024

Your monthly source for drug information highlights

Clinical News

Your monthly source for drug information highlights

Hot topics

WEIGHT MANAGEMENT MEDICATION DEMONSTRATES BLOOD PRESSURE REDUCTION

A study published in Hypertension found a significant reduction in systolic blood pressure (SBP) in patients taking tirzepatide (Zepbound™). This substudy of the SURMOUNT-1 trial included data from 600 adults with obesity without type 2 diabetes mellitus (T2DM) and with blood pressure < 140/90 mmHg. Patients were randomized to placebo or once weekly Zepbound at varying doses (5 mg, 10 mg, and 15 mg). SBP was measured by 24-hour ambulatory blood pressure monitoring. Participants enrolled were an average age of 45.5 years with an average body mass index (BMI) of 37.4 kg/m2. At baseline, 30% of participants had hypertension, and 29% were using ≥ 1 antihypertensive medication; the average 24-hour SBP was 124.6 mmHg. After 36 weeks, participants had an average SBP reduction from baseline of 7.4 mmHg with the 5 mg dose, 10.6 mmHg with the 10 mg dose, and 8 mmHg with the 15 mg dose. Reductions were seen in both day and nighttime SBP. Zepbound is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist (RA) indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥ 30 kg/m2 (obesity) or ≥ 27 kg/m2 (overweight) in the presence of ≥ 1 weight-related comorbid condition (e.g., hypertension, dyslipidemia, T2DM, obstructive sleep apnea, cardiovascular [CV] disease).

Data from the American Heart Association (AHA)’s 2024 Heart Disease and Stroke Statistics demonstrate > 47% of adults in the U.S. have hypertension, and almost 42% of adults have obesity. The annual report developed by AHA in conjunction with the National Institutes of Health (NIH) also provides statistics related to heart disease, stroke, and CV risk factors, including core health behaviors (smoking, physical activity, nutrition, sleep, and obesity) and health factors (cholesterol, blood pressure, glucose control, and metabolic syndrome) that contribute to CV health.

More trending topics

BEHAVIORAL HEALTH CORNER

Results from the 2022 National Survey on Drug Use and Health (NSDUH) by SAMHSA have been released. Overall, 59.3 million U.S. adults (23.1%) were found to have any mental illness (e.g., mental, behavioral, or emotional disorder) in the past year. The prevalence was highest among young adults 18 to 25 years of age (36.2%), followed by adults 26 to 49 years of age (29.4%); adults ≥ 50 years of age had the lowest rates (13.9%). In 2022, 17.3% of individuals ≥ 12 years of age had a substance use disorder (SUD) in the past year, including alcohol use disorder (AUD), drug use disorder (DUD), or both AUD and a DUD. Additional details are provided on use of mental health services, prevalence of serious mental illness, and mental disorders in adolescents.

Shortages of stimulants for ADHD are currently being reported by the FDA. This includes generic methylphenidate extended-release as well as generic lisdexamfetamine dimesylate capsules and chewable tablets.

WEIGHT MANAGEMENT CORNER

The FDA is currently reporting shortages of GLP-1 RAs that are indicated for select patients as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management. This includes liraglutide (Saxenda®) which is on shortage due to increased demand. Novo Nordisk has announced an increase in the supply of starter doses of semaglutide (Wegovy®). There will be a doubling of the supply of starter doses and gradual increases in overall supply throughout 2024.

Shortages are also being reported for GLP-1 RAs that are indicated for select patients with T2DM. Liraglutide (Victoza®) has limited availability through March 2024. The FDA is reporting limited availability of dulaglutide (Trulicity®) 1.5 mg/0.5 mL injection through March 2024 due to increased demand; all other strengths are available. Additionally, tirzepatide (Mounjaro®; a dual GIP receptor and GLP-1 RA) in the strengths of 10 mg/0.5 mL, 12.5 mg/0.5 mL, and 15 mg/0.5 mL has limited availability until early March 2024 due to increased demand. Mounjaro 2.5 mg/0.5 mL, 5 mg/0.5 mL, and 7.5 mg/0.5 mL strengths remain available.

