Symptoms of GERD include heartburn, or a burning sensation under the breastbone, burning in the back of the throat due to regurgitation of stomach acid, nausea and vomiting. If left untreated, GERD can result in painful inflammation or ulcers in the esophagus, scar tissue in the esophagus, Barrett’s esophagus, cough and asthma, inflammation and infection in the lungs, inflammation of the throat and larynx, and even fluid in the sinuses and middle ears.

Currently, there are few safe and effective treatments for GERD, and some prescription medications to treat the condition, such as Reglan (metoclopramide) now carry a black box warning by the Food and Drug Administration (FDA) for side effects that include the risk of developing tardive dyskinesia, a neurological disorder that causes involuntary movements of the muscles in the face, arms and torso.

In order to qualify for the medical study, participants must be 18 to 65 years of age and currently be taking an FDA-approved dose of heartburn medication. Qualified participants will receive lab work, study related medical care and medication, and $600 for completion of the study.

For more information or to sign up for the study, visit the GERD study page at the Clinical Connection’s website.

SOURCE: Reglan Side Effects › GERD sufferers sought for study on investigational heartburn treatment

The numerous responses tell the same story. “My experience with Reglan was absolutely frightening,” says SoCal. “I developed severe Parkinson’s-like tremors and anxiety. And, I don’t even have a history of anxiety. I stopped the drug immediately and was told never to take it again.”

“I had the same experience as SoCal with Reglan,” says Natie. “I developed severe anxiety and tremors within the first day of taking it.”

“I had the same exact experiences,” Miss Lady Bug chimes in. “I stopped taking it but was left with permanent nerve damage. I had to go to Mayo Clinic to find that out,” she says. “Mayo told me that Reglan should be outlawed and that the USA is the only country that even still uses it.”

Reglan was approved by the Food and Drug Administration (FDA) for the treatment of severe heartburn, acid reflux and gastroparesis. After numerous reports of people using Reglan who then developed tardive dyskinesia, the FDA last year added a black box warning to the drug’s safety label. That warning comes too late for many users of Reglan, who are left with the disabling symptoms of tardive dyskinesia, which include lip smacking, tongue thrusting, eye blinking and bulging, and puckering and pursing of the lips, to name a few.

“I would give anything to be able to go back and do it all over again,” Miss Lady Bug says. “The trembling and anxiety was sooo bad.”

SOURCE: Reglan Side Effects › Forum discusses side effects of heartburn drug Reglan

Tardive Dyskinesia is caused by the long-term use of drugs that block dopamine receptors known as dopamine-receptors antagonists or DRAs. Most of the drugs in this category are anti-psychotics used to treat schizophrenia and other mental disorders.

Recently another medication was added to the list of drugs that increase the risk of developing Tardive Dyskinesia – metoclopramide, known by the brand name Reglan. Reglan is a DRA used to treat gastrointestinal disorders ranging from nausea and heartburn to severe acid reflux and diabetic gastroparesis. Reglan now carries a Food and Drug Administration (FDA) boxed warning against long-term use of the drug because of the risk of developing Tardive Dyskinesia.

The condition can be difficult to diagnose because the medications that cause the disorder can also mask the symptoms. Coming off the offending medication can cause symptoms to surface or even improve. But for some, the debilitating symptoms can be permanent. There is no cure for Tardive Dyskinesia, but some have found relief by taking vitamin E, botulinu toxin injections or by taking certain drugs.

If you have questions about any of these medications or are concerned about symptoms you are experiencing, contact your health care professional.

SOURCE: Reglan Side Effects › Drugs that block dopamine receptors can cause Tardive Dyskinesia

Reglan was approved by the Food and Drug Administration (FDA) for the treatment of gastrointestinal conditions such as chronic heartburn, severe acid reflux or GERD, nausea, and gastroparesis. One year ago, after numerous reports of people using Reglan developed the often permanent and debilitating movement disorder, the FDA placed a black box warning on the drug warning physicians and consumers that using Reglan increased one’s risk of developing Tardive Dyskinesia. A black box warning is the strongest warning the agency can give and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse effects.

