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Addendum: Doxycycline for Young Children?
The Medical Letter on Drugs and Therapeutics • Jun 20, 2016 (Issue 1497)
for calcium than other tetracyclines, have
not been shown to cause tooth staining.1 That statement ...
A reader commenting on our Treatment of Lyme Disease article (Med Lett Drugs Ther 2016; 58:57) objected to a footnote in the table advising against use of doxycycline in children <8 years old. This warning has been included in the labeling of all tetracyclines since 1970 when it was recognized, after decades of use, that these drugs caused permanent staining and enamel hypoplasia of developing teeth. The CDC recently stated that short courses of doxycycline, which was first marketed in the US in 1967 and has less affnity for calcium than other tetracyclines, have not been shown to cause...
A New Abuse-Deterrent Opioid - Xtampza ER
The Medical Letter on Drugs and Therapeutics • Jun 20, 2016 (Issue 1497)
as single-drug products and two in
combinations with opioid antagonists.1 Two of
these products ...
The FDA has approved Xtampza ER (Collegium),
a new extended-release, abuse-deterrent capsule
formulation of oxycodone, for management of pain
severe enough to require daily, around-the-clock,
long-term opioid treatment and for which alternative
treatment options are inadequate.
Two New Amphetamines for ADHD
The Medical Letter on Drugs and Therapeutics • Jun 20, 2016 (Issue 1497)
, vary in duration
of action, but appear to be similar in efficacy.1,2 All
stimulants used ...
Two new extended-release amphetamine products
have been approved by the FDA for once-daily
treatment of attention-deficit/hyperactivity disorder
(ADHD) in patients ≥6 years old: Adzenys XR-ODT
(Neos Therapeutics), an orally distintegrating tablet,
and Dyanavel XR (Tris Pharma), an oral suspension.
Reslizumab (Cinqair) for Severe Eosinophilic Asthma
The Medical Letter on Drugs and Therapeutics • Jun 20, 2016 (Issue 1497)
to be approved in the
US; mepolizumab (Nucala) was approved for the same
indication in 2015.1
EOSINOPHILIC ...
The FDA has approved reslizumab (Cinqair – Teva), a
humanized interleukin-5 (IL-5) antagonist monoclonal
antibody, for add-on maintenance treatment of severe
asthma in adults who have an eosinophilic phenotype.
It is the second IL-5 antagonist to be approved in the
US; mepolizumab (Nucala) was approved for the same
indication in 2015.
Pimavanserin (Nuplazid) for Parkinson's Disease Psychosis
The Medical Letter on Drugs and Therapeutics • Jun 06, 2016 (Issue 1496)
% of patients with
Parkinson’s disease.1 Low doses of clozapine
(Clozaril, and others) have been effective ...
The FDA has approved the atypical antipsychotic
pimavanserin (Nuplazid – Acadia) for treatment
of hallucinations and delusions associated with
Parkinson's disease. It is the first drug to be approved
in the US for this indication.
Alternatives to Fluoroquinolones
The Medical Letter on Drugs and Therapeutics • Jun 06, 2016 (Issue 1496)
with no other treatment options.1
Table 1. Systemic Fluoroquinolones Available in the US
Ciprofloxacin (Cipro ...
The FDA has announced that it is requiring changes in
the labeling of systemic fluoroquinolones to warn that
the risk of serious adverse effects, including tendinitis,
peripheral neuropathy and CNS effects, generally outweighs
their benefit for the treatment of acute sinusitis,
acute exacerbations of chronic bronchitis, and uncomplicated
urinary tract infections. For these infections, the
new labels will recommend reserving fluoroquinolones
for patients with no other treatment options.
In Brief: New Indications for Secukinumab (Cosentyx)
The Medical Letter on Drugs and Therapeutics • Jun 06, 2016 (Issue 1496)
and ankylosing spondylitis
in adults.1 Secukinumab is one of the most effective drugs
available for treatment ...
The FDA has approved the subcutaneous IL-17A antagonist secukinumab (Cosentyx - Novartis), which was first approved in 2015 for treatment of plaque psoriasis, for treatment of psoriatic arthritis and ankylosing spondylitis in adults.1 Secukinumab is one of the most effective drugs available for treatment of plaque psoriasis.2FDA approval of secukinumab for treatment of psoriatic arthritis was based on two randomized, double-blind trials with a primary endpoint of at least a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 24 weeks. In both trials, ACR20...
In Brief: Liposomal Irinotecan (Onivyde) for Pancreatic Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Jun 06, 2016 (Issue 1496)
to irinotecan and improves the cellular uptake
and cytotoxic effect of the drug.1
FDA approval of liposomal ...
A liposomal formulation of irinotecan (Onivyde – Merrimack) has been approved by the FDA for use in combination with fluorouracil and leucovorin for treatment of metastatic pancreatic cancer that has progressed after gemcitabine-based therapy. A non-liposomal formulation of irinotecan (Camptosar, and generics) has been available in the US for many years. The liposomal carrier prolongs exposure to irinotecan and improves the cellular uptake and cytotoxic effect of the drug.1FDA approval of liposomal irinotecan was based on the results of an open-label trial (NAPOLI-1) in 417 patients with...
In Brief: Trifluridine/Tipiracil (Lonsurf) for Metastatic Colorectal Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Jun 06, 2016 (Issue 1496)
with trifluridine/tipiracil compared to
placebo (7.1 months vs 5.3 months). Median progressionfree
survival ...
The FDA has approved Lonsurf (Taiho Oncology), a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil, for oral treatment of metastatic colorectal cancer. Trifluridine is incorporated into DNA, interfering with DNA synthesis and inhibiting cell proliferation. Tipiracil inhibits the metabolism of trifluridine. The combination is only approved for use in patients who were previously treated with a fluoropyrimidine (fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF biological such as bevacizumab, and, if the tumor...
Antimicrobial Prophylaxis for Surgery
The Medical Letter on Drugs and Therapeutics • May 23, 2016 (Issue 1495)
the last Medical Letter
article on this subject, consensus guidelines have
been published.1 ...
Antimicrobial prophylaxis can decrease the
incidence of postoperative surgical site infection
after some procedures. Since the last Medical Letter
article on this subject, consensus guidelines have
been published. Recommendations for prophylaxis
in specific surgical procedures are listed in Table 1.