FDA Adds Black Box Warning to Reglan
February 26, 2009 – the U.S. Food & Drug Administration (FDA) added a “Black Box Warning” to metoclopramide-containing drugs, including Reglan tablets, Reglan oral disintegrating tablets, metoclopramide oral solution, and Reglan injections. According to the FDA, “the chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”
More than two million Americans use Reglan which is approved to treat heartburn caused by gastroesophageal reflux in people who have not responded to other therapies and to treat diabetic gastroparesis (slow gastric emptying in people with diabetes). Additionally, Reglan is sometimes used off-label to induce lactation in breastfeeding women with a low milk supply.Reglan works by increasing muscle contractions in the upper digestive tract, thereby speeding up the rate at which the stomach empties into the intestines. Due to the risk of serious Reglan side effects, it is recommended that treatment not exceed three months.
Reglan & Tardive Dyskinesia
The Reglan black box warning will advise consumers about the risk of tardive dyskinesia with long-term or high-dose Reglan use. When used in high doses or for more than 3 months, Reglan may cause patients to develop tardive dyskinesia, which is a movement disorder characterized by involuntary and repetitive movements of the body including lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers.
Unfortunately, symptoms of tardive dyskinesia are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after Reglan treatment is stopped. Those at greatest risk include the elderly, especially older women, and people who have been taking Reglan for a long time.
Reglan Black Box Warning Lawyer
If you or a loved one has experienced serious Reglan side effects, such as tardive dyskinesia, you may be entitled to file a Reglan lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages, and more. Contact us today for a free and confidential case evaluation by one of our experienced Reglan lawyers.
About Bernstein Liebhard
BL is a nationally recognized law firm located in New York City that exclusively represents injured plaintiffs in a variety of individual and class actions. We have been ranked among the top plaintiffs law firms in the country by the National Law Journal for the past nine years–an honor achieved by only one other law firm in the United States. Our experienced Reglan trial attorneys are standing by ready to review your case. We represent our injured clients on a contingency fee basis, meaning that we advance all costs and do not collect any attorneys fees unless we are successful.