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The Medical Letter on Drugs and Therapeutics • May 9, 2016 (Issue 1494)
Most cases of Lyme disease in the US occur between May and September in the Northeastern, Mid-Atlantic, and North Central states.
The Medical Letter on Drugs and Therapeutics • March 14, 2016 (Issue 1490)
Three coordinated double-blind, placebo-controlled clinical trials have evaluated the efficacy of one year of testosterone replacement therapy in improving sexual function, physical function, and vitality in a total of 790 men ≥65 years old with moderately low serum testosterone concentrations and symptoms suggesting hypoandrogenism. Sexual function improved modestly, and there appeared to be...
The Medical Letter on Drugs and Therapeutics • February 29, 2016 (Issue 1489)
Tobacco dependence remains the primary preventable cause of death in the United States. It is a chronic disorder that often requires pharmacologic therapy, but counseling may be equally effective and can add to the effectiveness of any treatment for this indication. Abrupt cessation of smoking appears to be as effective as gradual reduction.
The Medical Letter on Drugs and Therapeutics • February 15, 2016 (Issue 1488)
The FDA has approved Genvoya (Gilead), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for treatment of HIV-1 infection in patients ≥12 years old. This is the first approval for tenofovir...
The Medical Letter on Drugs and Therapeutics • January 4, 2016 (Issue 1485)
Harvoni, a once-daily fixed-dose combination of the direct-acting antiviral agents ledipasvir and sofosbuvir approved by the FDA in 2014 for treatment of hepatitis C virus (HCV) genotype 1 infection,1 has now been approved for use in patients infected with HCV genotype 4, 5, or 6, and in patients co-infected with HCV and HIV-1. A 12-week course of...
The Medical Letter on Drugs and Therapeutics • December 21, 2015 (Issue 1484)
In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and...
The Medical Letter on Drugs and Therapeutics • December 7, 2015 (Issue 1483)
Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not even comment on the safety or effectiveness of their products beyond the date on the label. Since our last publication on this subject, more data have become available.
The Medical Letter on Drugs and Therapeutics • November 23, 2015 (Issue 1482)
The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic hepatitis C virus (HCV) genotype 4 infection in patients without cirrhosis. It is indicated for use in combination with ribavirin. Ombitasvir/paritaprevir/ritonavir copackaged with...
The Medical Letter on Drugs and Therapeutics • November 9, 2015 (Issue 1481)
The FDA recently announced labeling changes for the combination antiviral products Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir)1 and Technivie (ombitasvir/paritaprevir/ritonavir)2 warning of a risk of serious, potentially fatal liver injury.3 ...
The Medical Letter on Drugs and Therapeutics • October 26, 2015 (Issue 1480)
The short-acting beta2-agonist albuterol sulfate is now available as a dry powder for inhalation (ProAir RespiClick – Teva) for prevention and treatment of broncho spasm in patients ≥12 years old. ProAir RespiClick is the only short-acting beta2-agonist dry powder inhaler available in the US.

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The Medical Letter on Drugs and Therapeutics • October 12, 2015 (Issue 1479)
Evolocumab (Repatha – Amgen), a subcutaneously injected PCSK9 inhibitor, has been approved by the FDA 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). It was also approved as an adjunct to diet and other...
The Medical Letter on Drugs and Therapeutics • September 28, 2015 (Issue 1478)
The FDA has approved naloxegol (Movantik – AstraZeneca), a pegylated derivative of the opioid antagonist naloxone, for oral treatment of opioid-induced constipation in adults with chronic noncancer pain. It is the only oral opioid antagonist approved for this indication in the US.
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...