The results of a clinical trial (PRECISION) comparing the cardiovascular safety of the COX-2 selective NSAID celecoxib (Celebrex, and generics) with that of ibuprofen and naproxen, which are nonselective, have been described in the lay press in terms that may overestimate the safety of celecoxib.

The FDA has approved an over-the-counter (OTC) 0.025% ophthalmic formulation of the selective alpha₂-adrenergic agonist brimonidine tartrate (Lumify – Bausch & Lomb) for treatment of ocular redness in adults and children ≥5 years old. Lumify is the first brimonidine product to be approved for OTC use.

On June 25, 2021, the FDA added a warning to the Fact Sheets for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) about an increased risk of myocarditis and pericarditis following administration of the vaccines.

View the Table: GLP-1 and GIP/GLP-1 Receptor Agonists for Chronic Weight Management

The FDA has approved two subcutaneously injected calcitonin gene-related peptide (CGRP) antagonists, fremanezumab-vfrm (Ajovy – Teva) and galcanezumab-gnlm (Emgality – Lilly), for migraine prevention in adults. Fremanezumab and galcanezumab are the second and third subcutaneously injected monoclonal antibodies that target the CGRP pathway to be approved by the FDA for this indication; erenumab-aooe (Aimovig), which targets the CGRP receptor, was the first.

Cytomegalovirus immune globulin (CMVIG) for intravenous administration is now available in the USA on an investigational basis (FE Young and SL Nightingale, JAMA, 260:224, July 8, 1988) for prevention of cytomegalovirus (CMV) infection in CMV-seronegative renal transplant recipients who receive a kidney from a seropositive donor. CMVIG contains IgG antibodies from a pool of healthy donors with high titers of antibodies against CMV. The drug can be obtained from the Massachusetts Department of Public Health Biologic Laboratories (617-522-3700, extension 264) or the American Red Cross...

Topotecan hydrochloride (Hycamtin - SmithKline Beecham) was recently approved by the U.S. Food and Drug Administration for parenteral use as a single agent in patients with metastatic ovarian cancer refractory to other drugs. Initial treatment for metastatic ovarian cancer usually consists of cisplatin (Platinol) or carboplatin (Paraplatin) plus paclitaxel (Taxol) or cyclophosphamide (Cytoxan, and others).

Anagrelide (an ag' gre lide) hydrochloride (Agrylin - Roberts), a quinazolin derivative, has been approved by the FDA for oral treatment of essential thrombocythemia. Patients with this uncommon myeloproliferative disorder have an increased number of circulating platelets and are at risk for both thrombosis and hemorrhage.

Ceritinib (Zykadia – Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). It is the second tyrosine kinase inhibitor to be approved for ALK-positive metastatic NSCLC; crizotinib was the first. Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma.

The FDA has approved the use of a transcutaneous electrical nerve stimulation device (Cefaly – Cefaly Technology) for prevention of episodic migraine in patients ≥18 years old. The first device to be approved in the US for migraine prevention, it is available in Canada and Europe for treatment and prevention of migraines. A transcranial magnetic stimulation device (SpringTMS - eNeura Therapeutics) recently approved by the FDA for treatment of migraine preceded by aura will be reviewed in a future issue.