AUDIENCE: Gastroenterology, Patient
ISSUE: FDA is warning that eluxadoline (Viberzi), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, FDA is working with the eluxadoline manufacturer, Allergan, to address these safety concerns.
See the FDA Drug Safety Communication, available at: http://bit.ly/2muwvqa, for a Data Summary.
BACKGROUND: Eluxadoline is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. Eluxadoline works by decreasing bowel contractions, which leads to less diarrhea. In patients with IBS-D, eluxadoline can help ease stomach-area or abdomen pain and improve stool consistency.
RECOMMENDATION: Health care professionals should not prescribe eluxadoline in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with eluxadoline use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of eluxadoline at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.
Patients should talk to your health care professional about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder. Stop taking eluxadoline right away and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis, an inflammation of the pancreas an organ important in digestion; or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Eluxadoline is used to treat irritable bowel syndrome with diarrhea (IBS-D; a condition that causes stomach pain, cramping, or loose or watery stools) in adults. Eluxadoline is in a class of medications called mu-opioid receptor agonists. It works by decreasing bowel activity.
How should this medicine be used?
Eluxadoline comes as a tablet to take by mouth. It is usually taken with food twice daily. Take eluxadoline at around the same times 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 eluxadoline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Eluxadoline may be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking eluxadoline,
- tell your doctor and pharmacist if you are allergic to eluxadoline, any other medications, or any of the ingredients in eluxadoline tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alfentanil (Alfenta); alosetron (Lotronex); antibiotics such as ciprofloxacin (Cipro) and clarithromycin (Biaxin, in Prevpac); anticholinergic medications such as benztropine (Cogentin), dicyclomine (Bentyl), diphenhydramine (Benadryl); bupropion (Forfivo XL, Wellbutrin, Zyban, others); eltrombopag (Promacta); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine tartrate (Ergomar, in Cafergot, in Migergot); fentanyl (Abstral, Actiq, Duragesic, Sublimaze, others); fluconazole (Diflucan); gemfibrozil (Lopid); medications for HIV such as atazanavir (Reyataz, in Evotaz), lopinavir (Kaletra), and ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), tipranavir (Aptivus); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus XR, Prograf); opiate (narcotic) medications for pain; paroxetine (Brisdelle, Paxil, Pexeva); pimozide (Orap); quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); and rosuvastatin (Crestor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- you should know that you may take loperamide (Imodium AD) occasionally to treat severe diarrhea while taking eluxadoline. Stop taking loperamide immediately if you become constipated.
- tell your doctor if you have constipation now or if you often have constipation or if you drink or have ever drunk large amounts of alcohol (more than 3 alcoholic beverages a day). Also tell your doctor if you have or have ever had bile duct obstruction (blockage in the tubes that carry bile from the liver to the gallbladder and small intestine), sphincter of Oddi dysfunction (blockage of bile or digestive juices flowing into the intestine that causes pain or jaundice), blockage in your intestines, pancreatitis (swelling of the pancreas that does not go away), or liver disease. Your doctor will probably tell you not to take eluxadoline.
- tell your doctor if you do not have a gallbladder.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking eluxadoline, call your doctor.
- you should know that eluxadoline may make you drowsy, especially if you have liver disease. Do not drive a car or operate machinery until you know how this medication affects you.
- tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time. Ask your doctor about the safe use of alcoholic beverages while you are taking eluxadoline. Drinking alcohol may increase the risk that you will develop pancreatitis.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it with food. 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.
What side effects can this medication cause?
Eluxadoline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, stop taking eluxadoline and call your doctor immediately:
- pain that begins in the upper stomach area but may spread to the back or shoulder with or without nausea and vomiting
- constipation lasting more than 4 days
Eluxadoline 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
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).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
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.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Eluxadoline is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
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.