The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid...

Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article...

On January 10, 2013, the FDA issued a news release to announce that it was requiring the manufacturers of the zolpidem-containing products Ambien, Ambien CR, Edluar and...

Colonoscopy remains the preferred method of colorectal cancer screening. Many patients consider cleansing the bowel in preparation for colonoscopy the most unpleasant part of the procedure, but...

The oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for treatment of acne.1 The FDA has recently approved a new oral isotretinoin product...

On page 95 in the "Drug Interactions" paragraph (Med Lett Drugs Ther 2012; 54:95), the word "oral" should have been added before "midazolam" in the 3rd sentence. Stribild is contraindicated...

The FDA has approved apixaban (Eliquis – Bristol-Myers Squibb/Pfizer), an oral direct factor Xa inhibitor, for prevention of stroke and systemic embolism in patients with nonvalvular...

The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the...

Two new trivalent influenza vaccines, Flucelvax (Novartis) and Flublok (Protein Sciences), will soon be available for prevention of seasonal influenza in adults ≥18 years old...

A new epinephrine auto-injector is available in the US (Auvi-Q – Sanofi; Allerject in Canada) for emergency treatment of anaphylaxis. The new device is about the length and width...

Mirabegron (mir a beg’ ron; Myrbetriq [meer BEH trick] – Astellas), a beta-3 adrenergic agonist, has been approved by the FDA for the treatment of overactive bladder. It is the first...

Fungal infections of the fingernails or toenails can persist for months or years despite topical and systemic antimicrobial therapy. The FDA has cleared several short-pulse laser systems for...

Use of proton pump inhibitors (PPIs) to treat gastroesophageal reflux disease (GERD) has been associated with an increase in the risk of fractures. The FDA now requires that the labels of all...

A reader who took the online continuing medical education (CME) exam for issue 1406 (Med Lett Drugs Ther 2012; 54:101) pointed out that the first question assumed that a rash following oral...

Fibrates, niacin and fish oil are promoted for treatment of hypertriglyceridemia. HMG-CoA reductase inhibitors (statins) can lower elevated serum concentrations of triglycerides, but less so than...

Misoprostol (Cytotec, and generics), a prostaglandin E₁ analog FDA-approved for prevention of NSAID-induced gastric ulcers and, when taken with mifepristone (Mifeprex),...

The FDA has approved enzalutamide (en za loo’ ta mide; Xtandi – Astellas/Medivation) for oral treatment of metastatic castration-resistant prostate cancer in patients previously...

The FDA recently approved Skyla (Bayer), the first new intrauterine device (IUD) in the US in 12 years. It releases levonorgestrel, a synthetic progestin, over a period of 3 years. A table...

The FDA has approved a new extended-release formulation of the corticosteroid budesonide (Uceris – Santarus) for induction of remission in patients with mild to moderate ulcerative...

A topical formulation of the antimetabolite mitomycin (Mitosol – Mobius Therapeutics) has been approved by the FDA for adjunctive use in glaucoma surgery to reduce scarring. Compounding...

The FDA has approved mipomersen (Kynamro – Genzyme) and lomitapide (Juxtapid – Aegerion), each in addition to a low-fat diet and other lipid-lowering medications, to reduce...

The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with...

The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac...

Two FDA advisory committees recently concluded that use of a nasal spray formulation of the peptide hormone salmon calcitonin for treatment of postmenopausal osteoporosis is associated with an...

The FDA has approved teduglutide (te due’ gloo tide; Gattex – NPS), a recombinant DNA analog of glucagon-like peptide-2 (GLP-2), for treatment of short bowel syndrome (SBS) in adults...

The FDA has recently approved intradetrusor injection of onabotulinumtoxinA (Botox – Allergan) for treatment of overactive bladder in patients who cannot tolerate or have an inadequate...

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe...

An extended-release injectable formulation of the second-generation antipsychotic aripiprazole (Abilify) has been approved by the FDA (Abilify Maintena – Otsuka/Lundbeck) for...

Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated with multiple other...

Ziv-aflibercept (Zaltrap – Sanofi/Regeneron), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA for use in combination with 5-fluorouracil, leucovorin...

