The FDA has approved over-the-counter (OTC) sale of inhaled epinephrine (Primatene Mist – Amphastar), a nonselective alpha and beta agonist, for temporary relief of mild symptoms of intermittent asthma in patients ≥12 years old who have been diagnosed with mild intermittent asthma by a healthcare professional. The original version of Primatene Mist, which was approved by the FDA in 1967, was removed from the market in 2011 because the metered-dose inhaler (MDI) contained ozone-depleting chlorofluorocarbon (CFC) propellants; the new MDI contains hydrofluoroalkane (HFA)...

The short-acting beta2-agonist albuterol sulfate has recently become available as a large-volume (20 mL), preservative-free concentrate (albuterol inhalation solution 0.5% – Nephron Pharmaceuticals) that can be used to prepare solutions for administration of continuous nebulized albuterol (CNA). CNA is commonly used (off-label) for acute treatment of severe asthma exacerbations in hospitalized patients, particularly children. Many hospitals have been using a 20-mL multidose bottle of 0.5% albuterol that contains the preservative benzalkonium chloride (BAC) for this purpose. Until...

The FDA is requiring stronger warnings in the labeling of the leukotriene receptor antagonist montelukast (Singulair, and generics) about the risk of suicidal behavior and other serious neuropsychiatric events associated with its use.

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.

A little more than a year ago, The Medical Letter reported the results of an FDA meta-analysis which found that use of a long-acting beta-2 agonist (LABA) such as salmeterol (Severent) or formoterol (Foradil) in patients with asthma was associated with an increased risk of a composite endpoint of asthma-related death, intubation or hospitalization; the highest risk was in children 4-11 years old.There was no significant increase in risk when a long-acting beta-2 agonist was used with an inhaled corticosteroid.The Medical Letter recommended that long-acting beta-2 agonists should not be used as...

Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used off-label for treatment of allergic rhinitis and food allergies. Recently the results of a phase III clinical trial indicated that omalizumab may be effective in treating chronic urticaria as well.

The FDA has approved lebrikizumab-lbkz (Ebglyss – Lilly), a subcutaneously injected interleukin (IL)-13 antagonist, for treatment of moderate to severe atopic dermatitis that has not been or cannot be adequately treated with topical therapy in patients ≥12 years old (weight ≥40 kg). Lebrikizumab is the third subcutaneously injected human IgG4 monoclonal antibody to be approved in the US for this indication. Tralokinumab (Adbry), another IL-13 antagonist, is also approved for use in patients ≥12 years old, and dupilumab (Dupixent), an IL-4 and IL-13 inhibitor, is approved for...

The FDA has approved Odactra (ALK), a sublingual allergen extract, for immunotherapy in adults 18-65 years old with house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis. Odactra is the first sublingual allergen extract to be approved in the US for this indication. Three other sublingual allergen extracts were approved earlier (see Table 1).

In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and others) in many OTC formulations when access to pseudoephedrine-containing products was restricted in an effort to reduce their use in the synthesis of methamphetamine.CLINICAL STUDIES — In a randomized, open-label,...

The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same indication.