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Exablate Neuro for Essential Tremor
The Medical Letter on Drugs and Therapeutics • Mar 27, 2017 (Issue 1517)
head and voice tremor.1,2
Surgical ablation of the ventral intermediate nucleus
of the thalamus ...
The FDA has approved use of Exablate Neuro (Insightec)
for unilateral thalamotomy to treat medication-refractory
essential tremor in patients ≥22 years old.
Exablate Neuro uses magnetic resonance-guided
focused ultrasound (MRgFUS) to create lesions in the
ventral intermediate nucleus of the thalamus. MRgFUS
is also approved in the US for treatment of uterine
fibroids and for pain palliation of bone metastases.
Nusinersen (Spinraza) for Spinal Muscular Atrophy
The Medical Letter on Drugs and Therapeutics • Mar 27, 2017 (Issue 1517)
that occurs in
about one in every 10,000 births.1 It is the first drug to
be approved ...
The FDA has approved nusinersen (Spinraza – Biogen)
for treatment of spinal muscular atrophy (SMA), a
hereditary neurodegenerative disease that occurs in
about one in every 10,000 births. It is the first drug to
be approved in the US for this indication.
Obeticholic Acid (Ocaliva) for Primary Biliary Cholangitis
The Medical Letter on Drugs and Therapeutics • Mar 27, 2017 (Issue 1517)
of the
intralobular bile ducts that can lead to fibrosis,
cirrhosis, and liver failure.1 It most commonly affects ...
Obeticholic acid (Ocaliva – Intercept), a farnesoid X
receptor agonist, has been approved by the FDA for
treatment of primary biliary cholangitis; it is indicated
for use in combination with ursodeoxycholic acid
(ursodiol, UDCA; Urso, and others) in adults with an
inadequate response to UDCA and as monotherapy in
adults unable to tolerate UDCA. Obeticholic acid is the
second drug to be approved for this indication; UDCA
was the first.
Triferic for Iron Replacement
The Medical Letter on Drugs and Therapeutics • Mar 27, 2017 (Issue 1517)
of FPC solution was
based on the results of two identically designed,
single-blind trials (CRUISE 1 ...
The FDA has approved ferric pyrophosphate
citrate solution (Triferic – Rockwell Medical) to
maintain hemoglobin concentrations in adults with
hemodialysis-dependent chronic kidney disease.
Triferic is the first iron replacement product that is
added into the hemodialysis solution at each dialysis
procedure.
Kyleena - Another Hormonal IUD
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
and nulliparous women.1 All
levonorgestrel-releasing IUDs, which are approved for
3 or 5 years of use, can ...
The FDA has approved Kyleena (Bayer), an intrauterine
device (IUD) that releases the synthetic progestin
levonorgestrel, for prevention of pregnancy. It is the
fourth levonorgestrel-releasing IUD to be approved in
the US. Like Mirena, which has been available since
2000, Kyleena is approved for up to 5 years of use.
Crisaborole (Eucrisa) for Atopic Dermatitis
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
,
telangiectasias, and permanent striae.1,2
The topical calcineurin inhibitors tacrolimus (Protopic,
and generics ...
The FDA has approved crisaborole 2% ointment
(Eucrisa – Pfizer) for topical treatment of mild to
moderate atopic dermatitis in patients ≥2 years old. It
is the first phosphodiesterase type-4 (PDE4) inhibitor
to be approved in the US for this indication.
Anticoagulation of Elderly Patients at High Risk for Falls with Atrial Fibrillation
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
With the widespread adoption of the CHA2DS2-VASc
scoring system,1 oral anticoagulation therapy is
now recommended ...
With the widespread adoption of the CHA2DS2-VASc
scoring system, oral anticoagulation therapy is
now recommended for all patients ≥75 years old
with nonvalvular atrial fibrillation. Atrial fibrillation
has, however, been associated with an increased
risk of falls, and older patients starting warfarin for
atrial fibrillation have a high rate of hospitalization
for intracranial bleeding. Many practitioners are
reluctant, therefore, to prescribe an oral anticoagulant
for elderly patients who are at high risk for falls.
Auvi-Q Epinephrine Auto-Injector Returns
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
to potential inaccurate dosage delivery,1 has
become available once more. According to Kaléo,
improvements ...
Auvi-Q (Kaléo; previously manufactured and
marketed by Sanofi), the epinephrine auto-injector
approved by the FDA in 2012 for emergency treatment
of anaphylaxis and voluntarily withdrawn in 2015
due to potential inaccurate dosage delivery, has
become available once more. According to Kaléo,
improvements in the manufacturing process have
addressed the concerns that led to its recall.
Extended-Release Calcifediol (Rayaldee) for Secondary Hyperparathyroidism
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
vitamin D to calcitriol
(1,25-dihydroxyvitamin D3). Reduced synthesis of
calcitriol leads to low levels ...
The FDA has approved extended-release (ER)
calcifediol (25-hydroxyvitamin D3; Rayaldee –
Opko), a prohormone of calcitriol, the active form of
vitamin D3. It is indicated for treatment of secondary
hyperparathyroidism (SHPT) in adults with stage 3 or
4 chronic kidney disease (CKD) who have serum total
25-hydroxyvitamin D levels <30 ng/mL.
Drug Interaction: Clopidogrel and PPIs
The Medical Letter on Drugs and Therapeutics • Feb 27, 2017 (Issue 1515)
may interfere with the activation of clopidogrel and
diminish its antiplatelet effect.1 FDA-approved labeling ...
The antiplatelet drug clopidogrel (Plavix, and others)
reduces major cardiovascular events, but can cause
bleeding. Proton pump inhibitors (PPIs) are often
used with clopidogrel to prevent gastrointestinal
bleeding, however, some evidence suggests that PPIs
may interfere with the activation of clopidogrel and
diminish its antiplatelet effect. FDA-approved labeling
recommends avoiding concurrent use of the PPIs
omeprazole and esomeprazole with clopidogrel.