[Posted 02/08/2012] ISSUE: FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.
FDA is also reviewing the risk of CDAD in users of histamine H2-receptor blockers. H2-receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.
BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.
Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in hospitals.
A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Esomeprazole is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach). Esomeprazole is used to treat the symptoms of GERD, allow the esophagus to heal, and prevent further damage to the esophagus. Esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine). It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori). Esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Esomeprazole comes as a delayed-release (long-acting) capsule to take by mouth or to open, mix with water, and give through a feeding tube and as granules to mix with water and take by mouth or give through a feeding tube. Esomeprazole is usually taken once a day at least 1 hour before a meal. When esomeprazole is used to treat certain conditions in which the stomach makes too much acid, it is taken twice a day. Take esomeprazole at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take esomeprazole exactly as directed. Do not take more or less of it or take it more often than or for a longer period of time than prescribed by your doctor or stated on the package.
Swallow the capsules whole; do not split, chew, or crush them. If you cannot swallow the capsule, put 1 tablespoon of cool, soft applesauce in an empty bowl. Open one esomeprazole capsule and carefully sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce, and swallow the entire tablespoonful of the applesauce and pellet mixture immediately. Do not chew the pellets in the applesauce. Do not save the pellets and applesauce for later use.
Place 1 tablespoon (15 mL) of water into a cup.
Open the esomeprazole packet and empty the granules into the cup containing the water.
Stir the granules into the water and leave the mixture alone for 2 to 3 minutes so that it will thicken.
Stir the mixture again, and drink all of the mixture within 30 minutes.
If any material remains in the cup after drinking, add some more water and stir. Drink all of the mixture immediately.
The granules and the contents of the capsules can both be given through a feeding tube. If you have a feeding tube, ask your doctor or pharmacist how you should take the medication. Follow those directions carefully.
It may take several weeks or longer for you to feel the full benefit of esomeprazole. Call your doctor if your symptoms worsen or do not improve during this time. Continue to take esomeprazole even if you feel well. Do not stop taking esomeprazole without talking to your doctor.
If your condition does not improve or gets worse, call your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
headache
diarrhea
nausea
gas
stomach pain
constipation
dry mouth
blisters or peeling skin
hives
rash
itching
difficulty breathing or swallowing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
irregular, fast, or pounding heartbeat
excessive tiredness
dizziness
lightheadedness
muscle spasms
uncontrollable shaking of a part of the body
seizures
People who take proton pump inhibitors such as esomeprazole may be more likely to fracture their wrists, hips, or spine than people who do not take one of these medications. The risk is highest in people who take high doses of one of these medications or take them for one year or longer. The risk may also be higher in people who are 50 years of age or older. Talk to your doctor about the risk of taking esomeprazole.
Esomeprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
confusion
drowsiness
blurred vision
fast heartbeat
nausea
sweating
flushing
headache
dry mouth
Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 02/15/2012
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.