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
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.
METOZOLV® ODT (metoclopramide HCl) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed 12 weeks in duration. Take on an empty stomach up to four times daily, at least 30 minutes before eating and at bedtime.
METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal reactions.
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses.
Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after beginning treatment, but also after longer periods. Patients with a history of Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients can experience exacerbation of Parkinsonian symptoms when taking metoclopramide.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability. The management of NMS should include immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy.
Depression associated with metoclopramide use has occurred in patients with and without a history of depression. For those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh the potential risks.
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised when metoclopramide is used in patients with hypertension. Any rapid rise in blood pressure associated with METOZOLV ODT use should result in immediate cessation of metoclopramide use in those patients.
Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. If these side effects occur at any time in any patients during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.
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.