In the absence of randomized studies demonstrating an impact on mortality, the US Preventive Services Task Force (USPSTF) has found the evidence insufficient to recommend a routine whole-body examination for melanoma and other skin cancers.

Some readers have objected to our recommendation (Med Lett Drugs Ther 2013; 55:55) that postmenopausal women with an intact uterus who take the oral estrogen agonist/antagonist ospemifene (Osphena) to reduce the severity of dyspareunia should also take a progestin.1 Ospemifene has agonistic effects on the endometrium, and the Osphena package insert says: "Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer."Endometrial hyperplasia has been...

The results of the Age-Related Eye Disease Study 2 (AREDS2) have now been published. The primary purpose of the study was to evaluate the efficacy and safety of the carotenoids lutein and zeaxanthin and the omega-3 polyunsaturated fatty acids (PUFAs) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in reducing the risk of developing advanced age-related macular degeneration (AMD). A secondary goal was to test the effects of reducing the amount of zinc and eliminating beta carotene from the original AREDS formulation. Beta carotene has been shown to increase the risk of...

A reader asked whether healthcare providers should avoid prescribing the angiotensin receptor blocker (ARB) olmesartan medoxomil (Benicar, and others) because it can cause severe GI adverse effects.In 2013, the FDA warned that olmesartan can cause sprue-like enteropathy, a condition characterized by intestinal villous atrophy, severe chronic diarrhea, and significant unintended weight loss. The warning was based on 23 cases of serious sprue-like enteropathy associated with use of olmesartan, some occurring years after starting the drug. All patients improved after stopping olmesartan; 10 had a...

The FDA has approved a nasal spray formulation of fentanyl (Lazanda – Archimedes) for management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and oral transmucosal use.

The FDA has granted regular approval to the oral kinase inhibitor tepotinib (Tepmetko – EMD Serono) for treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases and are associated with advanced disease and a poor prognosis. Tepotinib received accelerated approval for the same indication in 2021 based on initial overall response rates and duration of response.

Teniposide (ten i poe' side; VM 26; Vumon - Bristol), an anticancer drug that has been under investigation in the USA for 20 years, has now been approved for use in combination induction treatment of refractory acute lymphoblastic leukemia (ALL) in children. A semisynthetic derivative of podophyllotoxin, teniposide is chemically related to etoposide (VePesid - Medical Letter, 26:48, 1984).

The FDA has approved a recombinant human papillomavirus (HPV) vaccine (Cervarix – GlaxoSmithKline) for use in girls and women 10-25 years old to prevent infection with HPV types 16 and 18, which have been associated with cervical cancer. A recombinant quadrivalent HPV vaccine (Gardasil – Merck) already on the market in the US prevents infection with HPV types 6, 11, 16 and 18.

The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.

The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...