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The Medical Letter on Drugs and Therapeutics • February 6, 2012 (Issue 1383)
Nexplanon (Merck), a modified version of the contraceptive implant Implanon (Merck), is now available in the US. Nexplanon contains 68 mg of the progestin etonogestrel and is bioequivalent to Implanon. Both products are single-rod subdermal contraceptives implanted into the inside of the upper arm; both provide reversible effective contraception for up to 3...
The Medical Letter on Drugs and Therapeutics • January 23, 2012 (Issue 1382)
A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in 8606 patients with type 2 diabetes and renal impairment (ALTITUDE) was terminated prematurely by the manufacturer because the combined incidence of cardiovascular and renal...
The Medical Letter on Drugs and Therapeutics • January 9, 2012 (Issue 1381)
An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who are not on dialysis. The FDA itself is expected to make a decision on this potential new indication in the first quarter of 2012.

The manufacturer’s application for this new indication was...
The Medical Letter on Drugs and Therapeutics • December 12, 2011 (Issue 1379)
The FDA has announced that Eli Lilly has voluntarily withdrawn drotrecogin alfa (activated) (Xigris) after a recently completed trial (PROWESS-SHOCK) in patients with severe sepsis and septic shock failed to show an increase in survival in those treated with the drug.1 Drotrecogin alfa is a recombinant form of human activated protein C. Native activated protein C...
The Medical Letter on Drugs and Therapeutics • November 28, 2011 (Issue 1378)
The FDA has approved icatibant (Firazyr – Shire), a selective bradykinin B2 receptor antagonist, for treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare autosomal dominant disorder (estimated prevalence 1:10,000-50,000) in which patients experience recurrent and frequently unpredictable attacks of angioedema lasting 2-5 days, typically involving the extremities,...
The Medical Letter on Drugs and Therapeutics • November 14, 2011 (Issue 1377)
A recent editorial in The New England Journal of Medicine commented on the negative results of a clinical trial (published in the same issue) of nesiritide, a drug that had been approved by the FDA in 2001 (conditionally approved by Health Canada in 2007) for relief of dyspnea in patients with acutely decompensated heart failure. The authors of the recent clinical trial concluded: "On...
The Medical Letter on Drugs and Therapeutics • October 31, 2011 (Issue 1376)
The surprising observation that oral administration of the beta-blocker propranolol (Inderal, and others) can stop the growth and rapidly cause the involution of disfiguring or life-threatening infantile hemangiomas1 has quickly led to a series of confirmatory observations and now a controlled trial. The mechanism of this effect is not known, but is thought to be...
The Medical Letter on Drugs and Therapeutics • October 17, 2011 (Issue 1375)
A reader has asked us to review the use of propofol (Diprivan, and others) as a sedative agent for brief procedures, such as colonoscopy.