CLINICAL CORNER

The FDA has issued safety labeling change notification letters to the manufacturers of all FDA-approved B-cell maturation antigen (BCMA)-directed and cluster of differentiation (CD)19-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapies. This includes the following agents: idecabtagene vicleucel (Abecma®), lisocabtagene maraleucel (Breyanzi®), ciltacabtagene autoleucel (Carvykti®), tisagenlecleucel (Kymriah®), brexucabtagene autoleucel (Tecartus®), and axicabtagene ciloleucel (Yescarta®). The letter requires revision to the labeling for these products due to the risk of T-cell malignancies, with serious outcomes, including the potential for hospitalization and death. The safety labeling change notification letter follows the FDA’s November 2023 safety communication issued on the potential for T-cell malignancy observed with these agents. The December 2023 edition of the Clinical News provides additional details on this safety communication.

COVID-19: NOTABLE DEVELOPMENTS

The FDA announced a revision to the nirmatrelvir tablets/ritonavir tablets’ (Paxlovid™) EUA to state that product manufactured and labeled in alignment with the EUA (EUA-labeled Paxlovid) currently available in the U.S. will continue to be authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. After March 8, 2024, EUA-labeled Paxlovid will not be authorized for emergency use regardless of the labeled or extended expiration date, but the Paxlovid EUA will continue to allow for emergency use of Paxlovid manufactured/labeled in alignment with the NDA (NDA-labeled Paxlovid).

The CDC published an MMWR on early estimates of vaccine effectiveness for the updated 2023-2024 COVID formula against symptomatic infection caused by co-circulating Omicron variants in immunocompetent adults. Receiving an updated COVID vaccine provided about 54% increased protection against symptomatic SARS-CoV-2 infection compared to not receiving an updated vaccine. Protection was provided against JN.1 as well as other circulating lineages. As of February 17, 2024, data from the CDC demonstrate that the JN.1 (Omicron) variant is responsible for an estimated 96.4% of COVID cases in the U.S.

Results from the Assessing the Safety of Pregnancy During the Coronavirus Pandemic (ASPIRE) study were published in JAMA Pediatrics, with data suggesting COVID vaccination during pregnancy had no negative impact on the neurodevelopment of infants up to 18 months of age. The prospective cohort study was conducted from May 2020 to August 2021 and enrolled 2,487 pregnant participants at < 10 weeks’ gestation. Neurodevelopmental assessments were completed remotely by the mothers at 12 and 18 months, using established cutoffs in 5 subdomains (communication, gross motor, fine motor, problem solving, and social skills); 30.6% of exposed infants and 28.2% of unexposed infants screened abnormally for developmental delay at 12 months (p=0.25); at 18 months, 20.1% and 23.2% (p=0.13) of infants, respectively, screened abnormally for developmental delay. Researchers concluded longer-term evaluation is needed to confirm findings.

INFLUENZA UPDATES

The CDC is reporting influenza-like illness (ILI) for the week ending February 17, 2024 (week 7). Seasonal influenza activity remains elevated in the U.S. with increases seen in some regions. The most frequently reported influenza viruses this week were A(H1N1). As of February 5, 2024, the FDA is reporting available product from all manufacturers of antiviral influenza medications.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on March 5, 2024 to discuss and make recommendations for selection of strains to include in 20242025 influenza vaccines.

BEHAVIORAL HEALTH CORNER

Results from the 2022 National Survey on Drug Use and Health (NSDUH) by SAMHSA have been released. Overall, 59.3 million U.S. adults (23.1%) were found to have any mental illness (e.g., mental, behavioral, or emotional disorder) in the past year. The prevalence was highest among young adults 18 to 25 years of age (36.2%), followed by adults 26 to 49 years of age (29.4%); adults ≥ 50 years of age had the lowest rates (13.9%). In 2022, 17.3% of individuals ≥ 12 years of age had a substance use disorder (SUD) in the past year, including alcohol use disorder (AUD), drug use disorder (DUD), or both AUD and a DUD. Additional details are provided on use of mental health services, prevalence of serious mental illness, and mental disorders in adolescents.

Shortages of stimulants for ADHD are currently being reported by the FDA. This includes generic methylphenidate extended-release as well as generic lisdexamfetamine dimesylate capsules and chewable tablets.

