1
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.
2
In Brief: Severe Hypocalcemia with Denosumab (Prolia) in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen), a monoclonal
antibody that inhibits osteoclasts, about an
increased risk of severe hypocalcemia in patients
with advanced chronic kidney disease (CKD;
eGFR <30 mL/min/1.73 m2), particularly those on
dialysis. FDA-approved indications for Prolia are
listed in Table 1.
3
Drugs for Menopausal Symptoms
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The primary symptoms of menopause are genitourinary
and vasomotor. The genitourinary syndrome
of menopause (GSM) includes symptoms such as
burning, irritation, dryness, dyspareunia, dysuria,
and recurrent urinary tract infection. Vasomotor
symptoms (VMS; hot flashes, night sweats) often
disrupt sleep.
4
In Brief: A New OTC Naloxone Nasal Spray (RiVive)
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has approved RiVive (Harm Reduction
Therapeutics), a 3-mg naloxone nasal spray, as
an over-the-counter (OTC) product for emergency
treatment of opioid overdose. Two 4-mg naloxone
nasal spray formulations, Narcan and one of its
generics, were approved for OTC sale in 2023.
5
Tenapanor (Xphozah) for Hyperphosphatemia in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The FDA has approved the sodium/hydrogen
exchanger 3 (NHE3) inhibitor tenapanor (Xphozah –
Ardelyx) to reduce serum phosphorus in adults with
chronic kidney disease (CKD) on dialysis as add-on
therapy when phosphate binders are ineffective or
as monotherapy when phosphate binders cannot be
tolerated. Tenapanor is the first NHE3 inhibitor to be
approved in the US for hyperphosphatemia. It was
previously approved as Ibsrela to treat irritable bowel
syndrome with constipation (IBS-C).
6
Airsupra: An Inhaled Albuterol/Budesonide Combination for Asthma
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has approved Airsupra (AstraZeneca), a
metered-dose inhaler containing the short-acting
beta2-agonist (SABA) albuterol and the inhaled
corticosteroid (ICS) budesonide, for use as needed for
treatment or prevention of bronchoconstriction and to
reduce the risk of exacerbations in patients ≥18 years
old with asthma. Airsupra is the first combination of
a SABA and an ICS to become available in the US. It is
not approved for use as maintenance therapy.
7
Penbraya: A Pentavalent Meningococcal Vaccine
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has licensed Penbraya (Pfizer), a pentavalent
polysaccharide conjugate meningococcal
vaccine, for prevention of invasive meningococcal
disease caused by Neisseria meningitidis
serogroups A, B, C, W, or Y (MenABCWY) in persons
10-25 years old. Penbraya is the only meningococcal
vaccine that contains all five of these serogroups.
Two quadrivalent polysaccharide conjugate
meningococcal vaccines containing serogroups A,
C, W, and Y (MenACWY; Menveo, MenQuadfi) and
two meningococcal serogroup B vaccines (MenB;
Bexsero, Trumenba) are available in the US (see
Table 2).
8
Mirikizumab (Omvoh) for Ulcerative Colitis
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has approved the interleukin (IL)-23
antagonist mirikizumab-mrkz (Omvoh – Lilly) for
treatment of moderately to severely active ulcerative
colitis (UC) in adults. Mirikizumab is the first selective
IL-23 antagonist to be approved for this indication.
Ustekinumab (Stelara), an IL-12/23 antagonist, was
approved for treatment of UC in 2019. The IL-23
antagonist risankizumab (Skyrizi) is approved for
treatment of Crohn's disease.
9
In Brief: Fexofenadine (Allegra) and Fruit Juice
The Medical Letter on Drugs and Therapeutics • May 30, 2011; (Issue 1365)
Fexofenadine (Allegra, and others) is the most recent second-generation H1-antihistamine to become available over the counter (OTC). Cetirizine (Zyrtec, and others) and loratadine (Claritin, and others) are already available OTC. Cetirizine can be sedating in usual doses. Loratadine can be sedating in higher-than-usual doses. Fexofenadine remains nonsedating even in higher doses.
10
Comparison Chart: SGLT2 Inhibitors (online only)
The Medical Letter on Drugs and Therapeutics • November 16, 2020; (Issue 1611)
View the Comparison Chart: SGLT2 Inhibitors