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The Medical Letter on Drugs and Therapeutics • June 18, 2018 (Issue 1549)
The FDA has approved the HMG-CoA reductase inhibitor (statin) pitavastatin magnesium (Zypitamag – Zydus) for use in adults with primary hyperlipidemia or mixed dyslipidemia. The FDA considers pitavastatin magnesium bioequivalent to pitavastatin calcium (Livalo), which was approved in 2009.1

Statins remain the treatment of choice...
The Medical Letter on Drugs and Therapeutics • June 18, 2018 (Issue 1549)
The FDA has approved Admelog (Sanofi-Aventis), an insulin lispro product similar to Humalog (Lilly), which went off patent in 2013.

Approval of Admelog was based on efficacy data with Humalog and on two 6-month, open-label, randomized, noninferiority trials. In SORELLA 11 in 507 patients with type 1 diabetes and...
The Medical Letter on Drugs and Therapeutics • May 21, 2018 (Issue 1547)
Essure (Bayer) is the only nonsurgical, permanent contraceptive available in the US. The coil-like devices are placed hysteroscopically in both fallopian tubes and, after several months, scar tissue causes tubal occlusion.1 In 2016, the FDA required Bayer to revise the device's labeling to include a patient decision checklist and a boxed warning...
The Medical Letter on Drugs and Therapeutics • May 21, 2018 (Issue 1547)
The FDA has approved a lower-dose epinephrine auto-injector (Auvi-Q 0.1 mg – Kaléo) for emergency treatment of anaphylaxis in children weighing 7.5-15 kg (16.5-33 lbs). It is the first epinephrine auto-injector to be approved for use in infants and toddlers weighing less than 15 kg. Previously, Auvi-Q and other epinephrine auto-injectors were only available in 0.15- and 0.3-mg...
The Medical Letter on Drugs and Therapeutics • April 9, 2018 (Issue 1544)
In issue 1540 on nonopioid drugs for pain (Med Lett Drugs Ther 2018; 60:24), we said that nonacetylated salicylates such as diflunisal and salsalate do not interfere with platelet aggregation. That is not entirely true for diflunisal. Although low doses (250 mg twice daily) of diflunisal have no effect on platelets and the usual dosage of 500 mg...
The Medical Letter on Drugs and Therapeutics • March 12, 2018 (Issue 1542)
View the Comparison Table: Some Parenteral Anticoagulants for VTE
The Medical Letter on Drugs and Therapeutics • January 29, 2018 (Issue 1539)
The FDA has approved a two-dose hepatitis B virus (HBV) vaccine (Heplisav-B – Dynavax) for use in adults ≥18 years old. The three other HBV vaccines marketed in the US are usually administered in 3 doses. Engerix-B and Recombivax HB are licensed for use in persons of all ages. A combination hepatitis A/B vaccine (Twinrix) contains the same hepatitis B component as...
The Medical Letter on Drugs and Therapeutics • January 29, 2018 (Issue 1539)
A reader asked whether healthcare providers should avoid prescribing the angiotensin receptor blocker (ARB) olmesartan medoxomil (Benicar, and others) because it can cause severe GI adverse effects.

In 2013, the FDA warned that olmesartan can cause sprue-like enteropathy, a condition characterized by intestinal villous atrophy, severe chronic diarrhea, and significant...
The Medical Letter on Drugs and Therapeutics • January 29, 2018 (Issue 1539)
The FDA has warned that the IV emulsion formulation of the substance P/neurokinin 1 (NK1) receptor antagonist rolapitant (Varubi) has been associated in postmarketing reports with serious hypersensitivity reactions including anaphylaxis and anaphylactic shock.1 Rolapitant was approved by the FDA as an oral tablet in 2015 for adjunctive prevention of...
The Medical Letter on Drugs and Therapeutics • January 1, 2018 (Issue 1537)
The immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, has been granted accelerated approval by the FDA for use in adults and children who have unresectable or metastatic microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) solid tumors that have progressed following treatment, and do not have any...
The Medical Letter on Drugs and Therapeutics • December 4, 2017 (Issue 1535)
New US guidelines for the treatment of hypertension have recently been published.1

Probably the most important change from previous guidelines2 is that use of blood pressure-lowering medication is now recommended for secondary prevention in patients with cardiovascular disease and an average systolic blood...
The Medical Letter on Drugs and Therapeutics • October 23, 2017 (Issue 1532)
In our article on Drugs for Cognitive Loss and Dementia (Med Lett Drugs Ther 2017; 59:155), the last sentence at the end of the article should have been omitted. It has been deleted from the article online.
The Medical Letter on Drugs and Therapeutics • October 9, 2017 (Issue 1531)
Pancreatic enzyme replacement products have been used for years to improve digestion in patients with exocrine pancreatic insufficiency (EPI). These products were initially marketed before formal FDA approval was required; in 1991, however, the FDA told all manufacturers of pancreatic enzyme replacement products that they would have to submit a new drug application by April 2010 in order to keep...
The Medical Letter on Drugs and Therapeutics • September 11, 2017 (Issue 1529)
In Table 3 on page 116 (Med Lett Drugs Ther 2017; 59:113), the price provided for Prevpac was for a 14-day supply, rather than for a 10-day supply as stated in footnote 1. The footnote has been corrected and the price of the generic formulation of Prevpac has been added.
The Medical Letter on Drugs and Therapeutics • August 14, 2017 (Issue 1527)
The FDA has approved the oral multikinase inhibitor midostaurin (Rydapt – Novartis) for first-line treatment, in addition to standard chemotherapy, of adults with FLT3 (fms-like tyrosine kinase 3) mutation-positive acute myeloid leukemia (AML). About 30% of patients with AML have FLT3 mutations. Midostaurin is also approved as a single agent for treatment of adults with aggressive...
The Medical Letter on Drugs and Therapeutics • July 17, 2017 (Issue 1525)
The FDA has approved the fully-human programmed death ligand 1 (PD-L1) blocking antibody avelumab (Bavencio – EMD Serono/Pfizer) for treatment of metastatic Merkel cell carcinoma (MCC) in patients ≥12 years old. Avelumab is the first drug to be approved in the US for this rare skin cancer. About 1600 people in the US, most commonly older adults (mean age at presentation is 75 years), are...
The Medical Letter on Drugs and Therapeutics • June 5, 2017 (Issue 1522)
Opioid use disorder is a chronic, relapsing disease with both physical and psychiatric components. It is associated with economic hardship, social isolation, incarceration, increased rates of blood-borne infections such as HIV and viral hepatitis, adverse pregnancy outcomes, and increased mortality. According to the CDC, there were 33,091 deaths related to opioid overdose in the US in 2015, more...
The Medical Letter on Drugs and Therapeutics • June 5, 2017 (Issue 1522)
View Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder
The Medical Letter on Drugs and Therapeutics • May 22, 2017 (Issue 1521)
Per capita spending on prescription drugs in the US is higher than in other industrialized nations, including Canada.
The Medical Letter on Drugs and Therapeutics • April 24, 2017 (Issue 1519)
The FDA has warned that eluxadoline (Viberzi – Allergan), a mu-opioid receptor agonist and delta-opioid receptor antagonist approved in 2015 for treatment of irritable bowel syndrome with diarrhea (IBS-D),1 should not be used in patients without a gallbladder because of an increased risk of serious pancreatitis.2...