WEIGHT MANAGEMENT CORNER

The FDA is currently reporting shortages of GLP-1 RAs that are indicated for select patients as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management. This includes liraglutide (Saxenda®) which is on shortage due to increased demand. Novo Nordisk has announced an increase in the supply of starter doses of semaglutide (Wegovy®). There will be a doubling of the supply of starter doses and gradual increases in overall supply throughout 2024.

Shortages are also being reported for GLP-1 RAs that are indicated for select patients with T2DM. Liraglutide (Victoza®) has limited availability through March 2024. The FDA is reporting limited availability of dulaglutide (Trulicity®) 1.5 mg/0.5 mL injection through March 2024 due to increased demand; all other strengths are available. Additionally, tirzepatide (Mounjaro®; a dual GIP receptor and GLP-1 RA) in the strengths of 10 mg/0.5 mL, 12.5 mg/0.5 mL, and 15 mg/0.5 mL has limited availability until early March 2024 due to increased demand. Mounjaro 2.5 mg/0.5 mL, 5 mg/0.5 mL, and 7.5 mg/0.5 mL strengths remain available.

CLINICAL CORNER

The FDA has issued safety labeling change notification letters to the manufacturers of all FDA-approved B-cell maturation antigen (BCMA)-directed and cluster of differentiation (CD)19-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapies. This includes the following agents: idecabtagene vicleucel (Abecma®), lisocabtagene maraleucel (Breyanzi®), ciltacabtagene autoleucel (Carvykti®), tisagenlecleucel (Kymriah®), brexucabtagene autoleucel (Tecartus®), and axicabtagene ciloleucel (Yescarta®). The letter requires revision to the labeling for these products due to the risk of T-cell malignancies, with serious outcomes, including the potential for hospitalization and death. The safety labeling change notification letter follows the FDA’s November 2023 safety communication issued on the potential for T-cell malignancy observed with these agents. The December 2023 edition of the Clinical News provides additional details on this safety communication.

COVID-19: NOTABLE DEVELOPMENTS

The FDA announced a revision to the nirmatrelvir tablets/ritonavir tablets’ (Paxlovid™) EUA to state that product manufactured and labeled in alignment with the EUA (EUA-labeled Paxlovid) currently available in the U.S. will continue to be authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. After March 8, 2024, EUA-labeled Paxlovid will not be authorized for emergency use regardless of the labeled or extended expiration date, but the Paxlovid EUA will continue to allow for emergency use of Paxlovid manufactured/labeled in alignment with the NDA (NDA-labeled Paxlovid).

The CDC published an MMWR on early estimates of vaccine effectiveness for the updated 2023-2024 COVID formula against symptomatic infection caused by co-circulating Omicron variants in immunocompetent adults. Receiving an updated COVID vaccine provided about 54% increased protection against symptomatic SARS-CoV-2 infection compared to not receiving an updated vaccine. Protection was provided against JN.1 as well as other circulating lineages. As of February 17, 2024, data from the CDC demonstrate that the JN.1 (Omicron) variant is responsible for an estimated 96.4% of COVID cases in the U.S.

Results from the Assessing the Safety of Pregnancy During the Coronavirus Pandemic (ASPIRE) study were published in JAMA Pediatrics, with data suggesting COVID vaccination during pregnancy had no negative impact on the neurodevelopment of infants up to 18 months of age. The prospective cohort study was conducted from May 2020 to August 2021 and enrolled 2,487 pregnant participants at < 10 weeks’ gestation. Neurodevelopmental assessments were completed remotely by the mothers at 12 and 18 months, using established cutoffs in 5 subdomains (communication, gross motor, fine motor, problem solving, and social skills); 30.6% of exposed infants and 28.2% of unexposed infants screened abnormally for developmental delay at 12 months (p=0.25); at 18 months, 20.1% and 23.2% (p=0.13) of infants, respectively, screened abnormally for developmental delay. Researchers concluded longer-term evaluation is needed to confirm findings.

