Prescription Drug Reglan Investigation

Millions of people in the United States suffer from gastrointestinal problems, and as a result, companies from all over the world have poured resources into the research and development of medications designed to treat the symptoms of the different gastrointestinal maladies.

One of the leading products brought to market in the United States in recent years that helped patients deal with gastrointestinal tract issues was Reglan. Reglan was first manufactured by A. H. Robins Company, Inc., which later sold it to Wyeth Pharmaceuticals.  In 2001, Wyeth sold the rights and liabilities of Reglan to Schwarz Pharma, Inc. 
Generic metoclopramide is manufactured and distributed by numerous companies, including Teva McKesson Packaging, Rugby, Quality Care Products and URL Pharma.  Reglan is the trade name used by the manufacturer for the generic metoclopramide.

Stueve Siegel Hanson is investigating the drug and its link to an increased risk of extrapyramidal symptoms (EPS) injuries.  The drug can come in the form of a tablet, an injection, or syrup.

Reglan was originally used to treat psychiatric patients in the 1950s. The discovery of its impact on heartburn and diabetic gastroparesis lead to a widening of its indications.

Reglan (metaclopramide) was approved by the FDA in 1986 to treat gastrointestinal problems such as heartburn, gastric reflux, nausea associated with migraines or cancer treatments, and pregnancy-related morning sickness. It is also used to assist infants in the digestion of formula. Over two million prescriptions have been written for Reglan in the U.S. since its FDA approval.

The drug works by targeting parts of the nervous system and tightening certain areas of muscles while relaxing others, allowing movements and contractions of the stomach and upper intestine to facilitate movement of food.

FDA Warning

In February of 2009, the U.S. Food and Drug Administration (FDA) announced that manufacturers of Reglan and other metoclopramide containing drugs must add a boxed warning to their drug labels about the risk of tardive dyskinesia with long-term or high-dose use of the drug.

Tardive Dyskinesia is a very serious disorder that causes involuntary, repetitive tic-like movements primarily in the facial muscles or (less commonly) the limbs, fingers and toes - also known as extrapyramidal symptoms (EPS). The hips and torso may also be affected. Tardive means “delayed” and dyskinesia means “abnormal movement.” Symptoms may include involuntary facial grimacing, jaw swinging, repetitive chewing and tongue thrusting. Tardive dyskinesia can appear similar to other types of disorders, most notably Tourette’s syndrome.

These involuntary movements resulting from exposure to Reglan or similar drugs can sometimes persist even after the drug is discontinued.  Reglan has also been associated with nervous system disorders, depression with suicidal ideation, visual disturbances, and memory loss. 

 There is no known standard treatment for tardive dyskinesia. People who develop the condition will require ongoing, complicated treatment and may become physically and vocationally disabled.

The FDA also ordered a ‘REMS’ study, which stands for risk evaluation and mitigation strategy. This basically means that a study must be performed that measures whether or not the risks of allowing Reglan to remain on the market outweigh the benefits. This study and the “Black Box” warning represent the two most severe sanctions available to the FDA short of a recall.

Reglan side effects don’t just affect the user physically—they have a detrimental effect in terms of the user’s emotions, social interactions, and financial obligations. Many who suffer from serious Reglan side effects lose the will and ability to function in social situations and at work, and some even lose touch with family as a result. There are also Reglan side effect victims who feel trapped in their homes and start to behave like a recluse because of the severity of the symptoms. The majority of these symptoms have no cure and may incur ongoing costs such as rehabilitation services or speech therapy. Such long term care is obviously an enormous cost over a lifetime.

Our law firm is currently investigating cases in which our clients have sustained any of the symptoms or injuries listed above.  If you or someone you know has experienced serious side effects caused by Reglan and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.

 

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