The US Food and Drug Administration (FDA) recently approved the marketing of clarithromycin (Biaxin - Abbott), a macrolide antibiotic, and omeprazole (Prilosec - Astra Merck), a proton pump inhibitor, for concurrent use in treatment of duodenal ulcers associated with Helicobacter pylori.

View Table 3: Some Drug Interactions with DAAs for HCV Infection

The FDA has approved a fixed-dose combination of omeprazole, amoxicillin, and rifabutin (Talicia – RedHill) for treatment of Helicobacter pylori infection in adults. Talicia is the first rifabutin-based product to be approved for this indication.

Eohilia (Takeda), an oral suspension formulation of the corticosteroid budesonide, has been approved by the FDA for treatment of eosinophilic esophagitis (EoE) in patients ≥11 years old. It is the first oral drug to be approved in the US for this indication. The subcutaneously injected interleukin (IL)-4 receptor antagonist dupilumab (Dupixent) is approved for treatment of EoE in patients ≥1 year old who weigh ≥15 kg.

The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US. Sofosbuvir (Sovaldi) was approved earlier for use in combination with other antiviral drugs for treatment of HCV infection. Ledipasvir is a new drug.

The FDA has approved teduglutide (te due’ gloo tide; Gattex – NPS), a recombinant DNA analog of glucagon-like peptide-2 (GLP-2), for treatment of short bowel syndrome (SBS) in adults who are dependent on parenteral support.

The FDA has warned that use of the macrolide antibiotic clarithromycin (Biaxin, and generics) may increase the risk of cardiovascular morbidity and mortality in patients with heart disease.

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 new extended-release formulation of the corticosteroid budesonide (Uceris – Santarus) for induction of remission in patients with mild to moderate ulcerative colitis.

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...