About refractory GERD
About refractory GERD
Gastroesophageal reflux disease (GERD) is an uncomfortable condition in which acid from the stomach enters the esophagus, causing discomfort and, over time, damage to the esophagus. Proton pump inhibitors (PPIs) are a common type of medicine that alleviates symptoms in many people with GERD.
Refractory GERD is a condition in which standard acid reflux medications do not or no longer relieve GERD symptoms. It is a serious condition that can be treated effectively, but if left untreated, can lead to a damaged esophagus.
Metozolv ODT* is a prescription medicine used in adults for 4 to 12 weeks to relieve heartburn symptoms of GERD when certain other treatments do not work (refractory GERD). If you have refractory GERD, talk to your healthcare professional to see if Metozolv ODT may be right for you.
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Refractory GERD symptoms
Refractory GERD is GERD that is resistant to standard treatments, so the symptoms and risk factors are the same for both conditions. These symptoms may include
- Heartburn—Burning sensation under the breastbone
- Regurgitation—The return of partly digested food or liquid from the stomach to the mouth or esophagus
- Chest pain—Burning pain in the chest or upper abdomen. This pain may feel somewhat like heart pain
- Cough—Often happens along with heartburn and regurgitation
- Hoarseness—Stomach acid enters into the esophagus and irritates the vocal cords, causing a person’s voice to weaken
- Difficulty swallowing—Regurgitation of stomach acid can cause damage to the esophagus, which can make it hard for some people to swallow food and liquids
- Sleep disturbances—People with refractory GERD may wake up during the night because of discomfort. Symptoms may also get worse when a person is lying down
If you are experiencing any of these symptoms, talk to your healthcare professional. He or she can help determine if you have refractory GERD and prescribe the right medicine for you.
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Refractory GERD risk factors
Refractory GERD and GERD may be influenced by several lifestyle and dietary factors, but you should speak with your healthcare professional before making any lifestyle or diet changes. Some causes may include
- Obesity—Being overweight or obese appears to be one of the leading GERD risk factors. There may be a relationship between an increase in a person’s body mass index (BMI) and GERD symptoms4
- Dietary habits—Consuming certain kinds of food and drink is a potential GERD risk factor. Some of these foods and drinks include alcohol, carbonated drinks, fatty foods, spicy foods, chocolate, citrus fruits and juices, and mint4
- Smoking—Surveys have shown that smokers have higher rates of reflux symptoms than nonsmokers4
If efforts to prevent refractory GERD are unsuccessful, ask your healthcare professional about Metozolv ODT, a treatment option for refractory GERD.
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Important Safety Information About METOZOLV® ODT
WARNING: TARDIVE DYSKINESIA
See full prescribing information for complete boxed warning.
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
Call your doctor right away if you experience symptoms you cannot stop or control such as lip smacking, chewing, or puckering of your lips; frowning or scowling; sticking out of your tongue; blinking and moving your eyes; or shaking of your arms and legs.
It is not possible for your doctor to know if you will get TD if you take METOZOLV ODT. Factors that increase your risk for TD include increased age, especially for females; a diagnosis of diabetes; and extended use and increased dosage of METOZOLV ODT. You should not take METOZOLV ODT for more than 12 weeks.
METOZOLV ODT can cause other serious side effects including uncontrolled muscle spasms; depression, thoughts about suicide, and suicide; a rare but potentially fatal disorder known as neuroleptic malignant syndrome (NMS), the symptoms of which include high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased swelling; parkinsonism, the symptoms of which include slight body shaking, body stiffness, and trouble moving or keeping your balance; high blood pressure; and too much body water. If you experience any of these symptoms, call your doctor and get medical help right away.
The most common side effects of METOZOLV ODT include headache, nausea, vomiting, tiredness, and sleepiness. Tell your doctor about any side effects that bother you or do not go away.
You may still have side effects after stopping METOZOLV ODT, and you may have symptoms from stopping METOZOLV ODT (withdrawal symptoms), such as headaches and feeling dizzy or nervous.
Do not drink alcohol while taking METOZOLV ODT, as it may worsen some side effects. Do not drive, work with machines, or do dangerous tasks until you know how METOZOLV ODT affects you.
Do not take METOZOLV ODT if you have stomach or intestinal problems, such as bleeding, blockage, or a tear in your stomach or bowel wall; have an adrenal tumor (pheochromocytoma); are allergic to metoclopramide or any of the ingredients in METOZOLV ODT; take medications that can cause uncontrolled movements, such as medicines for mental illness; or have seizures.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Patient Medication Guide and full Prescribing Information for METOZOLV ODT, including BOXED WARNING.
References: 1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed May 6, 2009.
3. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=METOCLOPRAMIDE%20HYDROCHLORIDE. Accessed May 6, 2009.
4. Kaltenbach T, Crockett S, Gerson LB. Are lifestyle measures effective in patients with gastroesophageal reflux disease? An evidence-based approach. Arch Intern Med. 2006;166:965-971.