The FDA has approved tesamorelin (Egrifta – EMD Serono), an injectable synthetic analog of growth-hormone- releasing factor (GRF), for reduction of excess abdominal fat in patients with lipodystrophy associated with HIV infection. Growth hormone (somatropin – Serostim; EMD Serono) has been available for years for treatment of HIV wasting.

The FDA has approved ibrutinib (eye broo' ti nib; Imbruvica – Janssen/Pharmacyclics), an oral kinase inhibitor, for second-line treatment of chronic lymphocytic leukemia (CLL). It is the first kinase inhibitor to be approved for CLL. Ibrutinib was approved earlier for second-line treatment of mantle cell lymphoma, a rare form of B-cell non-Hodgkins lymphoma.

The FDA has approved the combined use of the programmed death receptor-1 (PD-1) blocking antibody nivolumab (Opdivo) and the anti-CLA-4 antibody ipilimumab (Yervoy) for treatment of BRAF V600 wild-type unresectable or metastatic melanoma. This is the first immunotherapy combination to be approved for treatment of any type of cancer.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga), which was initially approved by the FDA for treatment of type 2 diabetes and then to reduce the risk of hospitalization for HF in adults who have type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular risk factors, has now been approved for a third indication: to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in patients with heart failure with reduced ejection fraction (with or without type 2 diabetes). It is the first SGLT2 inhibitor to...

The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray formulations, Narcan and one of its generics, were approved for OTC sale in 2023.

We reviewed brolucizumab (Beovu – Novartis) for treatment of neovascular (wet) age-related macular degeneration in our February 10 issue. On February 23, the American Society of Retina Specialists reported that 14 patients who received the drug have developed retinal vasculitis, a potentially vision-threatening complication.

Diclofenac sodium (Voltaren - Geigy), a nonsteroidal anti-inflammatory drug (NSAID) available in some countries since 1974, was recently introduced in the USA for treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. It is being promoted as 'The number one prescribed antiarthritic in the world.'

Ziprasidone (Geodon - Pfizer), a benzisothiazolyl piperazine, has been approved by the FDA for oral treatment of schizophrenia. An intramuscular formulation will probably be available in the near future.

Tegaserod maleate (teg a ser' od; Zelnorm - Novartis), a serotonin derivative, has received FDA approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Alosetron (Lotronex), which was withdrawn previously because of toxicity, will soon be available again for women with severe diarrhea-predominant IBS (Medical Letter 2002; 44:67).

When the nicotine receptor partial agonist varenicline (Chantix – Pfizer) was first marketed, The Medical Letter concluded that it was moderately effective in increasing smoking cessation rates.1 More recent publications and the clinical experience of Medical Letter consultants now suggest that varenicline is the most effective drug available for this indication, more effective than nicotine replacement therapy or bupropion SR (Zyban).2,3 A word of caution: exacerbations of psychiatric illness have been reported in patients who took higher-than-recommended starting doses of varenicline.4,5...