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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 5 | Issue 12
July 15, 2023

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Medications for the Treatment of Pediatric Type 2 Diabetes

On June 20, 2023, the U.S. Food and Drug Administration (FDA) expanded the approved age range for Jardiance® (empagliflozin) and Synjardy® (empagliflozin and metformin hydrochloride), two medications used in the treatment of type 2 diabetes,  to include patients as young as 10. These oral medications belong to a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors that remove excess glucose from the blood by enhancing its excretion in the urine. Both medications were previously approved to treat type 2 diabetes in adult patients, as well as to reduce the risk of cardiovascular death and hospitalization in patients with cardiovascular disease or heart failure. In a study of patients ages 10-17 with type 2 diabetes, empagliflozin showed a greater reduction in hemoglobin A1C and fasting blood sugar compared to placebo. Increased risk of low blood sugar was the most common side effect reported throughout this trial. In the United States, there has been a steady increase in the rate of cases of pediatric patients with type 2 diabetes. Based on the current trend, it is estimated that there could be up to 220,000 cases by 2060. This expanded age range approval is very important in increasing the number or treatment options for pediatric patients with type 2 diabetes. Previously, metformin and insulin were the only approved treatment options for children. 

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Drug Safety

Walnut Thermometer Recall Due to the Potential for Skin Burns

A voluntary recall of BearCare’s Walnut Wearable Smart Thermometer, known as the Walnut Thermometer, was announced on May 10, 2023. This thermometer is used for continuous chest temperature monitoring in pediatric patients up to 6 years old. The over-the-counter product was sold online through Walmart, Amazon and the manufacturer’s website, between December 2022 and April 2023. The product can be identified by the silicone exterior that resembles a cartoon penguin. The recall was prompted by reports of minor to severe skin burns and irritation. A device that is at risk of failing may feel warm to the touch and show corrosion near the smart sensor on the back of the device. It could also demonstrate diminished battery life, a substance leaking from the device or issues connecting with the associated Walnut app. BearCare, Inc. has advised consumers to discontinue use of this product and take caution if there are traces of moisture leaking from the device. Parents are advised to inspect all areas of the body for burns or chemical toxicity. Health care providers should be contacted in the event of exposure to leaking fluid. Consumers may contact to return their thermometer and obtain a full refund. Adverse reactions should be reported to the FDA’s MedWatch Adverse Event Reporting program.

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From the Pharmaceutical Industry

CDC Recommends RSV Vaccine for Adults 60 and Older

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has recommended that adults 60 years and older receive a single dose of one of the newly approved vaccines for the prevention of Respiratory Syncytial Virus (RSV) infection. RSV is a respiratory virus that can have serious consequences for infants and older adults. It may lead to lung infections, pneumonia, hospitalization or death. Individuals with weakened immune systems or chronic heart or lung disease are at the highest risk for severe RSV infections. GSK’s Arexy and Pfizer’s Abrysvo™ are the first FDA-approved RSV vaccines, expected to become available for the Fall 2023 vaccination season. Cases of RSV tend to spike in the winter months, so administration this fall will help to decrease risk and increase protection from RSV. Individuals should discuss this vaccine with their health care providers, along with additional vaccines to prevent from the spread of respiratory infections.

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FDA Approvals

New FDA Approvals

New Drug: Litfulo™ (ritlecitinib) 

Oral capsules approved for the treatment of severe localized hair loss in adults and adolescent patients 12 years and older. [06/23/2023 – PFIZER INC]              

New Drug: Roctavian™ (valoctocogene roxaparvovec-rvox) 

Intravenous injection approved for the treatment of adult patients with severe hemophilia A. [06/29/2023 – BioMarin Pharmaceutical Inc.]