In Brief: Risk of Pulmonary Thromboembolism and Death with Tofacitinib (Xeljanz)
Date: August 26, 2019
Issue #:
1579Summary:
The FDA has required updates to the labeling of the Janus kinase (JAK) inhibitor tofacitinib(Xeljanz, Xeljanz XR) based on interim results of a postmarketing safety trial that showed an increased risk of pulmonary thromboembolism and death with a dosage of 10 mg twice daily.1 Tofacitinib is approved for treatment of rheumatoid arthritis (RA),2 psoriatic arthritis, and ulcerative colitis.In the postmarketing trial, RA patients ≥50 years old taking methotrexate who had at least one cardiovascular risk factor were randomized to receive a...
Source: The Medical Letter - August 19, 2019 Category: Drugs & Pharmacology Authors: admin Source Type: research
Dolutegravir/Lamivudine (Dovato) - A Two-Drug Complete Regimen for HIV-1 Infection
Date: August 26, 2019
Issue #:
1579Summary:
The FDA has approvedDovato (ViiV), a fixed-dose
combination of the integrase strand transfer inhibitor
(INSTI) dolutegravir(Tivicay) and the nucleoside
reverse transcriptase inhibitor (NRTI) lamivudine
(Epivir, and generics), as a once-daily complete
regimen for treatment of adults with HIV-1 infection
who are antiretroviral-treatment naive and have no
known substitutions associated with resistance
to either drug. Dolutegravir/lamivudine is the first
complete regimen to be approved by the FDA for
initial treatment of HIV-1 infection tha...
Source: The Medical Letter - August 19, 2019 Category: Drugs & Pharmacology Authors: admin Source Type: research
Note: Zolgensma Data Manipulation
Date: August 26, 2019
Issue #:
1579Summary:
On August 6, 2019, the FDA issued a statement on data manipulation/inaccuracy issues withZolgensma, a virus vector-based gene therapy approved for one-time IV treatment of children<2 years old with spinal muscular atrophy.1 We reviewedZolgensma in our July 29 issue.2 According to the FDA statement, the manipulated data pertained to the production process for the product and did not affect the efficacy or safety results from the human clinical trials. It does not require any change in our review.FDA Statement. Statement on data accura...
Source: The Medical Letter - August 19, 2019 Category: Drugs & Pharmacology Authors: admin Source Type: research
Drugs for Atrial Fibrillation
Date: September 9, 2019
Issue #:
1580Summary:
Treatment of atrial fibrillation includes anticoagulation,
rate control, and rhythm control. US guidelines were
recently updated. (Source: The Medical Letter)
Source: The Medical Letter - August 6, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Amiodarone andexanet alfa Anticoagulants apixaban Atenolol Atrial fibrillation Beta blockers Betapace Bisoprolol Brevibloc Calan Calcium-channel blockers Cardizem Cartia Carvedilol Coreg Corgard Coumadin Dabigatran Di Source Type: research
Qmiiz ODT - An Orally Disintegrating Meloxicam Tablet
Date: September 23, 2019
Issue #:
1581Summary:
The FDA has approvedQmiiz ODT (TerSera), an orally
disintegrating tablet formulation of the prescription
NSAID meloxicam.Qmiiz ODT, like conventional oral
meloxicam tablets (Mobic, and generics), is indicated
for relief of the symptoms of osteoarthritis (OA) and
rheumatoid arthritis (RA) in adults and of juvenile RA
in children who weigh≥60 kg.Vivlodex, a low-dose
capsule formulation of meloxicam, is FDA-approved
only for management of OA pain. (Source: The Medical Letter)
Source: The Medical Letter - August 6, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Meloxicam Mobic NSAIDs Osteoarthritis Qmiiz ODT Rheumatoid arthritis Vivlodex Source Type: research
Insect Repellents
Date: August 26, 2019
Issue #:
1579Summary:
Use of insect repellents is strongly recommended by the
Centers for Disease Control and Prevention (CDC) and
the Environmental Protection Agency (EPA) to prevent
infections transmitted by mosquitoes and ticks. Insect
repellents applied to exposed skin should be used in
conjunction with other preventive measures such as
wearing pants and long-sleeved shirts, and avoiding
outdoor activities during peak mosquito-biting times.
