The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of migraine in adults. Now the FDA has added a new warning to its labeling about a risk of new-onset hypertension and worsening of preexisting hypertension associated with use of the drug. CGRP is a potent microvascular vasodilator; blocking or deleting it has produced hypertensive effects in animals.

The FDA has approved release of omalizumab (oh mah lye zoo mab; Xolair - Genentech, Novartis), a humanized monoclonal antibody given subcutaneously that binds to immunoglobulin E (IgE). The drug is labeled for patients at least 12 years old with moderate to severe persistent asthma who have shown reactivity to an allergen and whose symptoms are inadequately controlled by an inhaled corticosteroid. The manufacturer claims the drug can help stop allergic reactions before they begin.

The FDA recently approved the monoamine oxidase inhibitor (MAOI) selegiline in a transdermal (patch) formulation (Emsam - Bristol-Myers Squibb/Somerset) for treatment of major depressive disorder. Selegiline is also available in an oral formulation (Eldepryl, and others) for treatment of Parkinson's disease.

The FDA has approved ThermaClear (Therative), a battery-powered, handheld device, to treat individual acne lesions with heat. ThermaClear is indicated only for use on mild to moderate inflammatory acne, not severe nodular or severe cystic acne, and it is not meant to be used on blackheads and whiteheads. Two similar devices are already on the market: Zeno, another handheld device that delivers heat to acne lesions, and the Radiancy Clear Touch Lite Acne Clearance System, a larger heat-delivery device.

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The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of methotrexate. Ruxolitinib (Jakafi) is the only other JAK inhibitor available in the US; it is FDA-approved for treatment of myelofibrosis.

Olodaterol (Striverdi Respimat – Boehringer Ingelheim), a new inhaled long-acting beta2-agonist, has been approved by the FDA for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Olodaterol is the third long-acting beta2-agonist to be approved by the FDA for once-daily use; indacaterol (Arcapta Neohaler), which is available as a single agent, and vilanterol, which is available only in fixed-dose combinations with the...

The FDA has approved ivabradine (Corlanor – Amgen) to reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35% who are in sinus rhythm with a resting heart rate ≥70 beats per minute and who are on maximum tolerated doses of beta blockers or have a contraindication to beta blocker use. Ivabradine has been available internationally for years as Procoralan and Corlentor for treatment of stable angina and heart failure.

A new CDC guideline for prescribing opioids for pain recently became available. Nonopioid drugs for pain were reviewed in a previous issue.

Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid, will soon be marketed in the USA as (Ciba-Geigy), an oral drug for dissolution of gallbladder stones. The labeling for the drug, which has been available in other countries for the past ten years, will restrict its use to dissolution of radiolucent, noncalcified gallbladder stones less than 20 mm in diameter in patients who have refused or are at increased risk from surgery.