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The Medical Letter on Drugs and Therapeutics • August 17, 2015 (Issue 1475)
The FDA has approved the subcutaneously injected PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor alirocumab (Praluent – Sanofi/Regeneron) as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol (LDL-C)....
The Medical Letter on Drugs and Therapeutics • August 3, 2015 (Issue 1474)
The FDA has approved Entresto (Novartis), an oral fixed-dose combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan, to reduce the risk of cardiovascular death and heart failure hospitalization in patients with heart failure with reduced ejection fraction. Sacubitril is the first neprilysin inhibitor to become available in the US.
The Medical Letter on Drugs and Therapeutics • June 22, 2015 (Issue 1471)
The injectable glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide, previously approved by the FDA for treatment of type 2 diabetes as Victoza, has now also been approved at a higher dose as Saxenda (Novo Nordisk) for chronic weight management in adults with a BMI ≥30, or a BMI ≥27 with a weight-related comorbidity such as hypertension, dyslipidemia, or diabetes....
The Medical Letter on Drugs and Therapeutics • June 22, 2015 (Issue 1471)
The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga, Xigduo XR), and empagliflozin (Jardiance, Glyxambi), are approved for treatment of type 2 diabetes in the...
The Medical Letter on Drugs and Therapeutics • April 27, 2015 (Issue 1467)
The FDA has approved a 0.016% gel formulation of the nitrogen mustard mechlorethamine (Valchlor – Actelion) for second-line topical treatment of patients with stage IA or IB mycosis fungoides, the most common type of cutaneous T-cell lymphoma. Topical nitrogen mustard has been used off-label for decades for this indication, usually as a pharmacy-compounded ointment, but no clinical...
The Medical Letter on Drugs and Therapeutics • April 13, 2015 (Issue 1466)
The FDA recently announced changes in the labeling of the hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) to warn about a risk of serious and potentially fatal bradycardia when either drug is taken with the antiarrhythmic drug amiodarone (Cordarone, and others).1 Symptomatic bradycardia was reported...
The Medical Letter on Drugs and Therapeutics • March 30, 2015 (Issue 1465)
The FDA has approved edoxaban (Savaysa – Daiichi Sankyo), a once-daily, oral, direct factor Xa inhibitor, for treatment of venous thromoboembolism (VTE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is the fourth new oral anticoagulant to be approved for VTE and nonvalvular atrial fibrillation.
The Medical Letter on Drugs and Therapeutics • March 16, 2015 (Issue 1464)
Vascular endothelial growth factor (VEGF) is a principal mediator of neovascularization in wet age-related macular degeneration (AMD) and diabetic macular edema. It induces angiogenesis and increases vascular permeability and inflammation. VEGF inhibitors reduce leakage from blood vessels, prevent proliferation of new abnormal vessels, decrease swelling of the retina, and improve visual acuity in...
The Medical Letter on Drugs and Therapeutics • March 16, 2015 (Issue 1464)
Lisdexamfetamine dimesylate (Vyvanse), a prodrug of dextroamphetamine previously approved for treatment of attention-deficit/hyperactivity disorder, has now been approved for treatment of moderate-to-severe binge eating disorder (recurrent episodes of compulsive overeating without purging) in adults.

FDA approval of lisdexamfetamine for this indication was based on two...
The Medical Letter on Drugs and Therapeutics • March 2, 2015 (Issue 1463)
The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza – Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was...
The Medical Letter on Drugs and Therapeutics • February 2, 2015 (Issue 1461)
The FDA has approved Viekira Pak (Abbvie), a fixed-dose combination of two new direct-acting antiviral agents (ombitasvir, paritaprevir) with the pharmacologic enhancer ritonavir in one tablet, co-packaged with a third new direct-acting antiviral agent (dasabuvir) in a second tablet, for oral treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for...
The Medical Letter on Drugs and Therapeutics • February 2, 2015 (Issue 1461)
The FDA has approved an IV formulation of the antifungal drug posaconazole (Noxafil - Merck) for prophylaxis of Aspergillus and Candida infections in adults at high risk for these infections, such as those with prolonged neutropenia. Posaconazole is also available as delayed-release tablets and an oral suspension.

With activity against Aspergillus...
The Medical Letter on Drugs and Therapeutics • January 19, 2015 (Issue 1460)
Heart failure is usually associated with left ventricular dysfunction. According to recent guidelines, patients with a left ventricular ejection fraction (LVEF) ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF) or systolic heart failure. Patients with a LVEF ≥50% and symptoms of heart failure are considered to have heart failure with preserved ejection...
The Medical Letter on Drugs and Therapeutics • January 19, 2015 (Issue 1460)
Some readers of our article on Antiviral Drugs for Seasonal Influenza1 have expressed concerns regarding our recommendation for use of the oral neuraminidase inhibitor oseltamivir (Tamiflu) to treat high-risk patients with confirmed or suspected influenza illness, citing the British Medical Journal and The Cochrane Collaboration, which have...
The Medical Letter on Drugs and Therapeutics • January 5, 2015 (Issue 1459)
The CDC has announced that the most common influenza viruses circulating now are influenza A H3N2, which tend to cause more severe disease, and that about half of these viruses are antigenically different from the H3N2 strain in this year’s flu vaccine.1 Vaccination may still have a protective effect, even against drifted variants, and patients who have not received this year...
The Medical Letter on Drugs and Therapeutics • December 8, 2014 (Issue 1457)
Antiviral drugs can be used for treatment of influenza and as an adjunct to influenza vaccination for prophylaxis. Frequently updated information on influenza activity and antiviral resistance is available from the CDC at www.cdc.gov/flu.
The Medical Letter on Drugs and Therapeutics • December 8, 2014 (Issue 1457)
The FDA has approved fixed-dose combinations of metformin with either canagliflozin (Invokamet) or dapagliflozin (Xigduo XR) for treatment of patients with type 2 diabetes not adequately controlled with any one of these drugs, or in those already being treated with both metformin and either canagliflozin or dapagliflozin.
The Medical Letter on Drugs and Therapeutics • December 8, 2014 (Issue 1457)
The FDA has approved a new extended-release capsule formulation of topiramate (Qudexy XR – Upsher Smith), which can be opened and sprinkled on food for patients who have difficulty swallowing tablets or capsules, for treatment of epilepsy. Qudexy XR was marketed as a branded drug in March 2014 and as a generic drug four months later. An earlier extended-release formulation (...
The Medical Letter on Drugs and Therapeutics • December 8, 2014 (Issue 1457)
Combining a statin with another drug that lowers low-density lipoprotein cholesterol (LDL-C), such as colesevelam (Welchol), niacin (Niaspan, and others), or ezetimibe (Zetia), can reduce LDL-C levels more than a statin alone, but studies convincingly demonstrating that such combinations improve clinical outcomes have been lacking. The results of a long-term randomized...
The Medical Letter on Drugs and Therapeutics • October 13, 2014 (Issue 1453)
The FDA has approved Cologuard (Exact Sciences), a stool DNA test, to screen average-risk adults ≥50 years old for colorectal cancer.