FluMist (AstraZeneca), the live-attenuated intranasal influenza vaccine that has been available for years for administration by a healthcare provider in nonpregnant persons 2-49 years old, has now been approved by the FDA for self- or caregiver-administration. It is expected to be available for such use during the 2025-2026 influenza season. FluMist is only available through a healthcare provider this season. It will continue to be available for administration by a healthcare provider in the future

The FDA has approved deutetrabenazine (Austedo – Teva), a vesicular monoamine transporter 2 (VMAT2) inhibitor, for treatment of chorea associated with Huntington's disease and, more recently, for treatment of tardive dyskinesia in adults. It is the second VMAT2 inhibitor to be approved for each of these indications; tetrabenazine (Xenazine, and generics) was approved earlier for Huntington's chorea and valbenazine (Ingrezza) was recently approved for treatment of adults with tardive dyskinesia.

Becaplermin (be kap' ler min; Regranex - Ortho-McNeil), a 0.01% topical gel formulation of recombinant human platelet-derived growth factor (rhPDGF), was recently approved by the FDA for adjunctive treatment of diabetic ulcers of the lower extremities that extend subcutaneously or beyond and have an adequate blood supply. Endogenous platelet-derived growth factor increases proliferation of cells that repair wounds and form granulation tissue.

The FDA has approved icatibant (Firazyr – Shire), a selective bradykinin B2 receptor antagonist, for treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare autosomal dominant disorder (estimated prevalence 1:10,000-50,000) in which patients experience recurrent and frequently unpredictable attacks of angioedema lasting 2-5 days, typically involving the extremities, gastrointestinal tract, genitalia, face, oropharynx or larynx. Laryngeal edema may be life-threatening. HAE is usually caused by a mutation of the C1-inhibitor (C1-INH) gene. C1-INH is a serine proteinase...

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.2As of February 2017, the FDA had received reports of 118 cases of serious, nonfatal pancreatitis and 2 deaths associated with use of eluxadoline. Both deaths occurred in patients without a gallbladder who developed severe abdominal pain and vomiting shortly after taking the first...

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.1HLH, which can be familial, occurs most often in infants, but can occur at any age. Often induced by Epstein-Barr Virus infection (HIV infection and non-Hodgkin's lymphoma are other common triggers), HLH is characterized by an unremitting activation of CD8+ T cells and macrophages.2 If untreated, it causes organ damage, particularly in the liver, bone marrow, and CNS; organ...

Smoking tobacco remains the primary preventable cause of death in the US. Smoking cessation often requires both pharmacotherapy and behavioral support.

Ofloxacin (Floxin - McNeil, Ortho), a new fluoroquinolone antibacterial agent, was recently marketed in the USA for oral treatment of various infections caused by susceptible microorganisms. Ofloxacin is the third fluoroquinolone to become available in this country. Norfloxacin (Noroxin - Medical Letter, 29:25, 1987) is marketed only for treatment of urinary tract infections. Ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), like ofloxacin, is approved for use in a variety of infections.

Salmeterol xinafoate (Serevent - Allen & Hanburys), a long-acting β 2 -selective adrenergic agonist for inhalation, has been approved by the US Food and Drug Administration for maintenance treatment of asthma, with or without concurrent use of inhaled corticosteroids. Salmeterol is not recommended for acute treatment of bronchospasm.

immune globulin (human) has been available for many years in an intramuscular (IM) formulation for prevention of Rh isoimmunization in pregnant Rh-negative women (Medical Letter, 16:3, 1974). Recently, the US Food and Drug Administration (FDA) approved the first intravenous (IV) immune globulin preparation (WinRho SD - Univax), not only for preventing Rh isoimmunization, but also for treatment of immune thrombocytopenic purpura (ITP) in Rh-positive patients.