Clinical Highlights: February 2025

Publications

Your monthly source for drug information highlights.

February 28, 2025

The annual report Cancer statistics, 2025 from the American Cancer Society (ACS) detailing cancer trends has been published. Cancer is the leading cause of death in persons < 85 years of age and the second leading cause of death in the United States (U.S.) overall. In 2025, it is estimated there will be 2,041,910 new cancer diagnoses and 618,120 cancer deaths in the U.S. Although the cancer mortality rate decreased by 34% from 1991 to 2022, this was offset by an increasing incidence for various cancers, especially in women and younger adults. Death rates are rising for cancers of the oral cavity, pancreas, uterine corpus and liver (female). Pancreatic cancer is the third leading cause of cancer death; the incidence and mortality rates for this cancer are increasing with a five-year survival rate of only 8% for the vast majority of patients with pancreatic exocrine tumors. The incidence of cancer is higher in women 50 to 64 years of age compared with men of the same age range, and in women < 50 years of age the incidence rate is 82% higher than men of the same age. The rate of new cases for colorectal cancer in persons < 65 years of age and cervical cancer in women 30 to 44 years of age has also increased. Inequalities in cancer related deaths continue to occur, with Native American individuals having two to three times higher mortality rates than White individuals for kidney, liver, stomach and cervical cancers. Similarly, the cancer mortality rate is twice as high for Black individuals than White individuals for prostate, stomach and uterine corpus cancers. Although the cancer rate in children ≤ 14 years of age has decreased, the rate has continued to increase among adolescents 15 to 19 years of age. Since the 1970s, mortality rates in children and adolescents have declined by 70% and 63%, respectively, due in large part to better treatments for leukemia. As overall cancer mortality has declined, there have been increased cases in middle-aged and young adults, particularly women, as well as certain racial and ethnic groups. Additional efforts and research are needed to curtail these rising mortality rates in certain patient populations.

JAMA Otolaryngology-Head & Neck Surgery has published results from a prespecified secondary analysis of a target trial emulation from a comparative effectiveness study (n=351,913) suggesting an association between glucagon-like peptide-1 (GLP-1) receptor agonist initiation and an increased risk of thyroid cancer diagnosis compared to other diabetes medications. The study was based on claims data for commercial, Medicare and Medicare Advantage plans in the U.S. and included adults with type 2 diabetes mellitus (T2DM) at moderate risk for cardiovascular (CV) disease and without a history of thyroid cancer. Those analyzed had newly filled prescriptions for a GLP-1 receptor agonist, sodium-glucose cotransporter 2 inhibitor (SGLT2i), dipeptidyl peptidase-4 inhibitor (DPP4i) or sulfonylurea (SU) from Jan. 1, 2014, to Dec. 31, 2021. The absolute risk of thyroid cancer diagnosis was low overall (GLP-1: n=69, 0.17%; DPP4i: n=172, 0.23%; SGLT2i: n=72, 0.17%; SU: n=381, 0.2%), and in the modified intention-to-treat (mITT) analysis, GLP-1 initiation was not associated with an overall higher risk for thyroid cancer compared to the other diabetes medications (hazard ratio [HR], 1.24; 95% confidence interval [CI], 0.88 to 1.76). However, within the first year after GLP-1 initiation, the risk for thyroid cancer was significantly higher (HR, 1.85; 95% CI, 1.11 to 3.08) compared to the other classes of diabetes medications and was even greater in the overall as-treated analysis, which censored patients when therapy was discontinued or another drug was added (HR, 2.07; 95% CI, 1.1 to 3.95). Additional research is needed to further assess this potential association as the finding may have been related to enhanced early detection in patients receiving GLP-1s.

Novo Nordisk has announced topline results from the Phase 3b STEP UP trial (n=1,407). The study is a randomized, double-blinded, parallel-group, placebo-controlled, superiority 72-week trial evaluating adults with obesity (body mass index [BMI] ≥ 30 kg/m²) without diabetes. Results if all patients were adherent to treatment demonstrated from a mean baseline body weight of 113 kg that treatment with semaglutide 7.2 mg subcutaneous (SC) weekly (non-Food and Drug Administration [FDA] approved dose) led to 20.7% weight loss from baseline compared with 17.5% weight loss with semaglutide 2.4 mg SC weekly and 2.4% weight loss with placebo. All patients received lifestyle intervention. The primary endpoint, evaluated at week 72, was reached with statistically superior weight loss being observed with semaglutide 7.2 mg SC weekly compared to placebo. A second 72-week trial (STEP UP T2D) is underway evaluating semaglutide 7.2 mg in 512 adults with obesity and T2DM; results from this study are expected in the coming months.

