Diabetics

The study is being conducted at institutes in 37 cities in numerous states across the country. Additional criteria to participate includes being 18 years of age or older and free of cancer for five years. Qualified participants will receive all study-related exams and investigational study medication at no cost. Compensation is also provided.

Currently, there are few options for patients who suffer from the painful and often debilitating symptoms of gastroparesis. A restricted diet may help some, but many turn to medications or surgery to help them lead normal lives. However, surgery can be invasive, and even the most common medications to treat gastroparesis, such as Reglan (metoclopramide), come with an FDA black box warning that the drug has been linked to a serious and involuntary movement disorder known as Tardive Dyskinesia. There is no cure for Tardive Dyskinesia and symptoms often persist even after the medication has been stopped.

Clinical trials are medical research studies involving people. The trials look at preventing disease, treatments, diagnosing disease and controlling symptoms, and seek to determine if a new experimental drug or procedure is safe, has side effects, works better than the currently used treatment, and helps patients feel better. New treatments must be thoroughly tested first in the laboratory and then in people before they are approved by the FDA.

For more information about and locations for the nationwide Diabetic Gastroparesis Clinical Trial, visit the Clinical Connection.

SOURCE: Reglan Side Effects › Clinical trial seeks diabetics for new gastroparesis treatment

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

Some studies show that patients who take the medications for more than 12 weeks, as well as the elderly, are as much as 20 to 70 percent at risk for developing Tardive Dyskinesia. Medications like Reglan (metoclopramide) may mask the symptoms, which can become more prevalent after the medication is discontinued. Even after patients stop taking the drugs, symptoms may persist.

Symptoms include involuntary lip smacking, blinking, raising eyebrows, tongue twitching and protrusion, toe tapping, and jerking, repetitive, involuntary motions of the fingers, hands, arms, legs and/or torso. For some, the movements are slight and hardly noticeable. For others, the involuntary movements are severe and debilitating.

Unfortunately, there is no way to predict who will suffer the symptoms of Tardive Dyskinesia, which makes it even more important that patients understand the risks of their medication. Recently, the Food and Drug Administration (FDA) issued a black box warning, its most serious warning, on Reglan (metoclopramide) because of the risk of Tardive Dyskinesia especially with long-term use of the medication. An estimated two million people take some form of Reglan (metoclopramide), and may be at risk for developing the movement disorder.

SOURCE: Reglan Side Effects › Movement disorder linked to common medications

Dr. David Carroll of Surgical Specialists of Jackson, Miss., offers a completely noninvasive procedure to treat GERD that requires no injection, cutting or penetration of the skin. It is called transoral incisionless fundoplication (TIF) surgery with the EsophyX device. Dr. Carroll says he has performed the procedure many times laparoscopically over the past 15 years, but the new EsophyX device allows him to perform the surgery using an endoscope inserted through the patients’ mouths.

“It developed over the last several years. The results are really good,” Dr. Carroll told the Clarion Ledger. He performed the first TIF with the EsophyX in Mississippi on 46-year-old Connie Braswell of Pearl, Miss. Braswell had treated her GERD symptoms for years with Nexium, but last year her symptoms worsened. “It got to the point where I was burping every day, all day long. It was very irritating,” she says.

Two gasterenterologists and two general practitioners tried her on various medications, including Reglan (metoclopramide), but nothing worked. She began restricting her diet, giving up dairy products, spicy food, coffee, and her beloved Dr. Pepper. She shed 28 pounds in the process, but she wasn’t happy. She missed the foods she used to enjoy.

Then Dr. Carroll told her about the new, noninvasive procedure using the EsophyX device, and it changed her life. “I prayed and prayed to get better and nothing else worked,” she says. “and this is working.”

Pictured are Dr. David Carroll, Dr. Jeffrey Glover and Dr. David Miller of Surgical Specialists of Jackson.

SOURCE: Reglan Side Effects › Non-surgical procedure offers hope to patients with GERD