[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.
Prescription omeprazole is used alone or with other medications 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). Prescription omeprazole is used to treat the symptoms of GERD, allow the esophagus to heal, and prevent further damage to the esophagus. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori). Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week). Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Prescription omeprazole comes as a delayed-release capsule, and packets of delayed-release (long-acting) granules for suspension (to be mixed with liquid) to take by mouth. Nonprescription (over-the-counter) omeprazole comes as a delayed-release capsule or tablet to take by mouth. The delayed-release capsules and the granules should be taken at least 1 hour before a meal. They are usually taken once a day before a meal but may be taken twice a day when used with other medications to eliminate H. pylori, or up to three times a day when used to treat conditions in which the stomach produces too much acid. The nonprescription delayed-release tablets or capsules are usually taken once a day in the morning at least 1 hour before eating for 14 days in a row. Additional 14-day treatments may be repeated once every 4 months if needed. To help you remember to take omeprazole, take it at around the same time(s) every day. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take omeprazole exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor or stated on the package. Tell your doctor if you have taken nonprescription omeprazole for a longer period of time than stated on the package.
If you are taking the delayed-release tablets, swallow them whole with a full glass of water. Do not split, chew, or crush them or crush and mix them into food.
Swallow the delayed-release capsules whole. If you have difficulty swallowing the delayed-release capsules, place one tablespoon of soft, cool applesauce in an empty bowl. Open the delayed-release capsule and carefully empty all the granules inside the capsule onto the applesauce. Mix the granules with the applesauce and swallow the mixture immediately with a glass of cool water. Do not chew or crush the granules. Do not store the applesauce/granule mixture for future use.
If you are taking the powder for oral suspension, you will need to mix it with water before use. If you are using the 2.5-mg packet, place 1 teaspoonful (5 mL) of water in a container. If you are using the 10-mg packet, place 1 tablespoonful (15 mL) of water in a container. Add the contents of the powder packet and stir. Wait 2 to 3 minutes to allow the mixture to thicken, and stir the mixture again. Drink the entire mixture within 30 minutes. If any of the mixture is stuck to the container, pour more water into the container, stir and drink all the mixture immediately.
The powder and the contents of the prescription delayed-release capsules can both be given through a feeding tube. If you have a feeding tube, ask your doctor how you should take the medication. Follow the directions carefully.
Do not take nonprescription omeprazole for immediate relief of heartburn symptoms. It may take 1 to 4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment. Do not take nonprescription omeprazole for longer than 14 days or treat yourself with omeprazole more often than once every 4 months without talking to your doctor.
Continue to take omeprazole even if you feel well. Do not stop taking prescription omeprazole without talking to your doctor. If your condition does not improve or gets worse, call your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
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.
stomach pain
diarrhea
constipation
gas
nausea
vomiting
headache
fever
rash
hives
itching
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
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 omeprazole 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.
Some people who take omeprazole for a long time may develop weakening of the stomach lining.
Talk to your doctor about the risks of taking omeprazole.
Omeprazole 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 light, 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 or pounding heartbeat
nausea
vomiting
sweating
flushing (feeling of warmth)
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. If you are taking prescription omeprazole, 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.