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In Brief: New Warnings on NSAID Use in Pregnancy
The Medical Letter on Drugs and Therapeutics • Nov 02, 2020 (Issue 1610)
impairment.1
NSAID labels previously warned against use of the drugs
beginning at 30 weeks’ gestation ...
The FDA has required a new warning in the labels of
prescription and over-the-counter products containing
nonsteroidal anti-inflammatory drugs (NSAIDs) advising
against their use during pregnancy beginning at 20
weeks’ gestation because of a risk of renal dysfunction
in the fetus that could lead to low amniotic fluid levels
(oligohydramnios) and neonatal renal impairment.
NSAID labels previously warned against use of the drugs
beginning at 30 weeks' gestation because of a risk for
premature closure of the ductus arteriosus and persistent
neonatal pulmonary hypertension
Lyumjev - A New Insulin Lispro for Diabetes
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020 (Issue 1609)
–
Lilly), a faster-acting formulation of insulin lispro
(Humalog), for treatment of type 1 and type 2 ...
The FDA has approved insulin lispro-aabc (Lyumjev –
Lilly), a faster-acting formulation of insulin lispro
(Humalog), for treatment of type 1 and type 2 diabetes
in adults. Fiasp, a faster-acting formulation of insulin
aspart (Novolog), was approved in 2017.
Timing of Remdesivir for COVID-19
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020 (Issue 1609)
hospitalized with severe disease.1
MECHANISM OF ACTION — Remdesivir is a nucleotide
prodrug of an adenosine ...
Remdesivir (Veklury – Gilead), an investigational
antiviral drug administered by IV infusion, is now
available through an FDA Emergency Use Authorization
(EUA) for treatment of COVID-19 in all hospitalized
patients. An earlier EUA limited use of the drug to
patients hospitalized with severe disease.
Caplacizumab (Cablivi) for iTTP
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020 (Issue 1609)
purpura (iTTP; formerly called
acquired thrombotic thrombocytopenic purpura
[aTTP]) in adults.1 ...
Caplacizumab-yhdp (Cablivi – Sanofi /Genzyme), a
von Willebrand factor-directed antibody fragment, has
been approved by the FDA for use in combination with
plasma exchange and immunosuppressive therapy
for treatment of immune-mediated thrombotic
thrombocytopenic purpura (iTTP; formerly called
acquired thrombotic thrombocytopenic purpura
[aTTP]) in adults. It is the first drug to be approved in
the US for this indication.
Sublingual Apomorphine (Kynmobi) for Parkinson's Disease
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020 (Issue 1609)
of apomorphine
(Apokyn) has been available for years for the same
indication in patients with advanced PD.1 ...
The FDA has approved a sublingual fi lm formulation
of the nonergot dopamine agonist apomorphine
(Kynmobi – Sunovion) for acute, intermittent treatment
of "off" episodes in patients with Parkinson's disease
(PD). A subcutaneous formulation of apomorphine
(Apokyn) has been available for years for the same
indication in patients with advanced PD.
Viltolarsen (Viltepso) for Duchenne Muscular Dystrophy
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020 (Issue 1609)
oligonucleotide golodirsen
(Vyondys 53) was approved in 2019.1
Pronunciation Key
Viltolarsen: vil” toe lar’ sen ...
The antisense oligonucleotide viltolarsen (Viltepso –
NS Pharma) has received accelerated approval
from the FDA for treatment of Duchenne muscular
dystrophy (DMD) in patients who have mutations of the
dystrophin gene that are amenable to exon 53 skipping
(DMD-53). It is the second drug to be approved for this
indication; the antisense oligonucleotide golodirsen
(Vyondys 53) was approved in 2019.
Two New Doses of Dulaglutide (Trulicity) for Diabetes
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020 (Issue 1609)
Two New Doses of Dulaglutide
(Trulicity) for Diabetes
Table 1. Results of AWARD-111
A1C Change ...
The FDA has approved two additional doses (3 mg
and 4.5 mg) of the glucagon-like peptide-1 (GLP-1)
receptor agonist dulaglutide (Trulicity – Lilly) for
treatment of type 2 diabetes in adults. Dulaglutide has
been available in 0.75- and 1.5-mg doses for years.
A New Indication for Esketamine Nasal Spray (Spravato)
The Medical Letter on Drugs and Therapeutics • Sep 21, 2020 (Issue 1607)
for
treatment-resistant depression,1 has now been
approved for treatment of depressive symptoms in
adults ...
Esketamine (Spravato – Janssen), an intranasal
N-methyl-D-aspartate (NMDA) receptor antagonist
that was previously approved by the FDA for treatmentresistant
depression,1 has now been approved for
treatment of depressive symptoms in adults with
major depressive disorder (MDD) and acute suicidal
ideation or behavior. Esketamine is the S-enantiomer
of the anesthetic ketamine (Ketalar, and generics).
It is the first drug to be approved for this indication.
Most clinical trials of antidepressants have excluded
patients with acute suicidal ideation.
In Brief: Canagliflozin and Lower Limb Amputations
The Medical Letter on Drugs and Therapeutics • Sep 21, 2020 (Issue 1607)
of the drug.1 Package
inserts for canagliflozin products still contain a standard
warning about a risk ...
The FDA has removed a boxed warning from the labeling
of products containing the sodium-glucose co-transporter
2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet,
Invokamet XR) that described an increased risk of lower
limb amputation associated with use of the drug. Package
inserts for canagliflozin products still contain a standard
warning about a risk of lower limb amputation.
Drugs for COPD
The Medical Letter on Drugs and Therapeutics • Sep 07, 2020 (Issue 1606)
. Several guidelines
and review articles on COPD treatment have been
published in recent years.1-5 ...
The main goals of treatment for chronic obstructive
pulmonary disease (COPD) are to relieve symptoms,
reduce the frequency and severity of exacerbations,
and prevent disease progression. Several guidelines
and review articles on COPD treatment have been
published in recent years. Treatment of acute
exacerbations is not discussed here.