Mosquitoes can transmit Zika, chikungunya, dengue,
West Nile, eastern equine encephalitis, and yellow fever
viruse...
Source: The Medical Letter - July 24, 2019 Category: Drugs & Pharmacology Authors: admin Source Type: research
Solriamfetol (Sunosi) for Excessive Daytime Sleepiness
Date: August 26, 2019
Issue #:
1579Summary:
The FDA has approved solriamfetol (Sunosi– Jazz),
a dopamine and norepinephrine reuptake inhibitor
(DNRI), to improve wakefulness in adults with excessive
daytime sleepiness (EDS) associated with narcolepsy
or obstructive sleep apnea (OSA). Pitolisant(Wakix),
an H3-receptor antagonist/inverse agonist recently
approved by the FDA for treatment of excessive
daytime sleepiness in patients with narcolepsy, will be
reviewed in a future issue. (Source: The Medical Letter)
Source: The Medical Letter - July 24, 2019 Category: Drugs & Pharmacology Authors: admin Source Type: research
Jornay PM - Evening-Dosed Methylphenidate for ADHD
Date: August 12, 2019
Issue #:
1578Summary:
The FDA has approvedJornay PM (Ironshore), a
capsule formulation of methylphenidate with a
delayed-release outer layer and an extended-release
inner layer, for once-nightly treatment of attention-deficit hyperactivity disorder (ADHD) in patients>6
years old.Jornay PM is the first methylphenidate
product to become available in the US that is taken
in the evening; other long-acting methylphenidate
formulations are taken in the morning. It is being
marketed specifically for patients who have disruptive
ADHD symptoms in the morning. (Sou...
Source: The Medical Letter - July 24, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Adhansia ADHD Aptensio Biphentin Concerta Contempla daytrana Dexmethylphenidate Focalin Foquest Jornay PM QuiliChew Quilivant Ritalin Source Type: research
Correction: Plenvu
Date: July 29, 2019
Issue #:
1577Summary:
In our article in issue 1564 onPlenvu for colonoscopy preparation(Med Lett Drugs Ther 2019; 61:11), the comparator drug in the DAYB trial was notPrepopik, but ratherCitrafleet, a similar sodium picosulfate-based preparation that is not available in the US. Also, we said thatPlenvu can be taken as a single- or split-dose regimen; we should have said that it can be taken as two doses in a single day or split over two days. (Source: The Medical Letter)
Source: The Medical Letter - July 22, 2019 Category: Drugs & Pharmacology Authors: admin Tags: bowel preparation Cancer screening Citrafleet Colonoscopy colorectal cancer Plenvu Prepopik sodium picosulfate Source Type: research
Addendum: Estradiol/Progesterone (Bijuva) for Menopausal Vasomotor Symptoms
Date: July 29, 2019
Issue #:
1577Summary:
In our article onBijuva, the oral fixed-dose combination of estradiol and progesterone(Med Lett Drugs Ther 2019; 61:99), Table 1 should have included single-ingredient oral formulations of estradiol and progesterone (see below). They will be added to the table as it appears online, along with medroxyprogesterone (Provera, and generics), another single-ingredient progestin available for use in women with an intact uterus who take systemic estrogen for menopausal symptoms. Taking generic estradiol and progesterone separately may be less con...