Canagliflozin (kan" a gli floe' zin; Invokana – Janssen), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes.

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting...

The FDA has approved the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (Nesina – Takeda) for treatment of type 2 diabetes. In addition to the single-ingredient product, the FDA...

Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used...

Superseded by The Medical Letter "Inhibitors and Inducers of CYP Enzymes and P-Glycoprotein (online only)" - Issue 1517, March 27, 2017The tables below list the drugs that induce or inhibit...

The FDA is advising health care professionals not to prescribe valproate sodium (Depacon), valproic acid (Depakene, Stavzor, and generics) or divalproex sodium (Depakote,...

The FDA has approved dimethyl fumarate (Tecfidera – Biogen Idec), formerly called BG-12, for treatment of relapsing forms of multiple sclerosis (MS). It is the third oral drug to be...

The FDA has approved use of lubiprostone (Amitiza) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. The drug was previously approved for chronic...

The FDA has approved a fixed-dose combination of the cholesterol absorption inhibitor ezetimibe and the HMG-CoA reductase inhibitor (statin) atorvastatin as Liptruzet (Merck) for treatment...

The results of the Age-Related Eye Disease Study 2 (AREDS2) have now been published. The primary purpose of the study was to evaluate the efficacy and safety of the carotenoids lutein and...

Inhaled antibiotics, which can achieve high concentrations in the lung with minimal systemic side effects, are probably the most effective therapy available for chronic Pseudomonas...

The progestin levonorgestrel is available over the counter for emergency contraception as two 0.75-mg tablets taken 12 hours apart (generic formulations of Plan B) and as a single 1.5-mg...

The FDA has approved use of Kcentra (CSL Behring), a human-derived 4-factor prothrombin complex concentrate (PCC), for urgent reversal of warfarin anticoagulation in adults with acute...

The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin...

The FDA has approved ospemifene (os pem’ i feen; Osphena – Shionogi), an estrogen agonist/antagonist, for oral treatment of moderate to severe dyspareunia in postmenopausal women....

The FDA has approved Simbrinza (Alcon), an ophthalmic combination of the carbonic anhydrase inhibitor brinzolamide and the selective alpha₂-adrenergic receptor agonist...

In 2011, the FDA asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) citalopram (Celexa, and generics) to lower the maximum daily dosage of the drug because of a...

The FDA has approved crofelemer (kroe fel’ e mer; Fulyzaq – Salix), a chloride channel inhibitor derived from the red sap of the South American plant Croton lechleri, for...

The FDA has approved Diclegis (Duchesnay), a fixed-dose, delayed-release combination of the H₁-antihistamine doxylamine and the vitamin B₆ analog pyridoxine, for...

The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and...

Ocriplasmin (Jetrea – ThromboGenics) was recently approved by the FDA as an intravitreal injection for treatment of symptomatic vitreomacular adhesion. It is the first drug to be...

The FDA has approved the interleukin-1 (IL-1) beta inhibitor canakinumab (Ilaris – Novartis) for treatment of systemic juvenile idiopathic arthritis (sJIA; formerly called juvenile...

Bedaquiline (bed ak' wi leen; Sirturo – Janssen), a diarylquinoline antimycobacterial, has been given accelerated approval by the FDA as an orphan drug for use in addition to other drugs...

The FDA has approved a new oral solution of the calcium channel blocker nimodipine (Nymalize – Arbor) to reduce the severity of neurological deficits associated with vasospasm after...

The FDA has approved an inhaled fixed-dose combination (Breo Ellipta – GSK/Theravance) of the corticosteroid fluticasone furoate and the long-acting beta₂-adrenergic agonist...

Ponatinib (Iclusig – Ariad), a tyrosine kinase inhibitor, has been approved by the FDA for treatment of chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) or...

Superseded by The Medical Letter "Influenza Vaccine for 2020-2021" - Issue 1607, September 21, 2020Annual vaccination against influenza A and B viruses has been shown to decrease influenza...