Shortage updates

The U.S. FDA has provided an update on the shortages of Novo Nordisk’s semaglutide products (Ozempic, Wegovy) and states the shortages have resolved; however, there could still be intermittent and local supply disruptions as product progresses through the supply chain. To avoid disruptions in patient care, the agency does not intend to act against compounders for violations of the Federal Food, Drug & Cosmetic (FD&C) Act within the following grace periods. State-licensed pharmacies or physician compounding under section 503A of the FD&C Act are permitted to compound, distribute or dispense semaglutide injections until April 22, 2025, and 503B outsourcing facilities are permitted to compound, distribute or dispense semaglutide injections until May 22, 2025. The agency may still take action against substandard quality or unsafe products. Novo Nordisk’s liraglutide (Saxenda) for weight management has limited availability, as does the liraglutide (Victoza) formulation indicated for select patients with T2DM; an authorized generic of Victoza distributed by Teva is available.

The FDA is allowing for temporary importation of unapproved tafenoquine succinate (Kodatef) from Australia due to the shortage of FDA-approved tafenoquine (Arakoda). Arakoda is an antimalarial indicated for the prophylaxis of malaria in patients ≥ 18 years of age. The temporary shortage of FDA-approved Arakoda is due to a delay in completing commercial validation for updated packaging formats. Unapproved Kodatef has the same active ingredient, dosage and indication for use as Arakoda. Kodatef will be available through Infuserve America, a specialty pharmacy distributor. Arakoda is expected to return to availability by April 1, 2025.

Shortages of stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) continue to be reported. Availability of generic methylphenidate hydrochloride (HCl) extended-release (ER) tablets is variable depending on the manufacturer. Brand name Relexxii from Vertical, as well as brand name Concerta from Janssen, are currently available. Generic amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate immediate release (IR) tablet shortages are also being reported; most strengths of brand-name Adderall IR tablets from Teva are available. Shortages of the generic version of Vyvanse, lisdexamfetamine dimesylate capsules and chewable tablets persist. Brand name Vyvanse capsules and chewable tablets remain available from Takeda.

The FDA is reporting limited availability of peginterferon alfa-2a (Pegasys) 180 mcg/0.5 mL and 180 mcg/1 mL injections due to shortage of an active ingredient. Availability is anticipated to be more limited through the fourth quarter of 2025 with product replenishment prior to May 31, 2026. Pegasys is indicated for select pediatric and adult patients with chronic hepatitis B or C.

Drug information highlights

Pfizer has announced discontinuation of the one-time single-dose gene therapy fidanacogene elaparvovec-dzkt (Beqvez). Approved in April 2024, the product is indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who (1) currently use factor IX prophylaxis therapy, or (2) have current or historical life-threatening hemorrhage, or (3) have repeated, serious spontaneous bleeding episodes, and, do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.
The FDA has issued a safety alert regarding concerns with diabetes devices (e.g., continuous glucose monitors, insulin pumps, automated insulin dosing systems) that use a smartphone to deliver safety alerts. Users have reported the alerts are not being delivered or not being heard, missing crucial alerts may have led to serious patient harm (e.g., severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, death). The FDA has also published recommendations to users of these devices to mitigate these risks.

Alvogen has voluntarily recalled one lot of fentanyl transdermal system 25 mcg/hr patches to the consumer level. The recall is due to the potential for patches to be multi-stacked or adhered one on top of the other in a single product pouch. Application of a multi-stacked 25 mcg/hr patch could lead to serious, life-threatening or fatal respiratory depression; those who are potentially at increased risk include first-time recipients of these patches as well as children and the elderly.

The U.S. Centers for Disease Control and Prevention (CDC) is reporting influenza-like illness (ILI) for the week ending Feb. 15, 2025 (week seven). Seasonal influenza activity continues to be increased. As of early February, activity was reported as being higher than it had been all season, and the season was classified as a high severity season overall and for all age groups. This is the first time since the 2017 to 2018 season that levels have reached high severity. Influenza A(H1N1)pdm09 and A(H3N2) viruses continue to co-circulate. As of Feb. 10, 2025, the FDA is reporting available product from most manufacturers of antiviral medications.