But Reglan also carries under the WARNINGS AND PRECAUTIONS section of its safety label a risk of developing depression. Some cases are mild, but others can be quite severe and may involve suicidal thoughts or behaviors. Because of this, consumers should tell their health care provider if they have depression or a history of depression. People who are prescribed Reglan should also be monitored for any signs of depression.

If you or someone you know is taking Reglan and has concerns or questions about the medication, contact your health care professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Reglan Side Effects › Using Reglan can make you depressed

The drug trend report looked at prescription drug spending growth between 2001 and 2009 and found that prescription drug use among children has grown four times higher than the overall population. More than one in four insured kids and nearly 30 percent of adolescents (10-19 years of age) took at least one prescription medication to treat chronic conditions.

The most substantial increases were seen in the use of antipsychotic, diabetes and asthma drugs over the past nine years. But drugs to treat hypertension and gastroesophageal reflux disease, or GERD, have climbed as well. The number of children and infants taking some form of prescription heartburn medication to treat GERD or colic increased by a startling 147 percent.

How safe are these medications for children? A study published last week in The Archives of Internal Medicine shows that use of these drugs increases the risk of infection by Colstridium difficile, a harmful intestinal bacteria. And some medications can have even more dangerous side effects.

For example, the prescription drug Reglan (metoclopramide), used to treat severe heartburn and GERD in both adult and pediatric patients, carries a black box warning that long term use may cause patients to suffer from Tardive Dyskinesia, a severe movement disorder. The drug can mask symptoms of the condition, which can get worse and even linger long after the medication has been discontinued.

SOURCE: Reglan Side Effects › More children taking prescription drugs to treat chronic conditions

Cancer of the esophagus is one of the 10 most common cancers, yet there is no good treatment for the disease. Most people who have been diagnosed with esophageal cancer also have a long history of heartburn. Heartburn occurs when toxic acid from the stomach splashes up into the esophagus. Over time, if left untreated, this constant bathing of stomach acid can damage tissue in the esophagus, a condition known as Barrett’s esophagus.

Barrett’s esophagus is generally treated with the same medications used to treat heartburn and GERD, including Reglan (metoclopramide).

The damaged tissue of Barrett’s esophagus cannot be reserved and if left untreated can lead to esophageal cancer. It is also impossible to remove the damaged tissue, which means the risk of cancer is always a threat.

However, Hans Clevers of the Hubrecht Institute had a hunch. He believed that since the cells in Barrett’s esophagus are very similar to the cells that line the colon, they might share some qualities that could lead to a better understanding in the treatment of Barrett’s esophagus. Researchers determined that the anti-Alzheimer’s drug DBZ, currently in clinical trials, had side effects that affected the lining of the lower colon. Using rat models, Clevers observed the effects of DBZ on Barrett’s esophagus tissue and found that the drug not only halted the growth of Barrett’s esophagus, in some cases it also completely destroyed the mutant tissue.

The treatment is far from human trials, but it still offers hope for a better treatment for Barrett’s esophagus and esophageal cancer in the future.

SOURCE: Reglan Side Effects › Alzheimer’s drug may treat Barrett’s esophagus, esophageal cancer

In a Phase IIb trial, Addex’s ADX10059 increased performed well in the treatment of gastroesophageal reflux disease (GERD). The four-week trial, which comprised 103 patients, showed ADX10059 significantly increased the number of symptom-free days for patients that took the drug compared to patients on a placebo. Patients involved in the trial had previously responded well to a group of drugs widely used for combating acid reflux called proton pump inhibitors, (PPIs).

The trial also showed that the medication was well tolerated among those in the trial. While adverse events were reported more often among those taking ADX10059 than the placebo group, the company reports that the vast majority of events were mild and none were described as severe. Participants who took ADX10059 also indicated a reduction in sleep disturbance compared to those in the placebo group, according to a patient questionnaire.

Addex says it has also completed patient recruitment for another trial of ADX10059, which combines the medication with PPIs. Results on that trial are expected in January 2010.

The results set Addex up to license the drug to a larger pharmaceutical company, which is anticipated sometime in 2010. Some estimates say a partnership could generate as much as $1.25 billion in annual sales.

Source: Addex Pharmaceuticals

SOURCE: Reglan Side Effects › New heartburn medication meets expectations in drug trial

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