Shock-wave generators like those now widely used to disintegrate urinary tract stones (Medical Letter, 27:72, 1985) have recently also been tried for treatment of radiolucent gallbladder stones. Three different types of lithotripsy devices, manufactured by at least eight different companies, are being used to treat gallbladder stones in multicenter trials in many locations in the USA. None of these devices has been approved for marketing by the US Food and Drug Administration.

Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.

The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.

In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical...

The tables in this article list drugs used for treatment of cancer in the USA and Canada and their major adverse effects. The choice of drugs in Table I is based on the opinions of Medical Letter consultants. Some drugs are listed for indications for which they have not been approved by the US Food and Drug Administration. In some cases, such as elderly patients or those with many co-morbid illnesses, the regimen of choice might not be suitable. For many of the cancers listed, surgery and/or radiation therapy may be the treatment of choice or may also be part of the management. Anticancer...

The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader (SERD) fulvestrant (Faslodex, and generics) for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults with one or more PIK3CA/AKT1/PTEN-alterations who had disease progression on at least one endocrine-based regimen for metastatic disease or recurrence on or within 12 months of completing...

Levocetirizine (Xyzal - UCB/Sanofi-aventis), the active enantiomer of the second-generation H₁-antihistamine cetirizine (Zyrtec), has been approved by the FDA for treatment of seasonal and perennial allergic rhinitis (SAR and PAR) and chronic idiopathic urticaria in adults and children 6 years of age and older. Cetirizine has been approved by the FDA for over-the-counter use and may also become available generically in the US. Levocetirizine has been available in Europe since 2001.

The FDA has approved the selective alpha_1A-adrenergic receptor agonist oxymetazoline as a 1% cream (Rhofade – Allergan) for topical treatment of persistent facial erythema of rosacea in adults. Brimonidine, a selective alpha₂-adrenergic receptor agonist, was approved in 2013 as a 0.33% gel (Mirvaso) for the same indication. Like Mirvaso, Rhofade is not indicated for treatment of inflammatory lesions of rosacea. Oxymetazoline has been available over the counter for many years as a nasal decongestant spray (Afrin, and others).

The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.

Vyalev (Abbvie), a solution for continuous subcutaneous infusion containing the prodrugs foscarbidopa and foslevodopa, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Vyalev is the first subcutaneously administered product to become available in the US for treatment of PD symptoms. Duopa, a carbidopa/levodopa enteral suspension infused via a nasojejunal tube or percutaneous gastrostomy, was approved in for the same indication 2015.