First marketed more than 20 years ago,1 propofol has a rapid onset of action (patients usually lose consciousness in less then one minute) and a short duration of action with a rapid recovery (3-5 minutes) that makes it...
The Medical Letter on Drugs and Therapeutics • October 3, 2011 (Issue 1374)
The FDA and two of its advisory committees have been debating whether to recommend limiting the duration of use of bisphosphonates in order to prevent atypical femoral fractures and possibly other side effects of the drugs. The agency produced a 182-page background document on this subject for a joint meeting of the Reproductive Health Drugs and the Drug Safety and Risk Management Advisory...
The Medical Letter on Drugs and Therapeutics • August 22, 2011 (Issue 1371)
Varenicline (Chantix), which has been associated with neuropsychiatric symptoms such as agitation, depressed mood, changes in behavior and suicidal ideation, appears to be the most effective drug available for treatment of tobacco dependence.1 Recently, the FDA warned that varenicline may also increase the risk of cardiovascular adverse events in patients with...
The Medical Letter on Drugs and Therapeutics • June 13, 2011 (Issue 1366)
A randomized, placebo-controlled, double-blind trial of exemestane (Aromasin, and others) in postmenopausal women considered at increased risk for breast cancer found that the aromatase inhibitor, over a median follow-up of 35 months, significantly decreased the annual incidence of invasive breast cancer from 0.55% to 0.19% (PE Goss et al. N Engl J Med, epub June 4, 2011).
The Medical Letter on Drugs and Therapeutics • May 30, 2011 (Issue 1365)
Fexofenadine (Allegra, and others) is the most recent second-generation H1-antihistamine to become available over the counter (OTC). Cetirizine (Zyrtec, and others) and loratadine (Claritin, and others) are already available OTC. Cetirizine can be sedating in usual doses. Loratadine can be sedating in higher-than-usual doses. Fexofenadine remains nonsedating...
The Medical Letter on Drugs and Therapeutics • May 16, 2011 (Issue 1364)
Evidence of waning immunity by 5 years post-vaccination has led the US Advisory Committee on Immunization Practices (ACIP) to recommend, in addition to a primary dose of meningococcal conjugate vaccine at 11 or 12 years of age, a booster dose at age 16. Adolescents who receive a first dose of the vaccine at age 13-15 should receive a booster dose at 16-18 (before college). Those who receive their...
The Medical Letter on Drugs and Therapeutics • May 16, 2011 (Issue 1364)
The FDA has approved the marketing of fentanyl sublingual tablets (Abstral – ProStrakan) for treatment of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. It is the fourth transmucosal formulation of fentanyl to become available in the US for this indication.1-3

The manufacturer recommends an initial...
The Medical Letter on Drugs and Therapeutics • April 18, 2011 (Issue 1362)
A recent article in Circulation reported that acetaminophen (Tylenol, and others; paracetamol outside the US) increased blood pressure in patients with coronary artery disease. This conclusion was based on a randomized, placebo-controlled crossover trial in 33 patients; acetaminophen 1 g three times daily for 2 weeks was associated with statistically significant increases in...
The Medical Letter on Drugs and Therapeutics • April 4, 2011 (Issue 1361)
The FDA has warned that prolonged use of a proton pump inhibitor (PPI) can lead to hypomagnesemia.1 Normal serum concentrations of magnesium are 0.7-1.0 mmol/L. About 30 cases of severe hypomagnesemia (<0.5 mmol/L) have been reported in long-term PPI users; when the PPI was stopped, serum magnesium levels returned to normal in less than 2 weeks.2-5...
The Medical Letter on Drugs and Therapeutics • April 4, 2011 (Issue 1361)
The FDA has approved aliskiren/amlodipine/hydrochlorothiazide (Amturnide) for treatment of hypertension, with no restrictions except that it should not be used for initial therapy. A combination of the direct renin inhibitor aliskiren and the calcium channel blocker amlodipine (Tekamlo) was approved earlier for initial treatment.1

Use of...
The Medical Letter on Drugs and Therapeutics • March 21, 2011 (Issue 1360)
A new enteric-coated delayed-release formulation of risedronate (Atelvia – Warner Chilcott) has been approved by the FDA for treatment of postmenopausal osteoporosis. Unlike immediate-release risedronate (Actonel) and all other oral bisphosphonates, which must be taken after an overnight fast and at least 30 minutes before eating breakfast, the new formulation is taken...
The Medical Letter on Drugs and Therapeutics • March 7, 2011 (Issue 1359)
The FDA and the manufacturer (Sanofi-Aventis) have warned healthcare professionals that use of dronedarone (Multaq), an analog of amiodarone (Cordarone, and others) approved in 2009 for treatment of atrial fibrillation,1,2 has been associated with "several" cases of severe liver injury and hepatic failure, including two that required liver transplants. Both...
The Medical Letter on Drugs and Therapeutics • March 7, 2011 (Issue 1359)
The FDA has approved a new indication for prevention of anal cancer and anal intraepithelial neoplasia in both sexes for the human papillomavirus (HPV) vaccine Gardasil (Merck). This vaccine is already FDA-approved for prevention of cervical cancer and genital warts in females 9-26 years old and for prevention of genital warts in males 9-26 years old. HPV types 6 and 11 cause about 90%...