Boxed Warning Required for Metoclopramide
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The FDA has requested that the drug metoclopramide be accompanied with a black box warning, the agency's most forceful warning before the drug is recalled. Metoclopramide has been used to treat gastrointestinal disorders, such as gastroesophageal reflux disease (GERD) and diabetic gastroparesis. The drug is used by over two million Americans in its generic form, as well as sold under brand names. These include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution and Reglan Injection. However, it has been linked to a serious irreversible condition called tardive dyskinesia.
Gastroesophageal Reflux Disease
Gastroesophageal reflux disease (GERD) occurs when the contents of the stomach rise into the esophagus several times a week. It is commonly known as acid reflux or gastroesophageal reflux (GER), and causes a burning sensation in the chest or throat. Occasionally food or fluid can be tasted at the back of the throat. GER and GERD are two separate things, and should not be confused. However, GERD can lead to more serious problems, and can occur at any age. It can be caused by lifestyle factors, such as smoking or obesity, or by eating certain foods, like fatty, fried, spicy, and tomato-based foods.
Metoclopramide is a dopamine receptor antagonist, which is a fancy way of saying it blocks dopamine. It is also commonly used to treat vomiting and nausea. The drug helps to strengthen the lower esophageal sphincter to keep stomach acid from moving up the esophagus. It also stimulates the stomach muscles to move food quickly into the intestines. This is particularly helpful with people who have diabetes and whose stomach nerves are damaged. Nausea, vomiting, abdominal distention and a sense of fullness, as well as heartburn are common in people with this condition.
Though there are several side effects of taking metoclopramide, tardive dyskinesia is the most serious. Those who take metoclopramide for more than three months are the most likely to develop this condition.
Tardive Dyskinesia is a condition characterized by involuntary and rapid movements of the body. It is a side effect of using dopamine antagonists for long periods of time, and is usually associated with antipsychotics. It has existed for over half a century, but it is not known exactly why some people develop it, while others don't. Features of those with tardive dyskinesia are:
- Lip smacking
- Rapid blinking of the eye
- Constant movement and protrusion of the tongue
- Puckering and pursing of the lips
- Impaired finger movement
The FDA has requested that those who are taking metoclopramide contact their doctor immediately. If you have developed tardive dyskinesia as a result of taking metoclopramide, please contact an experienced pharmaceutical injury lawyer in your area.