INFLUENZA UPDATES

The CDC is reporting influenza-like illness (ILI) for the week ending February 17, 2024 (week 7). Seasonal influenza activity remains elevated in the U.S. with increases seen in some regions. The most frequently reported influenza viruses this week were A(H1N1). As of February 5, 2024, the FDA is reporting available product from all manufacturers of antiviral influenza medications.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on March 5, 2024 to discuss and make recommendations for selection of strains to include in 20242025 influenza vaccines.

Drug information happenings & highlights

DRUG INFORMATION HIGHLIGHTS

SUPPLY CHAIN

  • EDW Pharma announced a shortage of the 50 mg/10 mL oral suspension of riluzole (Tiglutik®) as manufacturing was interrupted due to viscosity testing; therefore, the FDA is allowing for temporary importation of a 5 mg/1 mL oral suspension of riluzole.
  • Manufacturers of erythromycin ophthalmic ointment are reporting a shortage of the product. The CDC has published an alternative regimen for preventing gonococcal ophthalmia neonatorum.
  • The FDA released a communication warning patients to avoid purchasing or using the following copycat eye drop products due to the potential for eye infection: South Moon, Rebright, or FivFivGo. These products may easily be mistaken for Bausch + Lomb’s brimonidine tartrate (Lumify®) product, approved for OTC use. The copycat eye drops are not approved drugs and should not be marketed in the U.S.; these products claim to treat eye conditions, including glaucoma. Consumers are recommended to purchase eye products only from reputable retailers (e.g., state-licensed pharmacies).
  • Kilitch Healthcare India amended the press release from November 13, 2023 to correct NDC numbers for lubricant eye drops. Product was distributed across the U.S. to wholesalers, retailers, and via the product distributor, Velocity Pharma.
  • Insight has voluntarily recalled two lots of the OTC product Ting® 1% Tolnaftate Athlete’s Foot Spray to the consumer level due to elevated levels of benzene in the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting® Antifungal Spray products and is classified as a human carcinogen.
  • Following FDA request, Emergent extended the shelf-life of newly produced naloxone hydrochloride (Narcan®) 4 mg nasal spray to 4 years (previously 3 years). The extension is only applicable to products manufactured after the date of the announcement (January 17, 2024). Product previously manufactured is not impacted and maintains the same shelf-life printed on the product’s packaging.

DRUG INFORMATION HAPPENINGS

  • On February 2, 2024, the Department of Health and Human Services released a final rule regarding opioid treatment program (OTP) accreditation, certification, and standards for the treatment of opioid use disorder (OUD) with medications for OUD in OTPs.
  • The American Academy of Dermatology (AAD) released updated guidelines for the management of acne vulgaris. The guidelines provide evidence-based recommendations and good practice statements.
  • The American College of Gastroenterology (ACG) published a clinical guideline on alcohol-associated liver disease. Currently, corticosteroids are the only treatment modality with demonstrated efficacy in severe alcohol-associated hepatitis; at 1 month, these agents provide a survival benefit in 50% to 60% of patients.
  • The American Dental Association (ADA) published updated guidelines for management of acute dental pain in adolescents, adults, and older adults. NSAIDs with or without acetaminophen likely provide superior pain management with a better safety profile than opioids.
  • The American Gastroenterological Association (AGA) published a clinical practice guideline on the management of pouchitis and inflammatory pouch disorders. The guidelines include conditional recommendations that address the use of various therapies ranging from antibiotics and probiotics to advanced immunosuppressive therapies (e.g., biologics and/or oral small molecule drugs), and corticosteroids.

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care provider.

Glossary of terms

ADHD = attention deficit hyperactivity disorder

CDC = Centers for Disease Control and Prevention

EUA = Emergency Use Authorization

JAMA = Journal of the American Medical Association

MMWR = Morbidity and Mortality Weekly Report

NDA = New Drug Application

NDC = National Drug Code

NSAIDS = nonsteroidal anti-inflammatory drugs

OTC = over the counter

SAMHSA = Substance Abuse and Mental Health Services Administration

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

Editorial team

EDITOR-IN-CHIEF: Maryam Tabatabai, PharmD

EXECUTIVE EDITOR: Anna Schreck Bird, PharmD

DEPUTY EDITORS: Erik Hamel, PharmD; Olivia Pane, PharmD, CDCES

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