The FDA has warned that use of the macrolide antibiotic clarithromycin (Biaxin, and generics) may increase the risk of cardiovascular morbidity and mortality in patients with heart disease.

A 0.24% ophthalmic solution of the second-generation H₁-antihistamine cetirizine (Zerviate – Eyevance) is now available by prescription for treatment of ocular itching associated with allergic conjunctivitis in patients ≥2 years old. Oral cetirizine (Zyrtec, and others), which is used for treatment of allergic conjunctivitis and rhinitis, has been available over the counter (OTC) for years.

A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.

An inhalation aerosol formulation of the corticosteroid fluticasone propionate (Flovent -Glaxo Wellcome) has been approved by the US Food and Drug Administration for maintenance treatment of asthma.

The FDA has approved the marketing of loratadine (Claritin - Schering), a second-generation H₁-antihistamine, without a prescription. The drug was also recently approved for OTC use as Alavert (Wyeth) and other generics are expected.

Because of concerns about the possibility of bioterrorism involving smallpox, the US government is reinstituting smallpox vaccination (https://www.cdc.gov/smallpox/; www.idsociety.org/bt/toc.htm). Vaccination is currently expected to proceed in three phases: the military and hospital smallpox response teams first, other health care workers, police and firefighters second, and the general public in the third phase. Except for the military, vaccination will be...

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

Atopic dermatitis (AD; also known as eczema) is frequently associated with other atopic disorders such as allergic rhinitis, asthma, and food allergy. It commonly presents in infancy and early childhood and has a relapsing course, often improving by adolescence, but sometimes persisting into (or first appearing in) adulthood or even old age.

The FDA is requiring a new warning in the prescription and over-the-counter labels of the oral second-generation H₁-antihistamines cetirizine (Zyrtec, and others) and levocetirizine (Xyzal, and others) about the risk of severe pruritus following discontinuation of treatment.

In the past 2 years, the FDA has approved 3 new drugs for prevention or treatment of hereditary angioedema (HAE) in non-pregnant adolescents and adults: the C1 esterase inhibitor Cinryze for prophylaxis and the C1 esterase inhibitor Berinert and the kallikrein inhibitor ecallantide (Kalbitor) for treatment of acute attacks.