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The Medical Letter on Drugs and Therapeutics • March 25, 2019 (Issue 1568)
The FDA has approved changes to the labeling of erenumab-aooe (Aimovig)1, a once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) blocker approved in 2018 for prevention of migraine. The new label contains a warning about hypersensitivity reactions, including rash, angioedema, and anaphylaxis, that have been reported with post-...
The Medical Letter on Drugs and Therapeutics • February 25, 2019 (Issue 1566)
Patients may ask about taking elderberry for prevention and treatment of influenza. Products containing elderberry are promoted for relief of cold and flu symptoms and as an immune system booster.
The Medical Letter on Drugs and Therapeutics • January 14, 2019 (Issue 1563)
The FDA has approved the subcutaneously injected monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of patients ≥12 years old with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupilumab was approved earlier to treat adults with moderate to severe atopic dermatitis inadequately controlled...
The Medical Letter on Drugs and Therapeutics • January 14, 2019 (Issue 1563)
View the Expanded Table: Antiviral Drugs for Seasonal Influenza
The Medical Letter on Drugs and Therapeutics • December 3, 2018 (Issue 1561)
Some readers have questioned our characterization of opioid withdrawal as not life-threatening (Med Lett Drugs Ther 2018; 60:137). While death during opioid withdrawal is unusual, it is possible — for example, due to severe untreated dehydration, withdrawal-induced suicidality, or rare myocardial events. We probably should have said that opioid...
The Medical Letter on Drugs and Therapeutics • November 19, 2018 (Issue 1560)
Persons planning to travel outside the US should be up to date on routine vaccines and, depending on their destination, duration of travel, and planned activities, may also receive certain travel-specific vaccines. Tickborne encephalitis and dengue vaccines, which are not available in the US, are reviewed in a separate article available online. Detailed advice for travel to specific destinations...
The Medical Letter on Drugs and Therapeutics • November 19, 2018 (Issue 1560)
View the Expanded Table: Some Vaccines for Travelers
The Medical Letter on Drugs and Therapeutics • November 19, 2018 (Issue 1560)
No vaccines against tickborne encephalitis (TBE) or dengue are available in the US, but vaccines have been licensed in some other countries.
The Medical Letter on Drugs and Therapeutics • November 5, 2018 (Issue 1559)
The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK inhibitor to be approved for this indication; ibrutinib (Imbruvica) was approved in 2013.

Ibrutinib inhibits other kinases in addition to BTK and has been associated...
The Medical Letter on Drugs and Therapeutics • October 22, 2018 (Issue 1558)
Routine annual vaccination against influenza A and B viruses is recommended for everyone ≥6 months old. Recommendations for the current season for specific patient populations are listed in Tables 2 and 4.
The Medical Letter on Drugs and Therapeutics • September 24, 2018 (Issue 1556)
The FDA has approved hydrogen peroxide 40% topical solution (Eskata – Aclaris Therapeutics) for treatment of raised seborrheic keratoses (SKs) in adults. It is the first drug to be approved for this indication. (Hydrogen peroxide is available over the counter for topical use as a 3% solution.)
The Medical Letter on Drugs and Therapeutics • September 10, 2018 (Issue 1555)
The FDA has approved an estradiol softgel vaginal insert (Imvexxy – TherapeuticsMD) for treatment of postmenopausal women with moderate to severe dyspareunia due to vulvovaginal atrophy (VVA). Imvexxy is the second estradiol vaginal insert to be approved in the US; Vagifem, an intravaginal tablet formulation, was the first. Vagifem and Imvexxy are both available...
The Medical Letter on Drugs and Therapeutics • August 27, 2018 (Issue 1554)
The FDA has approved a single-injection hyaluronic acid gel (Durolane – Bioventus) and an extended-release (ER) formulation of the synthetic corticosteroid triamcinolone acetonide (Zilretta – Flexion) for intra-articular (IA) treatment of osteoarthritic knee pain.
The Medical Letter on Drugs and Therapeutics • August 13, 2018 (Issue 1553)
The FDA has required changes in the labeling of all systemic fluoroquinolone antibiotics to strengthen warnings about the risk of severe hypoglycemia and mental health effects associated with their use.1

An FDA review identified 67 cases of hypoglycemic coma associated with fluoroquinolone use, 22 of which resulted in death or disability. Most...
The Medical Letter on Drugs and Therapeutics • August 13, 2018 (Issue 1553)
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but some questions remain about their effectiveness and safety.
The Medical Letter on Drugs and Therapeutics • August 13, 2018 (Issue 1553)
The FDA has approved a 6% otic suspension formulation of the fluoroquinolone antibiotic ciprofloxacin (Otiprio – Otonomy) for single-dose treatment of acute otitis externa (swimmer's ear) caused by Pseudomonas aeruginosa or Staphylococcus aureus in patients ≥6 months old. Otiprio was approved earlier for prophylaxis in children with bilateral otitis media with...
The Medical Letter on Drugs and Therapeutics • July 16, 2018 (Issue 1551)
In our article on abuse-deterrent opioids (Med Lett Drugs Ther 2017; 59:95), the information on Targiniq ER in Table 1 is incorrect. The drug, which is not available in the US, is a combination of oxycodone ER and naloxone, not naltrexone, and naloxone is dispersed throughout the tablet, not sequestered. Targiniq ER will be deleted...
The Medical Letter on Drugs and Therapeutics • June 18, 2018 (Issue 1549)
Coagulation factor Xa (recombinant), inactivated-zhzo (andexanet alfa; Andexxa – Portola) has received accelerated approval from the FDA for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto). Andexanet alfa is the second antidote for a direct oral anticoagulant to become available in the US, and the fi...
The Medical Letter on Drugs and Therapeutics • June 18, 2018 (Issue 1549)
The FDA has warned that the antiepileptic and mood-stabilizing drug lamotrigine (Lamictal, and generics) can rarely cause hemophagocytic lymphohistiocytosis (HLH), a serious and potentially fatal immune-related reaction.1

HLH, which can be familial, occurs most often in infants, but can occur at any age. Often induced by Epstein-Barr Virus...
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...