The Advisory Committee on Immunization Practices (ACIP) recommended 2025 immunization schedules for children and adolescents (aged ≤ 18 years) and for adults (aged ≥ 19 years) have been published in the Morbidity and Mortality Weekly Report (MMWR). Updates from the 2024 schedule for ages ≤ 18 years include new and updated recommendations for coronavirus disease 2019 (COVID-19) vaccines, Haemophilus influenzae type b vaccines, influenza vaccines and meningococcal serogroup B vaccines. For adults, new and updated recommendations for the COVID-19 vaccine, influenza vaccines, meningococcal serogroup B vaccines, pneumococcal conjugate vaccines and respiratory syncytial virus vaccines are provided. For both the pediatric and adult immunization schedules, the recommended influenza vaccines are trivalent formulations (previously quadrivalent)

The FDA has released a safety communication to increase awareness of updates to the prescribing information of capecitabine and fluorouracil (5-FU); these updates are regarding risks associated with use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Health care professionals (HCPs) should consider testing for DPD deficiency before starting these medications as use is not recommended in patients with complete DPD deficiency due to the potential for serious and life-threatening adverse reactions (e.g., mucositis, diarrhea, neutropenia, neurotoxicity). Patients with partial DPD deficiency may also have an increased risk of these serious and potentially fatal events.
The FDA has provided an update to an alert posted in 2020 regarding the risk of medication errors with tranexamic acid injection leading to inadvertent intrathecal (spinal) injection. The agency has continued to receive reports of tranexamic acid being mistakenly injected intrathecally instead of the intended intrathecal anesthetic (e.g., bupivacaine); this has caused severe patient outcomes (e.g., prolonged hospitalization, disability, death). A safety evaluation is ongoing, and the FDA plans to provide additional communication regarding results as well as potential items of action.

Drug information happenings

The American College of Physicians (ACP) has released a clinical practice guideline on use of pharmacological treatment for prevention of episodic migraine, defined as one to 14 headache days per month. Recommendations for initiation of monotherapy for prevention in nonpregnant adults in outpatient settings are detailed, as well as alternative options if initial therapies are not tolerated or provide insufficient relief.
The Alzheimer's Association and Society for Nuclear Medicine and Molecular Imaging have released updated appropriate use criteria (AUC) for amyloid positron emission tomography (PET) and new AUC for tau PET. The intent is to assist HCPs in identifying scenarios in which PET imaging may be helpful in the diagnosis and management of patients with or at risk for cognitive decline.
The Alzheimer's Association has published a special issue that highlights the new Diagnostic Evaluation, Testing, Counseling and Disclosure of suspected Alzheimer's Disease and Related Disorders (DETeCD-ADRD) Clinical Practice Guideline and provides guidance on the integration of biomarkers into the patient assessment process. The guideline includes patients with Lewy body disease, frontotemporal lobar degeneration, vascular cognitive impairment and dementia, and other diseases/conditions that may result in or contribute to cognitive-behavioral impairment.
The American College of Gastroenterology (ACG) published updated clinical guidelines for the diagnosis and management of eosinophilic esophagitis (EoE), a chronic immune-mediated disease of the esophagus. Recommendations are provided for diagnosis, treatment, monitoring and assessment of response; pediatric considerations are also detailed.
Updated National Institute for Health and Care Excellence (NICE) guidelines have been published on the prevention and management of central adiposity, overweight and obesity for children, young persons and adults. These guidelines replace other prior guidance from NICE on obesity and weight management.
The American Society of Clinical Oncology (ASCO) has updated its guidelines on neoadjuvant chemotherapy and primary cytoreductive surgery for newly diagnosed, advanced ovarian cancer. Recommendations are provided for patients with stage III to IV epithelial ovarian, fallopian tube or primary peritoneal cancer.

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.

All brand names are property of their respective owners.

Editor-In-Chief: Maryam Tabatabai, PharmD
Executive Editor: Anna Schreck Bird, PharmD
Deputy Editors: Erik Hamel, PharmD; Olivia Pane, PharmD, CDCES

About us

Corporate social responsibility

Solutions overview

Modern technology

Drug access

Clinical solutions

Condition management

Specialty drug management

Government solutions

Single-state programs

Read

Watch

Listen

Home Delivery

Specialty Pharmacy

Navigate to

Back

Back

Back

Back