The FDA has approved adjunctive treatment with Dartisla ODT (Edenbridge), a new orally disintegrating tablet (ODT) formulation of the anticholinergic drug glycopyrrolate, to reduce symptoms of a peptic ulcer. Glycopyrrolate oral tablets (Robinul, Robinul Forte, and generics) were approved for the same indication in 1961.

An IV formulation of pantoprazole sodium (Protonix IV - Wyeth-Ayerst), a benzimidazole proton pump inhibitor (PPI), has been approved by the FDA for short-term treatment of Zollinger-Ellison Syndrome (ZES) and gastroesophageal reflux disease (GERD) in patients who cannot take oral drugs. Pantoprazole is the first PPI to be approved for IV use in the US.

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 Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are common causes of peptic ulcer disease. Patients infected with Helicobacter pylori who take aspirin or another NSAID have an especially high risk. Drugs that have been tried for prevention of ulcers in patients taking NSAIDs including H2-receptor antagonists, proton pump inhibitors (PPIs), aluminum- or magnesium-containing antacids, the prostaglandin misoprostol (Cytotec, and others), and antibiotics to eradicate H. pylori.Click here to view the free full...

The FDA has approved marketing of Zegerid powder for oral suspension (Santarus), an immediate-release formulation of the proton-pump inhibitor (PPI) omeprazole (Prilosec, and others). All other oral PPIs are delayed-release, enteric-coated formulations designed to prevent degradation of the drug by gastric acid. Each 20- or 40-mg packet of Zegerid contains 1680 mg of sodium bicarbonate, which protects the drug from gastric acid degradation. A dose of Zegerid contains 460 mg of sodium, which may be excessive for some patients. Zegerid is the first oral PPI to be approved by the FDA for...

The FDA has approved prasugrel (Effient - Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI). It will compete with clopidogrel (Plavix) for such use.

The FDA has approved Yosprala (Aralez), a fixed-dose combination of delayed-release aspirin and immediate-release omeprazole, for secondary prevention of cardiovascular and cerebrovascular events in patients who are at risk of developing aspirin-associated gastric ulcers (≥55 years old or history of gastric ulcers). Yosprala is the first product to become available in the US that combines aspirin and a proton pump inhibitor (PPI).

The FDA has approved the marketing of Vimovo (AstraZeneca), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) naproxen and the proton pump inhibitor (PPI) esomeprazole, for symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk for NSAID-associated ulcers.

Esomeprazole magnesium (Nexium - AstraZeneca), the S-isomer of omeprazole (Prilosec), is the fifth benzimidazole proton pump inhibitor to become available in the United States. Omeprazole, which was the first, is going off patent this year.