Source: The Medical Letter - July 22, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Bijuva Bioidentical Hormones Estrogens Hot flashes Medroxyprogesterone Menopause Progestins Prometrium Provera Source Type: research
Expanded Table: Some Drugs for Smoking Cessation (online only)
Date: July 15, 2019
Issue #:
1576Summary:
View the Expanded Table: Some Drugs for Smoking Cessation (Source: The Medical Letter)
Source: The Medical Letter - July 2, 2019 Category: Drugs & Pharmacology Authors: admin Source Type: research
Benzhydrocodone/Acetaminophen (Apadaz) for Pain
Date: July 15, 2019
Issue #:
1576Summary:
The FDA has approvedApadaz (KemPharm), a short-acting,
fixed-dose combination of benzhydrocodone
and acetaminophen, for short-term management
(≤14 days) of acute pain severe enough to require an
opioid and for which alternative treatment options
are inadequate. Benzhydrocodone is a prodrug of
hydrocodone. Fixed-dose combinations of short-acting
hydrocodone and acetaminophen or ibuprofen
have been available for years and are the most abused
opioid products in the US.Apadaz was developed
under the presumption that inclusion of the inacti...
Source: The Medical Letter - July 2, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Acetaminophen Apadaz benzhydrocodone Ibudone Ibuprofen Norco NSAIDs Opioids Pain Tramacet tramadol Ultracet Vicoprofen Xylon Source Type: research
Drugs for Anxiety Disorders
Date: August 12, 2019
Issue #:
1578Summary:
Anxiety disorders (generalized anxiety disorder, panic
disorder, social anxiety disorder, and various phobias)
are the most common form of psychiatric illness. They
can be treated effectively with cognitive behavioral
therapy (CBT) and/or pharmacotherapy. Obsessive-compulsive
disorder and posttraumatic stress
disorder are now considered separate entities in the
Diagnostic and Statistical Manual of Mental Disorders
(DSM-5); they can also be treated with CBT and many
of the same drugs. (Source: The Medical Letter)
Source: The Medical Letter - June 27, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Alprazolam Amitriptyline Antidepressants Antihistamines Antipsychotics Atarax Ativan Beta blockers Buspirone Cannabidiol Celexa Chlordiazepoxide Cipralex Citalopram Clonazepam Clorazepate Cymbalta Diazepam Doxepin Dri Source Type: research
Cladribine (Mavenclad) for Multiple Sclerosis
Date: July 29, 2019
Issue #:
1577Summary:
The FDA has approved cladribine (Mavenclad– EMD
Serono), a purine antimetabolite, for oral treatment
of adults with relapsing forms of multiple sclerosis
(MS), including relapsing-remitting disease and
active secondary progressive MS (SPMS), who
cannot tolerate or have had an inadequate response
to other drugs indicated for treatment of M S. It is
not recommended for use in patients with clinically isolated syndrome (CIS). IV cladribine, which is FDA-approved
for treatment of hairy cell leukemia, has been
used off-label for treatment of...
Source: The Medical Letter - June 27, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Alemtuzumab Aubagio Avonex Cladribine Copaxone dimethyl fumarate Fingolimod Gilenya Glatiramer acetate Interferon beta Lemtrada Mavenclad Mayzent Multiple sclerosis Natalizumab ocrelizumab Ocrevus Plegridy siponimod T Source Type: research
Zolgensma - One-Time Gene Therapy for Spinal Muscular Atrophy
Date: July 29, 2019
Issue #:
1577Summary:
The FDA has approved onasemnogene abeparvovec-xioi (Zolgensma– Avexis), an adeno-associated virus
vector-based gene therapy, for one-time IV treatment
of children<2 years old who have spinal muscular
atrophy (SMA) and bi-allelic mutations in the survival
motor neuron 1 (SMN1) gene. It is the first gene therapy
and the second drug to be approved in the US for SMA;
nusinersen(Spinraza) was approved in 2016. (Source: The Medical Letter)
Source: The Medical Letter - June 27, 2019 Category: Drugs & Pharmacology Authors: admin Tags: nusinersen onasemnogene abeparvovec spinal muscular atrophy Spinraza zolgensma Source Type: research
