1
COVID-19 Update: New Pfizer and Moderna Vaccine Formulations for 2023-2024
The Medical Letter on Drugs and Therapeutics • September 18, 2023; (Issue 5067)
New 2023-2024 formulations of the mRNA COVID-19
vaccines manufactured by Pfizer/BioNTech
(Comirnaty) and that more
closely target currently circulating variants have
been licensed by the FDA for use in persons ≥12 years
old and made available under FDA Emergency Use
Authorizations (EUAs) for use in persons 6 months
to 11 years old. The bivalent (original and Omicron
BA.4/5) formulations of the Pfizer and Moderna
vaccines are no longer authorized for use in the US.
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
Drugs for Opioid Use Disorder
The Medical Letter on Drugs and Therapeutics • September 4, 2023; (Issue 1684)
Opioid use disorder is a chronic, relapsing disease with
physical and psychiatric components. It is associated
with economic hardship, social isolation, incarceration,
increased rates of blood-borne infections such as HIV
and viral hepatitis, adverse pregnancy outcomes, and
increased mortality. According to the NIH, there were
80,411 deaths involving an opioid in the US in 2021,
more than in any previous year. Several guidelines on
the management of opioid use disorder are available;
all recommend maintenance pharmacotherapy as the
standard of care.
4
Nirsevimab (Beyfortus) for Prevention of Severe RSV Disease in Young Children
The Medical Letter on Drugs and Therapeutics • September 18, 2023; (Issue 1685)
The FDA has approved nirsevimab-alip (Beyfortus –
AstraZeneca/Sanofi), a long-acting monoclonal
antibody, for the prevention of respiratory syncytial
virus (RSV) lower respiratory tract disease in
neonates and infants born during or entering their
first RSV season, and in children ≤24 months old who
are at increased risk for severe RSV disease through
their second RSV season. Nirsevimab is the first drug
to be approved for protection of all infants during
their first RSV season.
5
Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder (online only)
The Medical Letter on Drugs and Therapeutics • September 4, 2023; (Issue 1684)
View Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder
6
Suflave — A Low-Volume Colonoscopy Preparation
The Medical Letter on Drugs and Therapeutics • September 18, 2023; (Issue 1685)
The FDA has approved Suflave (Sebela/Braintree), a
low-volume polyethylene glycol (PEG)- and sulfate-based
product for cleansing of the colon prior to
colonoscopy in adults. Other oral colonoscopy
preparations available in the US are listed in
Table 2. Suflave is marketed as tasting better than
other products.
7
Opill — An OTC Oral Contraceptive
The Medical Letter on Drugs and Therapeutics • September 18, 2023; (Issue 1685)
The FDA has approved Opill (Perrigo), a progestin-only
oral contraceptive that contains norgestrel, for
sale over the counter (OTC). Opill is the first oral
contraceptive to be approved in the US for sale without
a prescription. Approval of OTC Opill is intended
to increase access to effective contraception and
reduce the rate of unintended pregnancies.
8
Two Vaccines (Arexvy and Abrysvo) for Prevention of RSV Disease
The Medical Letter on Drugs and Therapeutics • October 2, 2023; (Issue 1686)
Two recombinant vaccines, Arexvy (GSK) and
Abrysvo (Pfizer), have been approved by the FDA for
prevention of lower respiratory tract disease (LRTD)
caused by respiratory syncytial virus (RSV) in adults
≥60 years old. They are the first RSV vaccines to be
approved in the US. Abrysvo is also approved for
use in pregnant women at 32-36 weeks' gestation
to prevent LRTD caused by RSV in their infants from
birth through 6 months of age.
9
Addendum: Gabapentinoids and Renal Impairment
The Medical Letter on Drugs and Therapeutics • October 2, 2023; (Issue 1686)
A nephrologist and longtime reader of The Medical Letter
wrote us to say that our recent article entitled Drugs for
Anxiety Disorders should have said more about the need
for dosage adjustment of gabapentin (Neurontin, and
others) and pregabalin (Lyrica, and others) in patients
with renal impairment. Both drugs, he pointed out, are
exclusively renally eliminated and can accumulate in
patients with diminished renal function. Symptoms,
which can include altered mental status, may develop
so slowly that neither the patient nor the practitioner
connect them to the drug. The resolution of adverse
effects upon discontinuation can be slow.
10
Addendum: Over-the-Counter Narcan Nasal Spray
The Medical Letter on Drugs and Therapeutics • October 2, 2023; (Issue 1686)
Since the publication of our articles entitled Drugs for
Opioid Use Disorder and In Brief: Over-the-Counter
Narcan Nasal Spray earlier this year, Narcan (Emergent),
a nasal spray that delivers 4 mg of the opioid antagonist
naloxone, has become available for sale over the counter
(OTC). According to the manufacturer, the retail price for
a box containing 2 doses is $44.99. Some insurance
companies have announced plans to cover OTC
purchase of the drug for their members.