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 the oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) for extended adjuvant treatment of adults with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer, following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in about 20% of breast cancers. Up to 30% of early-stage, HER2-positive breast cancer cases treated with trastuzumab-based adjuvant therapy recur.

Consensi (Coeptis/Burke), a fixed-dose combination of the calcium channel blocker amlodipine (Norvasc, and others) and the COX-2 selective NSAID celecoxib (Celebrex, and generics), has been approved by the FDA for treatment of patients who have hypertension and osteoarthritis.

Akeega (Janssen), a fixed-dose combination of the oral poly(ADP-ribose) polymerase (PARP) inhibitor niraparib (Zejula) and the antiandrogen abiraterone acetate (Zytiga, and others), has been approved by the FDA for use in combination with prednisone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Niraparib has been available since 2017 for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer. Abiraterone acetate has been available since 2011 for treatment of CRPC...

Ashwagandha is an herb extracted from the roots of an evergreen shrub (Withania somnifera) found in India that has been used as a "tonic" for centuries. No specific constituent has been identified as an active ingredient. Herbal supplements containing ashwagandha, which is also known as winter cherry and Indian ginseng, are widely promoted now in the US for treatment of pain, anxiety, stress, fatigue, sleep disturbances, cognitive decline, diabetes, arthritis, male infertility, and various cancers.

The oral poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna – Pfizer) has been approved by the FDA for use in combination with the androgen receptor blocker enzalutamide (Xtandi) for treatment of adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug has been available since 2018 for treatment of deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.

Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article on this subject, some new data have become available.

The FDA has approved Diclegis (Duchesnay), a fixed-dose, delayed-release combination of the H1-antihistamine doxylamine and the vitamin B6 analog pyridoxine, for treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. It is only available by prescription. Doxylamine and pyridoxine, both currently available over the counter, were previously available by prescription in a fixed-dose combination (Bendectin) for morning sickness. Bendectin was voluntarily withdrawn in the US in 1983 because of claims of teratogenicity that have since been...

New guidelines from The National Cholesterol Education Program recommend, as a therapeutic option, lowering treatment goals for LDL cholesterol (LDL-C) from <100 mg/dL to <70 mg/dL for patients at very high risk for coronary heart disease and from 130 mg/dL to <100 mg/dL for those at moderately high risk. A likely consequence of these recommendations is increased use of statins and use of higher doses with a concomitant increase in adverse effects.

The Medical Letter reported last year that sildenafil (Viagra - Pfizer) appeared to be effective for idiopathic pulmonary arterial hypertension (PAH), but confirmation from a controlled trial was needed. Now the results of such a study are about to be published, and the drug has been approved by the FDA for this indication under the trade name Revatio.