Studies indicate that people who take proton pump inhibitor medications (such as Nexium) may be at an increased risk for broken bones. The risk appears to be highest for people who take such medications at high doses or for long periods (over a year). You and your healthcare provider should take this into account when deciding if the benefits of this medication outweigh the risks for your particular situation.

The use of proton pump inhibitors (including this medication) may increase the risk of a potentially serious condition known as Clostridium difficile-associated diarrhea (CDAD). If you develop diarrhea that does not seem to improve (especially if it is watery and accompanied by a fever and abdominal pain), seek immediate medical attention.

The prominent consumer watchdog group Public Citizen has filed a petition with the FDA, indicating that a new black box warning for Nexium, Prilosec and other proton pump inhibitor drugs is necessary to warn consumers and the medical community about the risk of long-term dependence and other dangerous side effects.

According to the petition (PDF) filed with the FDA on Tuesday, Public Citizen indicates that the strongest possible warning label is necessary for the widely used acid reflux drugs, which were prescribed more than 119 million times in 2009 and generated sales in the United States of $13.6 billion.

An estimated one out of every 20 people in the developed world are currently taking a proton pump inhibitor (PPI) to reduce the production of stomach acid in an attempt to alleviate symptoms of gastroesophageal reflux disease (GERD), ulcers and other stomach ailments. In addition to Nexium and Prilosec, other drugs in the same class included Prevacid, Zegerid, Protonix, Dexilant, Aciphex, Vimovo and a number of generic equivalents.

This medication is used to treat ulcers in the intestines. Sucralfate forms a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly.
How to use sucralfate

Shake the bottle well before each dose. Take this medicine by mouth, usually 2 teaspoonfuls 4 times daily, on an empty stomach at least 1 hour before a meal, or as directed by your doctor.

The dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. It is important to continue taking this medication even if you do not feel ulcer pain. Do not stop taking this medication without consulting your doctor. It may take 4 to 8 weeks for your ulcer to heal completely.

Some medications may not work as well if you take them at the same time as sucralfate. They may need to be taken at a different time of the day than the time you take sucralfate. Ask your doctor or pharmacist for help making a dosing schedule that will work with all your medications.

Antacids can be used with this medicine, but they should be taken at least 30 minutes before or after sucralfate.

Inform your doctor if your condition persists or worsens after you have been taking sucralfate for 4 weeks.

Constipation, dry mouth, upset stomach, gas, and nausea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if these unlikely but serious side effects occur: an unusual/persistent feeling of fullness in the stomach, nausea/vomiting/stomach pain especially after meals.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada.

Before taking sucralfate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, stomach/intestine problems (e.g., delayed gastric emptying), tube feeding.

Kidney function declines as you grow older. This medication contains aluminum, which is normally removed by your kidneys. Therefore, elderly people may be at greater risk for developing high aluminum levels while using this drug with other products that contain aluminum (e.g., antacids).

If you are pregnant, tell your doctor before using sucralfate.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antacids that contain aluminum, certain antibiotics (e.g., quinolones such as ciprofloxacin/levofloxacin/ofloxacin, tetracyclines), cimetidine, digoxin, ketoconazole, penicillamine, phenytoin, quinidine, ranitidine, theophylline, thyroid medications (e.g., levothyroxine, liothyronine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Your doctor may recommend some lifestyle changes such as stress-reducing programs, diet changes and exercise to assist in treatment and prevention of ulcers. This medicine should not be injected into your veins. Do not share this medication with others.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.