The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Interstitial Nephritis
- Clostridium difficile-Associated Diarrhea
- Bone Fracture
- Cutaneous and Systemic Lupus Erythematosus
- Fundic Gland Polyps
Clinical Trials Experience With Intravenous NEXIUM
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of intravenous esomeprazole is based on results from clinical trials conducted in four different populations including patients having symptomatic GERD with or without a history of erosive esophagitis (n=199), patients with erosive esophagitis (n=160), healthy subjects (n=204) and patients with bleeding gastric or duodenal ulcers (n=375).
Symptomatic GERD And Erosive Esophagitis Trials
The data described below reflect exposure to NEXIUM I.V. for Injection in 359 patients. NEXIUM I.V. for Injection was studied only in actively-controlled trials. The population was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, 28% Other, and had either erosive reflux esophagitis (44%) or GERD (56%). Most patients received doses of either 20 or 40 mg either as an infusion or an injection. Adverse reactions occurring in ≥1% of patients treated with intravenous esomeprazole (n=359) in clinical trials are listed below:
Table 2: Adverse Reactions Occurring at an Incidence ≥ 1% in the NEXIUM I.V. Group
|Adverse Reactions||% of patients Esomeprazole Intravenous
|Injection site reaction||1.7|
Intravenous treatment with esomeprazole 20 and 40 mg-administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of esomeprazole.
A randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily esomeprazole in pediatric patients 1 month to 17 years old, inclusive was performed. The safety results are consistent with the known safety profile of esomeprazole and no unexpected safety signals were identified .
Risk Reduction Of Rebleeding Of Gastric Or Duodenal Ulcers In Adults
The data described below reflect exposure to NEXIUM I.V. for Injection in 375 patients. NEXIUM I.V. for Injection was studied in a placebo-controlled trial. Patients were randomized to receive NEXIUM I.V. for Injection (n=375) or placebo (n=389). The population was 18 to 98 years old; 68% Male, 87% Caucasian, 1% Black, 7% Asian, 4% other, who presented with endoscopically confirmed gastric or duodenal ulcer bleeding. Following endoscopic hemostasis, patients received either 80 mg esomeprazole as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for a total treatment duration of 72 hours. After the initial 72-hour period, all patients received oral proton pump inhibitor (PPI) for 27 days.
Table 3: Incidence (%) of Adverse Reactions that Occurred in Greater than 1 % of Patients within 72 Hours after Start of Treatment1
With the exception of injection site reactions described above, intravenous treatment with esomeprazole administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of esomeprazole.
The following adverse reactions have been identified during post-approval use of NEXIUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing Reports – There have been spontaneous reports of adverse events with postmarketing use of esomeprazole. These reports occurred rarely and are listed below by body system:
Blood And Lymphatic System Disorders: agranulocytosis, pancytopenia; Eye Disorders: blurred vision; Gastrointestinal Disorders: pancreatitis; stomatitis; microscopic colitis; fundic gland polyps; Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice; Immune System Disorders: anaphylactic reaction/shock; systemic lupus erythematosus; Infections and Infestations: GI candidiasis; Metabolism and nutritional disorders: hypomagnesemia with or without hypocalcemia and/or hypokalemia; Musculoskeletal And Connective Tissue Disorders: muscular weakness, myalgia, bone fracture; Nervous System Disorders: hepatic encephalopathy, taste disturbance; Psychiatric Disorders: aggression, agitation, depression, hallucination; Renal and Urinary Disorders: interstitial nephritis; Reproductive System and Breast Disorders: gynecomastia; Respiratory, Thoracic and Mediastinal Disorders: bronchospasm; Skin and Subcutaneous Tissue Disorders: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal), cutaneous lupus erythematosus.
Other adverse events not observed with NEXIUM, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.
Read the entire FDA prescribing information for Nexium (Esomeprazole Magnesium)
Nexium® 24HR is a non-prescription medication for the treatment of frequent heartburn (occurs 2 or more days a week). It is not intended for immediate relief of heartburn and may take 1 to 4 days for full effect.
HOW TO TAKE NEXIUM® 24HR. Like most medications, Nexium® 24HR works best when you use it properly. Make sure to follow these helpful tips:
- Set a schedule: Nexium® 24HR should be taken once a day in the morning (every 24 hours) for two weeks, so set a reminder to take your daily dose before breakfast.
- Stay the course: Even if you start feeling better within the first few days, stick with the 14-day treatment to get maximum results
- Plan ahead: Nexium® 24HR isn’t intended for immediate relief, so be proactive with your next purchase to stop acid before it starts.
Directions: Adults (>18 years): Do not take more than directed. Swallow 1 capsule with a glass of water before eating in the morning. Take 1 capsule per day for 14 days. May take 1 to 4 days for full effect. Do not take for more than 14 days or more often than every 4 months unless directed by your doctor. See package insert for repeat use directions.
Are you currently using Nexium?
