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For Nighttime Heartburn Treatments: Try These First Before you use Metoclopramide There are nondrug treatments, with no safety concerns, and less expensive drugs that may be effective for you; these should be tried before you use any drugs for heartburn. First, try to avoid foods that trigger your condition (e.g., fatty foods, onions, caffeine, peppermint, and chocolate), and avoid alcohol, smoking, and tight clothing.1 Second, avoid food, and particularly alcohol, within two or three... |
For Nighttime Heartburn Treatments: Try These First Before you use Metoclopramide There are nondrug treatments, with no safety concerns, and less expensive drugs that may be effective for you; these should be tried before you use any drugs for heartburn. First, try to avoid foods that trigger your condition (e.g., fatty foods, onions, caffeine, peppermint, and chocolate), and avoid alcohol, smoking, and tight clothing.1 Second, avoid food, and particularly alcohol, within two or three hours of bedtime. Third, elevate the head of the bed about six inches or sleep with extra pillows. For both heartburn and ulcers, it is important to avoid drug-induced causes. Aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs (NSAIDs) are known to cause ulcers. Ask your doctor if acetaminophen could be substituted for these drugs. Check with your doctor about the osteoporosis medications alendronate (FOSAMAX) and risedronate (ACTONEL), which irritate the esophagus. If these measures are not effective, try simple over-the-counter (OTC) antacids such as a generic aluminum hydroxide and magnesium hydroxide product (MAALOX, MAALOX TC). If symptoms worsen or bleeding occurs, call your doctor. If this does not relieve your symptoms, one of the family of stomach acid–blocking drugs known as histamine2-blockers can be tried. This family includes cimetidine (TAGAMET), famotidine (PEPCID), nizatidine (AXID), and ranitidine (ZANTAC). Histamine2-blockers are available in both OTC and prescription strengths. If the OTC histamine2-blockers do not give adequate relief of your symptoms after 14 days, it is time to consult your physician. |
Safety experts from the Foodand Drug Administration (FDA) and the Duke
We last wrote about metoclopramide and the drug’s association with movement disorders in the February 1996 issue of Worst Pills, Best Pills News when we reported on research appearing in the December 13, 1995 Journal of the American Medical Association. In this study, researchers gauged the chance of a patient developing drug-induced parkinsonism and being mistakenly treated for Parkinson’s disease after taking metoclopramide. The result was that at metoclopramide doses greater than 20 milligrams per day, the odds of being treated for Parkinson’s increased by fivefold.
Metoclopramide was approved for sale in the
The FDA and the Duke University experts are very concerned about the possibility of metoclopramide-induced movement disorders, particularly tardive dyskinesia, because the number of prescriptions for metoclopramide has been increasing since cisapride (PROPULSID), also a heartburn drug, was pulled from the market for causing fatal heart rhythm disturbances in March 2000 (see Worst Pills, Best Pills News May 2000). Tardive dyskinesia and other movement disorders associated with the use of metoclopramide are discussed in more detail below. We listed cisapride as a DO NOT USE drug in August 1998, more than one and one-half years before the drug was eventually banned from the market (see Worst Pills, Best Pills News August 1998).
The FDA received 87 reports linking metoclopramide to tardive dyskinesia from the time of metoclopramide’s initial marketing in 1980 through June 2003. These 87 reports may only be a small fraction of the true number of cases of this serious, sometimes irreversible adverse drug reaction, as the FDA estimates that only one in ten serious reactions are ever reported to the agency.
The cases of tardive dyskinesia were mainly in older women whose average age was 60 years. The average daily dose of metoclopramide used was 33 milligrams per day, which is within the recommended dose for the drug. The average duration of treatment in these cases was approximately two years.
In these cases, metoclopramide was most often prescribed for heartburn (30%), followed by diabetic gastroparesis (14%). In an additional 12 percent of the reports, metoclopramide was prescribed for nausea or vomiting or both.
Tardive dyskinesia is a condition consisting of potentially irreversible, involuntary, jerky motions (dyskinetic movements) that may develop in patients treated with metoclopramide. Although the prevalence of the tardive dyskinesia appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients are likely to develop the syndrome. Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase with the length of treatment and the total cumulative dose of metoclopramide.
There is no known treatment for tardive dyskinesia although the condition may lessen, partially or completely, within several weeks to months after metoclopramide is stopped.
Extrapyramidal symptoms are another drug-induced movement disorder that can result from the use of metoclopramide. They occur in about 1 in 500 patients treated with the usual adult dosages of 30 to 40 milligrams per day of metoclopramide. The symptoms 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. The symptoms may include involuntary movements of limbs and facial grimacing, spasmodic contraction of the muscles of the neck, fixation of the eyeballs in one position usually upward, rhythmic protrusion of tongue, difficulty speaking, spasm of the chewing muscles, or reactions resembling tetanus.
Parkinson’s disease like symptoms occur most commonly within the first six months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within two to three months following the discontinuation of metoclopramide. Patients with preexisting Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients may experience worsening of parkinsonian symptoms when taking metoclopramide.
What You Can Do
If you or a family member are taking metoclopramide and uncontrollable movements develop, contact the prescribing physician immediately. See the box below for information on how to report an adverse drug reaction to the FDA.
If you or a family member experiences an adverse effect from a drug, you can report it to the FDA’s MedWatch program. There are several ways for health professionals or consumers to submit MedWatch reports: Online — Go to the MedWatch Web site at www.fda.gov/medwatch/ and follow the instructions for submitting a report electronically. By phone — The toll-free number for reporting to the FDA is 1-800-FDA-1088. By fax — You can submit a completed form to MedWatch’s fax number at 1-800-332-0178. |
