Proton pump inhibitor , safety

Other agents that appear to be safe for use in pregnancy include the proton pump inhibitors, sucralfate, and meto-clopromide (Table 44-5). The proton pump inhibitor with the largest body of human safety data during pregnancy is omeprazole.24... 

Since their introduction in the late 1980s, these efficacious acid inhibitory agents have assumed the major role for the treatment of acid-peptic disorders. Proton pump inhibitors (PPIs) are now among the most widely prescribed drugs worldwide due to their outstanding efficacy and safety. 

Proton pump inhibitors are extremely safe. Diarrhea, headache, and abdominal pain are reported in 1-5% of patients, although the frequency of these events is only slightly increased compared with placebo. Proton pump inhibitors do not have teratogenicity in animal models however, safety during pregnancy has not been established. 

H2-receptor antagonists continue to be prescribed commonly. However, due to their superior acid inhibition and safety profile, proton pump inhibitors (see below) are steadily replacing H2 antagonists for most clinical indications. 

Esomeprazole is the 5-isomer of omeprazole. The pharmacology, pharmacokinetics, efficacy, and safety of esomeprazole have been reviewed (1). Esomeprazole produces acid control comparable to that of currently available proton pump inhibitors. It undergoes less hepatic metabolism than omeprazole, has an oral availability of 89% at a dose of 40 mg, and a half-life of 1.5 hours. Esomeprazole is well tolerated its common adverse effects are diarrhea, headache, nausea, abdominal pain, respiratory infection, and sinusitis. 

Lansoprazole is a proton pump inhibitor. Its safety profile has been reviewed based on premarketing chnical studies, and has to be regarded with the reservations appropriate to this type of material. In 4749 patients the most frequent adverse effects were headache (4.7%), diarrhea (3.2%), abdominal pain (2.2%), pharyngitis (1.8%), and nausea (1.4%) some patients had upper respiratory complaints or suffered anxiety or depression, or myalgia (1). The adverse reaction profile appears to be closely similar to that of omeprazole. 

Israel DM, Hassall E. Omerprazole and other proton pump inhibitors pharmacology, efficacy, and safety, with special reference to use in children. J Pediatr Gastroenterol Nutr 1998 27(5) 568-79. 

Proton pump inhibitors (PPIs) were introduced in 1989 with the development of omeprazole. Since then, they have become one of the most widely prescribed class of drugs on the market today. Over 43 million prescriptions were written for anti-ulcer therapy in the US in 2005 [1]. Currently, there are five PPIs available in the United States and Europe esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole. Their safety and efficacy profile is excellent, which has been the major factor leading to... 

The proton pump inhibitors are usually well tolerated however, potential adverse effects include headache, dizziness, somnolence, diarrhea, constipation, and nausea. The frequency of adverse events appears to be similar to that seen with the H2-receptor antagonists. Concern and controversy regarding the safety of therapy with a proton pump inhibitor are based on the proton pump inhibitor s ability to cause hypergastrinemia and gastric carcinoid tumors in rats. After nearly a decade of experience with the proton pump inhibitors, gastric carcinoid tumors have not been directly linked to omeprazole use in humans. ... 

The selection of an HPeradication regimen should be based on efficacy, safety, antibiotic resistance, cost, and the likelihood of compliance. Treatment should be initiated with a proton pump inhibitor-based three-drug regimen. If a second course of HP therapy is required, the regimen should contain different antibiotics. 

The Hj receptor antagonists were the first truly effective drugs for the therapy of acid-peptic disease, and their long history of safety and efficacy with the eventually led to their avaUabihty without a prescription. Increasingly, proton pump inhibitors (some also available OTC) are replacing the Hj receptor antagonists in cUnical practice. 

Dabholkar AH, Han C, Paris MM, Perez MC, Atkinson SN, Peura DA. The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2011 33 366-77. 

Other Safety Concerns with Proton Pump Inhibitors. 423... 

Orenstein SR, Hassall E, Furmaga-Jablonska W, Atkinson S, Raanan M. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efli-cacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of... 

Freston JW (1997) Long-term acid control and proton pump inhibitors interactions and safety issues in perspective. Am J Gastroenterol 92(Suppl) 51S-57S... 

Arnold R (1994) Safety of proton pump inhibitors - an overview. Aliment Pharmacol Ther 8 65-70... 

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