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The Medical Letter on Drugs and Therapeutics • October 13, 2014 (Issue 1453)
The US Advisory Committee on Immunization Practices (ACIP) now recommends routine immunization with 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13), in addition to the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax 23), for all adults ≥65 years old.1

An unpublished, randomized, double-blind trial (...
The Medical Letter on Drugs and Therapeutics • September 1, 2014 (Issue 1450)
Wild poliovirus has circulated during the previous 12 months in Cameroon, Equatorial Guinea, Ethiopia, Iraq, Israel (also the West Bank and Gaza), Somalia, and Syria, as well as in those countries where polio is still endemic (Afghanistan, Nigeria, and Pakistan). The World Health Organization (WHO) has declared a public health emergency related to the possible spread of polio from affected...
The Medical Letter on Drugs and Therapeutics • July 21, 2014 (Issue 1447)
The FDA has approved the proton pump inhibitor (PPI) esomeprazole strontium for use in adults for the same indications as esomeprazole magnesium (Nexium): treatment of gastroesophageal reflux disease (GERD), prevention of NSAID-induced gastric ulcers, eradication of Helicobacter pylori, and treatment of pathological hypersecretory conditions. It was first marketed in December...
The Medical Letter on Drugs and Therapeutics • July 21, 2014 (Issue 1447)
The FDA has authorized two manufacturers (Teva, Mylan) to market generic formulations of celecoxib (Celebrex – Pfizer), the only COX-2 selective inhibitor remaining on the US market. Celecoxib is less likely than nonselective NSAIDs to cause gastric ulcers or other GI toxicity,1 and unlike traditional NSAIDs, it does not have an antiplatelet effect...
The Medical Letter on Drugs and Therapeutics • July 21, 2014 (Issue 1447)
The same pharmaceutical company (Iroko) that recently marketed low-dose diclofenac (Zorvolex) for treatment of mild to moderate acute pain1 has now received approval from the FDA to market a low-dose oral formulation of indomethacin (Tivorbex) for the same indication. Tivorbex is available in 20- and 40-mg capsules; conventional...
The Medical Letter on Drugs and Therapeutics • June 9, 2014 (Issue 1444)
A recent Medical Letter article reported renewed interest in the intranasal administration (off-label) of the opioid antagonist naloxone because of an increase in deaths from opioid overdose in the US.1 Now the FDA has approved a more practical alternative for emergency treatment of life-threatening opioid overdose in adults and children: a single-dose...
The Medical Letter on Drugs and Therapeutics • June 9, 2014 (Issue 1444)
The FDA has required the manufacturer of eszopiclone (Lunesta – Sunovion), a benzodiazepine receptor agonist approved for the treatment of insomnia, to lower the current recommended starting dose to 1 mg for both men and women because a new study found that an evening dose of 3 mg can impair driving skills, memory, and coordination for more than 11 hours....
Treatment Guidelines from The Medical Letter • June, 2014 (Issue 142)
Vaccines recommended for adults residing in the US are reviewed here. Vaccines for travel have been reviewed separately.

Eight vaccines are currently recommended by the US Advisory Committee on Immunization Practices (ACIP) for routine use in adults at various ages...
The Medical Letter on Drugs and Therapeutics • May 26, 2014 (Issue 1443)
The FDA has approved the use of an equine heptavalent botulism antitoxin (BAT, Cangene Corporation). The new antitoxin includes antibodies against all 7 botulinum neurotoxin types (A-G). A human-derived antitoxin (BabyBIG) has been available for years for infant botulism. The heptavalent product is now the preferred antitoxin for adult botulism. It is a solution of immunoglobulin fragments...
The Medical Letter on Drugs and Therapeutics • April 28, 2014 (Issue 1441)
One of our readers has suggested that more attention should have been paid to a study comparing the antiplatelet effects of immediate-release and enteric-coated aspirin that appeared in Circulation last year.1 The safety benefits of enteric-coated aspirin are unclear. It may protect against dyspepsia, but not against major gastrointestinal bleeding...
The Medical Letter on Drugs and Therapeutics • March 31, 2014 (Issue 1439)
The FDA has approved a new injectable formulation of methotrexate (Otrexup – Antares) for use in rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and for severe psoriasis in adults. On its web site (www.otrexup.com), the manufacturer states: "Otrexup is the first subcutaneous (SC) methotrexate (MTX...
The Medical Letter on Drugs and Therapeutics • March 3, 2014 (Issue 1437)
Prompted by the recent publication of 2 retrospective studies, the FDA has announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.1

The first study examined the records of 8709 men with low testosterone levels (<300 ng/dL) who underwent coronary angiography between 2005...
The Medical Letter on Drugs and Therapeutics • February 3, 2014 (Issue 1435)
The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of restrictions was based on the results of an independent reevaluation of the RECORD trial, which found no significant difference between rosiglitazone and metformin/sulfonylurea in the...
The Medical Letter on Drugs and Therapeutics • January 20, 2014 (Issue 1434)
The October 2013 suspension of marketing and sales of ponatinib (Iclusig – Ariad) for treatment of leukemia1 has been lifted by the FDA, and the drug is expected to return to the market this month with narrower indications and heightened safety warnings.2 The reason for its suspension was a high incidence of thrombotic events, some of them...
The Medical Letter on Drugs and Therapeutics • January 6, 2014 (Issue 1433)
Anticoagulants are the drugs of choice for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE).
The Medical Letter on Drugs and Therapeutics • January 6, 2014 (Issue 1433)
The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for treatment of depression. It is the third extended-release formulation of desvenlafaxine to become available in the US. Khedezla was approved using a 505(b)(2) application, a new drug application (NDA...
The Medical Letter on Drugs and Therapeutics • December 9, 2013 (Issue 1431)
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 use (at Princeton University only) of a meningococcus B vaccine (4CMenB; Bexsero – Novartis) that has not been approved in the US. Bexsero has been approved for use in the European...
The Medical Letter on Drugs and Therapeutics • November 25, 2013 (Issue 1430)
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 of life-threatening blood clots and severe narrowing of blood vessels.1 Ponatinib is a tyrosine kinase inhibitor that was granted accelerated approval by the FDA in December 2012...
The Medical Letter on Drugs and Therapeutics • November 25, 2013 (Issue 1430)
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 discoloration, all of which could be permanent.1

Ezogabine was approved in 2011 for adjunctive treatment of partial-onset seizures in adults.2 The FDA first...
The Medical Letter on Drugs and Therapeutics • November 11, 2013 (Issue 1429)
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 and on the Internet, their use has been increasing over recent years, primarily among smokers, but also among non-smokers.