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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)
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...
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 23, 2018 (Issue 1545)
The FDA has approved the sodium-glucose co-transporter 2 (SGLT2) inhibitor ertugliflozin (Merck) for treatment of adults with type 2 diabetes, both alone (Steglatro) and in fixed-dose combinations with metformin (Segluromet) and sitagliptin (Steglujan). Ertugliflozin is the fourth SGLT2 inhibitor to be approved in the US. All four are available in combination with metformin...
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 • 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)
Antiviral drugs can be used for treatment and prophylaxis of influenza. Frequently updated information on influenza activity, testing for influenza, and antiviral resistance is available from the CDC at www.cdc.gov/flu.
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 • November 6, 2017 (Issue 1533)
The FDA has approved Duzallo (Ironwood), a fixed-dose combination of the uric acid transporter 1 (URAT1) inhibitor lesinurad (Zurampic) and the xanthine oxidase inhibitor allopurinol (Zyloprim, and generics), for once-daily treatment of gout-associated hyperuricemia in patients who have not achieved target serum uric acid levels with allopurinol alone.
The Medical Letter on Drugs and Therapeutics • November 6, 2017 (Issue 1533)
The FDA has approved the interleukin (IL)-23 blocker guselkumab (Tremfya – Janssen) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Guselkumab is the first selective IL-23 blocker to become available in the US.
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)
Routine annual vaccination against influenza A and B viruses is recommended for everyone ≥6 months old without a specific contraindication.
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)
The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has...