Wyeth and Schwarz originally developed the brand-name metoclopramide, Reglan. They were released from litigation by U.S. District Judge Marcia A. Crone. The case is expected to be ready for trial by January 2011.

Metoclopramide is a medication approved by the Food and Drug Administration (FDA) in 1989 to treat gastrointestinal conditions such as severe heartburn, gastrointestinal reflux disease (GERD) and gastroparesis, or delayed emptying of the stomach contents. Over the years, the FDA has received numerous reports of users of metoclopramide suffering from Tardive Dyskinesia, and last year the agency issued a black box warning on metoclopramide products warning users that long-term use of the drug – 12 weeks or more – considerably raised one’s risk of developing the movement disorder.

Tardive Dyskinesia is a condition in which a person develops involuntary movements of his muscles. These movements include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips, and involuntary movements of the fingers. Symptoms often continue even after the drug has been discontinued. To date, several lawsuits have been filed in courts throughout the U.S. against the makers of Reglan and generic metoclopramide.

SOURCE: Reglan Side Effects › Generic Reglan makers released from Tardive Dyskinesia lawsuit

When we first told you about Mary, she was gearing up for an innovative surgery that would place a device called the Enterra into Mary’s abdomen. Her doctor, Richard McCallum, founding chair at the Paul Foster School of Medicine at Texas Tech University, called it a very powerful anti-nausea, anti-vomiting tool. For Mary, it was a glimmer of hope. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” she said. 

Milder cases of gastroparesis can be treated through diet changes, however many sufferers must turn to medications such as Reglan (metoclopramide). But medication is not always an option for patients who must be on them for several months or years. Reglan has a black box warning against long-term use of the drug (more than 12 weeks) because it can cause a serious movement disorder known as Tardive Dyskinesia.

For Mary, surgery seemed to be the most logical solution.

Just days after surgery, Mary told News Channel 9 that her dreams were realized. She is able to eat and drink things she wouldn’t have even dared to try before surgery. “I’ve been eating ice cream every night, so it’s a whole new world,” she said.

SOURCE: Reglan Side Effects › Gastroparesis sufferer finds relief through surgery

Mary suffers from gastroparesis, a condition in which the stomach takes too long to empty its contents. It is a debilitating condition that can strike anyone, but people with diabetes are more susceptible. As many as 50 percent of people with type 2 diabetes and 20 percent with type 1 diabetes have the gastrointestinal disorder.

Treatment for gastroparesis can be discouraging. Some people can manage the condition by limiting their diet. Others must rely on medications, such as Reglan (metoclopramide), which can have serious side effects such as a involuntary movement disorder known as Tardive Dyskinesia.

With little hope left, Mary chose another option – to have an innovative new surgery available at Texas Tech University’s Paul Foster School of Medicine. As part of the surgery, doctors will implant a device called the Enterra into Mary’s abdomen. “It’s a very powerful anti-nausea, anti-vomiting tool,” gastroneurologist Richard McCallum, founding chair at the Paul Foster School of Medicine, told KTSM-TV.

Mary’s surgery will be third of its kind performed at the El Paso medical center. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” Mary said.

SOURCE: Reglan Side Effects › Woman to have innovative new surgery to treat gastroparesis

GERD is a condition thought to be the result of an acid burn caused by stomach acid splashing up into the esophagus. It is often treated with medications that reduce stomach acid, such as Reglan (metoclopramide). But the new study squashes the “acid burn” belief. “Chemical injuries develop immediately,” the study’s leader, Dr. Stuart Spechler, told Reuters. “If you spill battery acid on your hand, you don’t have to wait a month to see the damage.”

Researchers say that the findings from the new study could change the way GERD is treated. “Currently, we treat GERD by giving medications to prevent the stomach from making acid,” said Dr. Rhonda Souza. “But if GERD is really an immune-mediated injury, maybe we should create medications that would prevent these cytokines from attracting inflammatory cells to the esophagus and starting the injury in the first place.”

An estimated 40 percent of Americans experience symptoms of GERD at some point, and as many as 20 percent suffer from persistent symptoms. If left untreated, GERD can cause esophageal cancer.

SOURCE: Reglan Side Effects › New study may lead to different treatments for GERD

Patients who suffer from regular vomiting, stomach pain or trouble swallowing are usually given diagnostic tests such as endoscopies, biopsies and CT scans. Some patients are sent to other cities for more advanced testing. With the opening of El Paso’s new clinic, patients who suffer from serious gastrointestinal conditions have more options for specialized care.

“Rather than sending patients to the Mayo Clinic, we can take care of them right here,” says Dr. Richard McCallum, a gastroenterologist and chairman of the Department of Internal Medicine at El Paso’s medical school, in an interview with the El Paso Times. “We offer a very cutting-edge array of the best tests to diagnose the disorders.”

These tests include an esophageal motility test to measure the muscles and pressure of the esophagus; and a gastric emptying test and an ingestible SmartPill, both of which monitor how quickly food leaves the stomach. “These are a series of tests the average hospital and (doctor’s) office do not have,” Dr. McCallum says.

The center will also conduct medical students for new drugs and treatments for various gastrointestinal conditions, including gastroparesis, a condition in which the stomach empties its contents too slowly causing pain, disability and nutritional problems for those who suffer from the condition.

SOURCE: Reglan Side Effects › New medical center to focus on gastrointestinal disorders

Kecia Neal

Last month, Neal filed suit against Teva Pharmaceutical, Schwarz Pharma and Wyeth Inc., makers of Reglan and its equivalent metoclopramide, after she began experiencing involuntary and repetitive movements of her body and face known as tardive dyskinesia. The condition is debilitating, and often continues even after the medication has been discontinued.

In February 2009, the Food and Drug Administration (FDA) ordered Reglan’s manufacturers to provide an additional boxed warning that “chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement that is often irreversible.” The new warnings state that “prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases,” however those warnings came far too late for Neal.

According to the lawsuit, patients who take Reglan for more than 12 weeks are at a 100 times greater risk for developing the disorder and other side effects.

Neal, who was on Reglan for more than a year, says she did not have access to the warnings about taking Reglan long-term. As a result, she is suffering from permanent and debilitating injuries. The lawsuit seeks damage for past and future medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, disability, psychological injury, loss of ability to provide household services, loss of earnings, and loss of earning capacity.

The case is expected to become part of a multi-district litigation.

Source: Southeast Texas Record

SOURCE: Reglan Side Effects › Woman files suit against Reglan for causing serious movement disorder