The U.S. Court of Appeals for the Fifth Circuit, based in New Orleans, recently denied an argument by Actavis, Inc. – a manufacturer of generic Reglan – that federal law does not allow consumers and users of that specific generic Reglan to file failure-to-warn claims. This particular claim was filed by a woman who now suffers from Tardive Dyskinesia, which is a rare disorder that causes involuntary and repetitive movement of the lower face and extremities.
Actavis manufactures and markets a generic version of the drug Reglan, which is used to treat gastrointestinal disorders. A number of cases are now being filed throughout the U.S. against companies like Actavis that market Reglan, as consumers are complaining that these generic forms are being marketed with little or no warning of the long-term side effects, namely Tardive Dyskinesia. The generic drug companies, however, are arguing that current federal laws absolve them of failure to warn claims. The federal laws state that generic drugs are required to carry the same warning labels of the name brand drugs. However, the Fifth Circuit Court of Appeals disagreed.
The FDA issued a “black box” warning against Reglan (metoclopramide) in February 2009. Reglan is commonly used to treat gastroesophageal reflux disease (GERD) and other stomach conditions in both children and adults. This black box advisory—the strongest advisory that the FDA is able to issue—warns both doctors and patients that people who take Reglan long-term may be at risk for Tardive Dyskinesia, a movement disorder that is frequently irreversible. The elderly and infants are at an increased risk for this serious side effect.
How Reglan Works
Reglan affects the pressure in the lower esophageal sphincter, which aids gastrointestinal emptying and helps prevent reflux and other stomach disorders. Reglan, however, is only approved by the FDA for short-term use of between four and 12 weeks. Despite this fact, doctors often prescribe Reglan to patients on a long-term basis, sometimes for years. While taking Reglan for a short period of time is considered safe, patients who take Reglan beyond the amount of time recommended by the FDA, who are overprescribed Reglan, or who are not properly monitored while on the drug are at increased risk for Tardive Dyskinesia.
Tardive Dyskinesia is a neurological disorder that affects movement, often causing random, involuntary, and repetitive movement. Symptoms of Tardive Dyskinesia include:
• Involuntary and repetitive facial movements such as lip smacking, eye blinking, tongue thrusting, and lip movements.
• Involuntary movement in the fingers, hands, toes, feet, arms, legs, shoulders, and trunk.
• Difficulty walking, talking, breathing, and swallowing
There is no cure for Tardive Dyskinesia, and in many cases it is irreversible. Studies show that as many as one in four patients who take Reglan for more than one year may develop symptoms associated with Tardive Dyskinesia.
Preventing Tardive Dyskinesia
While the amount of Reglan prescribed and the duration of use correlate to the level of risk for developing Tardive Dyskinesia, patients who are on lower doses for shorter periods of time may also develop the disorder.
The best way to reduce the risk of Tardive Dyskinesia is to be fully aware of the benefits and risks of Reglan, and to take it only when the benefits outweigh the risks. In addition, Reglan should be taken no longer than 12 weeks, according to FDA recommendations. Doctors should be aware of the symptoms of Tardive Dyskinesia, and should monitor the patient frequently. Even if no symptoms are present and the patient seems to tolerate Reglan, it should be discontinued beyond the short term, as symptoms frequently surface only after the drug is stopped. If any symptoms become evident while Reglan is being used, it should be discontinued immediately.
If you or a loved one has taken Reglan and has experienced Tardive Dyskinesia, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with Reglan. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.