1
In Brief: New FDA Warning of Pulmonary Aspiration with GLP-1 Receptor Agonists
The Medical Letter on Drugs and Therapeutics • December 23, 2024; (Issue 1718)
The package inserts of the GLP-1 receptor agonists
dulaglutide (Trulicity), exenatide (Byetta, Bydureon
BCise), liraglutide (Saxenda, Victoza), and semaglutide
(Ozempic, Rybelsus, Wegovy) and the dual glucosedependent
insulinotropic polypeptide (GIP)/GLP-1
receptor agonist tirzepatide (Mounjaro, Zepbound)
have been updated to include rare postmarketing
reports of pulmonary aspiration associated with their
use in patients undergoing elective surgery or other
procedures requiring general anesthesia or deep
sedation who had residual gastric contents despite
preoperative fasting.
2
In Brief: Alternatives to Adderall
The Medical Letter on Drugs and Therapeutics • November 28, 2022; (Issue 1664)
The short-acting formulation of mixed amphetamine
salts (Adderall, and generics) FDA-approved for
treatment of attention-deficit hyperactivity disorder
(ADHD) and narcolepsy, is currently in short supply in
the US. Until an adequate supply is restored, patients
may be looking for alternatives.
3
Antiviral Drugs for Seasonal Influenza for 2024-2025
The Medical Letter on Drugs and Therapeutics • December 9, 2024; (Issue 1717)
Influenza is generally a self-limited illness, but
pneumonia, respiratory failure, and death can occur,
especially in persons at increased risk for influenza
complications (see Table 1). Updated information on
influenza activity and antiviral resistance is available
from the CDC at cdc.gov/flu.
4
In Brief: OTC Ivermectin for Head Lice
The Medical Letter on Drugs and Therapeutics • June 26, 2023; (Issue 1679)
Topical ivermectin lotion 0.5% (Sklice, and generics),
which has been available by prescription since 2012,
is now FDA-approved for sale over the counter (OTC)
for treatment of head lice in patients ≥6 months old.
Ivermectin is also available by prescription as a 1%
cream (Soolantra) approved for topical treatment of
inflammatory lesions of rosacea and in oral tablets
(Stromectol, and generics) for treatment of various
parasitic infections.
5
In Brief: Femlyv – An Orally Disintegrating Hormonal Contraceptive
The Medical Letter on Drugs and Therapeutics • December 9, 2024; (Issue 1717)
Femlyv (Millicent), an orally disintegrating tablet
containing ethinyl estradiol and norethindrone
acetate, has been approved by the FDA for prevention
of pregnancy in females with a body mass index (BMI)
≤35 kg/m2. It is the first hormonal contraceptive to
become available in an orally disintegrating tablet
formulation. Traditional oral and chewable tablets
containing ethinyl estradiol and norethindrone acetate
in a wide range of doses, including those found in
Femlyv, have been available in the US for years.
6
Comparison Chart: Antiviral Drugs for Seasonal Influenza for 2024-2025 (online only)
The Medical Letter on Drugs and Therapeutics • December 9, 2024; (Issue 1717)
View the Comparison Chart: Antiviral Drugs for Seasonal Influenza for 2024-2025
7
Capvaxive – A 21-Valent Pneumococcal Conjugate Vaccine
The Medical Letter on Drugs and Therapeutics • October 14, 2024; (Issue 1713)
The FDA has licensed Capvaxive (PCV21; Merck),
a 21-valent pneumococcal conjugate vaccine, for
prevention of invasive pneumococcal disease (IPD)
and pneumococcal pneumonia in adults. Four other
pneumococcal vaccines are currently available in the
US: Prevnar 20 (PCV20), Vaxneuvance (PCV15), and
Prevnar 13 (PCV13) are conjugate vaccines licensed
for use in persons ≥6 weeks old, and Pneumovax 23
(PPSV23) is a pneumococcal polysaccharide vaccine
licensed for use in persons ≥2 years old (see Table 1).
8
Isatuximab (Sarclisa) for Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • December 9, 2024; (Issue 1717)
Isatuximab-irfc (Sarclisa – Sanofi), a CD38-directed
cytolytic antibody, has been approved by the FDA for
treatment of newly diagnosed multiple myeloma in
adults who are not eligible for autologous stem cell
transplantation (ASCT). The drug was approved earlier
for treatment of relapsed or treatment-refractory
multiple myeloma.
9
Marstacimab (Hympavzi) for Hemophilia A and B
The Medical Letter on Drugs and Therapeutics • December 9, 2024; (Issue 1717)
Marstacimab-hncq (Hympavzi – Pfizer), a tissue
factor pathway inhibitor (TFPI) antagonist, has been
approved by the FDA for routine prophylaxis to prevent
or reduce the frequency of bleeding episodes in patients
≥12 years old who have hemophilia A without factor VIII
inhibitors or hemophilia B without factor IX inhibitors.
It is the first hemophilia treatment to be approved in
the US that targets an inhibitor of coagulation and the
first to become available in prefilled pens and syringes
for subcutaneous administration.
10
Zolbetuximab (Vyloy) for Gastric and Gastroesophageal Carcinoma (online only)
The Medical Letter on Drugs and Therapeutics • December 9, 2024; (Issue 1717)
Zolbetuximab-clzb (Vyloy – Astellas), a claudin
18.2 (CLDN18.2)-directed cytolytic antibody, has
been approved by the FDA for use in combination
with fluoropyrimidine- and platinum-containing
chemotherapy for first-line treatment of locally
advanced unresectable or metastatic human epidermal
growth factor receptor 2 (HER2)-negative gastric or
gastroesophageal junction (GEJ) adenocarcinoma in
patients who have CLDN18.2-positive tumors. It is the
first monoclonal antibody to be approved in the US
that selectively targets CLDN18.2.