Read the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking esomeprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily, at least 1 hour before a meal. If you are self-treating, follow all directions on the product package. The dosage and length of treatment are based on your medical condition and response to treatment. Do not increase your dose or take this drug more often than directed. If you have any questions, ask your doctor or pharmacist.
Do not crush or chew this medication. Swallow the capsules whole. If you have difficulty swallowing this medication whole, you may open the capsule and sprinkle the contents into a tablespoon of unheated applesauce. Swallow the applesauce mixture right away without chewing it. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug.
If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take esomeprazole at least 30 minutes before sucralfate.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better. If you are self-treating with the over-the-counter product, do not take it for more than 14 days unless directed by your doctor.
Tell your doctor if your condition persists or worsens. If you are self-treating, tell your doctor if your heartburn persists after 14 days or if you need to use this medication more than once every 4 months. The risk of side effects goes up over time. Ask your doctor how long you should take this medication. If you think you may have a serious medical problem, get medical help right away.
FRIDAY, Jan. 18, 2002 (HealthDayNews) — A new study suggests that gastritis would be better treated with antibiotics than potent acid-reducing drugs, which the researchers say can do more harm than good in certain cases.
The study’s conclusion wanders astray from the common treatment for the condition — reducing acid — and left another expert with the intellectual equivalent of an upset stomach.
“When you completely block acid production, you encourage the growth of bacteria, which in turn increases stomach inflammation and sets the stage for chronic gastritis,” says study author Dr. Juanita Merchant, associate professor of internal medicine and physiology at the University of Michigan Health System.
Antibiotics, says Merchant, “address the problem at the source — the bacteria.”
Gastritis is an inflammation of the stomach lining.
Merchant says over-the-counter antacids like Tagamet, Pepcid AC, and Zantac aren’t as harmful because they allow some acid production to continue. But she does take issue with powerful prescription antacids known as proton pump inhibitors — medications such as Prilosec (omeprazole), Prevacid (lansoprazole), Protonix (pantoprazole), or Aciphex (rabeprazole), which work by shutting down all acid production.
“These drugs won’t help gastritis, and they could make problems worse by creating an environment that encourages bacteria to grow,” she says.
Other doctors are not so quick to dismiss conventional wisdom.
Dr. Ali Karakurum, a gastroenterologist and assistant professor of medicine at Nassau University Medical Center in New York, finds the results “highly questionable.”
Eliminating bacteria, he says, has proven helpful only in those patients with ulcer disease caused by the bacterium Helicobacter pylori. “There are no studies showing any other type of bacteria is linked to gastritis, so I have to question the basic premise of the study,” adds Karakurum.
Merchant’s theory of bacteria-mediated gastritis revolves around a substance called gastrin, a chemical secreted by the stomach lining in response to inflammation — including the presence of bacteria. Gastrin, she says, triggers the production of excess stomach acid.
While the excess acid itself is often blamed for stomach woes, Merchant says her animal study shows it may be there for a reason. She claims that the bacteria that set gastrin into action — not the excess acid — are the real cause of the stomach problems.
More important, she believes that without treatment targeted to reduce bacteria, we could be setting ourselves up for far more severe stomach problems, including cancer.
“If you don’t treat the bacteria, you won’t get rid of the problem — at least that’s what our studies showed,” says Merchant.
Karakurum disagrees. “Most cases of gastritis are self-limiting,” he says. “They disappear on their own whether or not you find or treat any bacteria,” he says.
Merchant’s study compared the stomach linings of normal mice with those genetically altered not to produce gastrin and were thus unable to make stomach acid.
At the start of the study, researchers washed the stomach linings of all the mice, and tested the fluid for the presence of bacteria. Eliminating those mice not shown to have the ulcer-causing H. pylori bacteria — which aren’t affected by acid — they selected those that tested positive for three other types of bacteria: Lactobacillus, Enterobacter, and Staphylococcus.
The group of infected mice deficient in gastrin were treated with antibiotics for 20 days. The infected mice with normal levels of gastrin were treated for 60 days with the proton pump inhibitor omeprazole.
At the end of the study, researchers once again examined the stomach linings of the mice.
The mice given the antibiotic showed a marked reduction in inflammation and bacteria, the study found. The mice taking the acid-blocking omeprazole were shown to have increased inflammation and more bacteria than when the study started.
Further, subsequent treatment of the second group with antibiotics resulted in a similar reduction in inflammation seen in the first group — even though the mice continued on the omeprazole.
Karakurum finds an important flaw within the study design.
“H. pylori bacteria is not found in the stomach lining. It requires a biopsy of the tissue, where it hides,” he says. Not finding H. pylori in the lining is not verification that it wasn’t present, says Karakurum. And if it was, he says, then that would account for the improvement in the mice that took the antibiotic. It would also explain why the antacids didn’t work.
The study was published simultaneously in the January issues of the journals Gastroenterology and the American Journal of Physiology.
What To Do
For an overview of common stomach problems and effective treatments, visit the American College of Gastroenterology.
For specific information on dealing with gastritis, visit The Merck Manual.
To learn more about how proton pump inhibitors work, click here.