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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 • 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...
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 • March 12, 2018 (Issue 1542)
View the Comparison Table: Some Oral 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)
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...