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The new chewable heartburn medication Metozolv, an orally disintegrating version of Reglan (metoclopramide), has added a warning to its label alerting users of a risk of the serious movement disorder Tardive Dyskinesia with long-term use of the drug. The change to the drug’s safety label was approved by the Food and Drug Administration (FDA) and announced this month.
Salix Pharmaceuticals stock rose 5 percent last week despite news that the company received a warning letter from the Food and Drug Administration (FDA) urging the company to clarify information about its new orally dissolving heartburn treatment, Metozolv ODT, according to Local Tech Wire. The FDA said that some of the drug’s marketing materials are “false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”
The Food and Drug Administration (FDA) has fired off a warning letter to drug maker Salix Pharmaceuticals arguing that some of its marketing materials for Metozolv, an orally dissolving form of metoclopramide for the treatment of acid reflux conditiosn, “are false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”
The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”
The Food and Drug Administration (FDA) has approved a generic version of a drug for treating gastroesophageal reflux disease, or GERD, in adolescents and adults. Amneal Pharmaceuticals’ nizatidine oral solution was approved in the 15-mg-per-15-ml strength, and is a generic version of Axid, made by Braintree Laboratories. The medication belongs to a class of drugs known as histamine H2 blockers.
Salix Pharmaceuticals’ new gastrointestinal disorder treatment Metozolv (metoclopramide) OTC (orally disintegrating tablet ) utilizes Zydis, a fast-dissolve technology made by Catalent Pharam Solutions. Zydis is a unique, freeze-dried oral solid dosage form that can be swallowed without water because it dissolves instantly on the tongue in less than three seconds, according to Catalent. This delivery method translates to dosing convenience and ease of administration that makes taking medication easier for patients.
Metoclopramide, known in the U.S. by the brand names Reglan and Metozolv, is a commonly prescribed medication used in the treatment of serious gastrointestional disorders, such as GERD and gastroparesis. Earlier this year, a study suggested that the medication may also help women suffering from morning sickness, in particular a severe form marked by serious vomiting called hyperemesis gravidarum. The study, which involved more than 80,000 births to Israeli women, found that women who took the medication while pregnant did not raise the risk of harming their unborn child.
There is no known cure for Tardive Dyskinesia, a serious movement disorder linked to some psychiatric drugs and metoclopramide, a medication used to treat heartburn, GERD, and other gastrointestinal disorders. The condition, identified by involuntary movements such as jerks, eye blinking, and muscle contractions of the face and limbs, usually develops after long-term use of the medications. Symptoms often persist even after the medication has been stopped. Use of the drugs that cause Tardive Dyskinesia also can mask symptoms, which can mean symptoms become more pronounced after the medication stops.
People with movement disorders that are inherited or caused by infection or other occurrences, such as Parkinson’s disease, have a bevy of resources available. But for those whose debilitating condition came as a result of medication have little support. The National Empowerment Center, an organization dedicated to those with mental illness, is raising awareness and educating the public about such conditions in hopes to change that trend.
The medication metoclopramide, used in the treatment of some gastrointestional conditions, has received much press lately. Earlier this year the drug fell under a black box warning by the Food and Drug Administration (FDA) after studies showed that patients who took the prescription medication were at high risk of experiencing involuntary movements of their face, hands and torso. The condition, known as Tardive Dyskinesia, is a debilitating disorder that often doesn’t go away even after the offending medication has been discontinued. The result has been measured in countless lawsuits against manufacturers of metoclopramide.
Salix Pharmaceuticals, Ltd., makers of medicines for various gastrointestinal ailments, has received marketing approval from the Food and Drug Administration (FDA) for Metozolv ODT for the treatment of both diabetic gastroparesis and symptomatic documented GERD. Metozolv ODT is an orally disintegrating metoclopramide tablet. Metoclopramide was previously only available in the United States in a pill form under the brand name Reglan.