Ado-trastuzumab emtansine (Kadcyla – Genentech), a human epidermal growth factor receptor 2 (HER2)-targeted antibody and microtubule inhibitor conjugate, has been approved by the FDA for...

The transdermal patch formulation of the anticholinergic drug oxybutynin (Oxytrol – Watson) is now available over the counter (OTC) as Oxytrol for Women (MSD) for use in women...

Full-page newspaper advertisements and a series of television commercials have urged patients with atrial fibrillation to "rethink warfarin" in favor of Eliquis (apixaban – Bristol-Myers...

The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in...

Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone...

Deep brain stimulation is FDA-approved and has been used for years to treat patients with advanced Parkinson's disease (PD) who have severe levodopa-induced motor complications. New evidence from...

The FDA has approved the selective alpha₂-adrenergic receptor agonist brimonidine as a 0.33% gel (Mirvaso – Galderma) for topical treatment of adults with persistent facial...

A new sublingual tablet formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Zubsolv – Orexo) has been approved by the FDA for maintenance...

Some readers have objected to our recommendation (Med Lett Drugs Ther 2013; 55:55) that postmenopausal women with an intact uterus who take the oral estrogen agonist/antagonist ospemifene...

The FDA has approved a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle – Noven Therapeutics) for treatment of moderate-to-severe...

Belotero Balance (Merz), an injectable hyaluronic acid dermal filler, has been approved by the FDA for temporary correction of moderate-to-severe facial wrinkles and folds. Several other...

The FDA has approved a once-daily extended-release (ER) formulation of the antiepileptic topiramate (Trokendi XR – Supernus) for initial monotherapy in patients ≥10 years old with...

The CDC recently announced that it will now supply the investigational drug miltefosine (Impavido – Paladin, Canada) for treatment of infections caused by free-living amebae.1 The drug...

The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy...

Electronic cigarettes, also called e-cigarettes, are advertised as a safer, more convenient, and socially acceptable alternative to smoking tobacco cigarettes. Widely available in retail stores...

The FDA has approved the over-the-counter (OTC) sale of Nasacort Allergy 24HR (Sanofi), a triamcinolone acetonide nasal spray previously available only by prescription as Nasacort...

The FDA has approved the use of a permanent prostatic urethral lift implant (UroLift – NeoTract) to relieve low or blocked urine flow in men ≥50 years old with benign prostatic...

Rates of meningococcal disease are highest in infancy, but until recently no meningococcal vaccine was approved for use in this age group. MenHibrix (GSK), a new conjugate vaccine that...

The FDA recently issued a Drug Safety Communication saying that it had asked the manufacturer of ponatinib (Iclusig – Ariad) to suspend marketing and sales of the drug because of the risk...

The FDA has approved vortioxetine (vor" tye ox' e teen; Trintellix – Takeda/Lundbeck), a new serotonergic drug, for treatment of major depressive disorder. Like...

An oral solution (Vituz – Hawthorne) containing two old drugs, the centrally-acting opioid hydrocodone bitartrate and the first-generation H₁-antihistamine...

The FDA recently announced changes in the labeling of ezogabine (Potiga – GSK/Valeant) to warn about the risks of retinal abnormalities, possible vision loss, and bluish skin...

An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational...

The FDA has approved the MiniMed 530G (Medtronic), an insulin pump used in combination with a continuous glucose monitoring sensor (Enlite) that can stop delivery of insulin when...

The FDA has approved the neoadjuvant (preoperative) use of pertuzumab (Perjeta – Genentech) in combination with trastuzumab (Herceptin) and docetaxel (Taxotere, and...

The FDA has approved ferric carboxymaltose (Injectafer – American Regent), a 2-dose intravenous iron replacement product, for treatment of iron deficiency anemia (IDA) in adults who...

The FDA has approved levomilnacipran (lee" voe mil na' si pran; Fetzima – Forest), a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder....

Three tumor necrosis factor (TNF) inhibitors – infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia) – are approved by the FDA for treatment of...

The FDA has approved the use of a transcatheter mitral valve device (MitraClip – Abbott) for percutaneous treatment of significant symptomatic degenerative mitral regurgitation (grade...

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