The FDA has approved the pyrimidine analog uridine triacetate (Xuriden [zur' uh den] – Wellstat Therapeutics) for treatment of hereditary orotic aciduria, a rare autosomal recessive disorder (estimated birth prevalence: <1:1,000,000) in infants and children caused by a deficiency in uridine 5'-monophosphate (UMP) synthase. This deficiency prevents synthesis of uridine nucleotides and causes developmental delays, failure to gain weight, hematologic abnormalities, and excessive urinary excretion of orotic acid, which can lead to urinary obstruction.1 Xuriden is the first drug to be approved...

In our recent article on Lipid-Lowering Drugs,1 we said that statins can reduce the risk of first cardiovascular events and death (primary prevention) in patients at high risk for atherosclerotic cardiovascular disease (CVD) and significantly reduce the incidence of cardiovascular events in patients at lower risk for CVD. Now the United States Preventive Services Task Force (USPSTF) has issued new recommendations on the appropriate use of statins for primary prevention of CVD.2The USPSTF states that clinicians should periodically screen all persons 40-75 years old for cardiovascular risk...

The FDA has approved a 1.5% topical cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) for short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients ≥12 years old whose disease has not been adequately controlled with other topical prescription drugs. Ruxolitinib is the first JAK inhibitor to be approved for topical use and the first to be approved in the US for treatment of AD. An oral formulation of ruxolitinib (Jakafi) is approved for treatment of myelofibrosis, polycythemia...

The FDA has required changes in the labels of all testosterone products to reflect new data on their cardiovascular effects. The updated labels will no longer include a boxed warning about an increased risk of adverse cardiovascular outcomes, but will contain a new warning about an increase in blood pressure.

The FDA has approved a new titration regimen for donanemab (Kisunla – Lilly), an IV amyloid beta-directed monoclonal antibody indicated for treatment of Alzheimer's disease. The new regimen is intended to reduce the risk of serious amyloid-related imaging abnormalities (ARIA) associated with use of the drug.

About 60% of men ≥60 years old have clinically relevant prostatic enlargement due to benign prostatic hyperplasia (BPH). The goals of treatment are to decrease lower urinary tract symptoms and to prevent disease progression and complications such as acute urinary retention. The American Urologic Association's guidelines for treatment of BPH were recently updated.

Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other antiretrovirals to treat HIV infection in highly treatment-experienced adults who have ongoing viral replication or in those with HIV strains known to be resistant to multiple protease inhibitors.

The FDA has recently approved RotaTeq (Merck), an oral live, human-bovine reassortant rotavirus vaccine, for use in infants to prevent rotavirus gastroenteritis, a frequent cause of severe diarrhea in infancy.

The FDA has approved prasugrel (Effient - Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI). It will compete with clopidogrel (Plavix) for such use.

The FDA has approved upadacitinib (Rinvoq – Abbvie), 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 cannot tolerate methotrexate (Trexall, and others). Upadacitinib is the third JAK inhibitor to be approved in the US for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) and baricitinib (Olumiant) were approved earlier.