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

Salix Pharmaceuticals

Salix received FDA approval for Metozolv last September, offering an alternative to the metoclopramide pill known by the brand name Reglan. Reglan received a black box warning from the FDA last year after long-term (12 weeks or more) use of Reglan was linked to a serious involuntary movement disorder known as Tardive Dyskinesia.

As another version of metoclopramide, Metozolv is also required to carry the same warning on its label and provide adequate warnings of the serious side effect in its marketing materials. By not doing so, the FDA said, “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

However, the warning did not affect the company’s stock, which rose $1.74 last week to close at $37.41. If Salix does not correct the violations, the company could face FDA regulatory action.

SOURCE: Reglan Side Effects › Salix stock soars despite FDA warning letter

Clinical trials are medical research studies involving people that seek to prevent disease, find treatments, diagnose diseases, or control symptoms. Trials on experimental drugs, such as the GERD study, aim to identify if the drug is safe, has side effects, works better than currently used treatments, and helps users feel better. Experimental drugs are not tested on people unless they show promising results in laboratory tests.

GERD is a chronic condition in which the liquid contents of the stomach regurgitate or back up into the esophagus. This liquid can inflame and irritate the lining of the esophagus, causing symptoms such as heartburn, sour taste in the back of the throat, a dry cough and interrupted sleep. If left untreated, it can also lead to esophageal cancer.

Treatments include diet changes and medication. While many drugs are available over-the-counter to treat heartburn, more potent prescription alternatives are limited. One common prescription treatment is Reglan (metoclopramide), however the drug carries an FDA black box warning of a serious, involuntary movement disorder known as Tardive Dyskinesia. For sufferers of GERD, identifying a safe and effective treatment could be life changing.

SOURCE: Reglan Side Effects › Participants needed for clinical trial on new GERD treatment

Hiccups are usually a short-lived condition, with bouts lasting no longer than 30 hiccups. While the cause is relatively unknown, some things can trigger an episode of the hiccups, such as an overly full stomach (from too much food, alcohol or air), sudden temperature changes, smoking cigarettes, excitement or stress, and some medications. But for some, hiccups can last hours or even days. One man in Iowa reportedly had hiccups that lasted 60 years. Constant hiccups can make eating, drinking and sleeping difficult, and may require medical treatment to get under control.

If you suffer from hiccups that last an unusually long time, seek medical attention. Your doctor may first want to rule out any underlying medical conditions. While unlikely the case, constant hiccups may be a symptom of a more serious problem, such as laryngitis, gloiters, tumors in the neck, infections near the diaphragm, hiatus hernia, kidney failure, ear infection, aortic aneurysms and multiple sclerosis.

While rarely performed, hiccups can be treated with surgery. One type of surgery involves a nerve block that stops the major nerve supply for the diaphragm from sending signals to the diaphragm. The other involves implanting a pacemaker into the diaphragm to control contractions in the diaphragm. Most doctors, however, will choose a less invasive route, which may include medications.

Drugs that have been shown to reduce hiccups are the antipsychotic chlorpromazine, antispastic medication baclofen and metoclopramide. While medications may offer relief, patients should be aware of any serious side effects. For example, metoclopramide carries an FDA black box warning about the risk of a serious movement disorder known as Tardive Dyskinesia.

If your hiccups are persistent, don’t sit back and suffer. Consult with your doctor about the right treatment for you.

Source: MSN Health

SOURCE: Reglan Side Effects › Reglan may stop hiccups, but may cause more serious problems

More and more cases of consumers taking metoclopramide and subsequently developing Tardive Dyskinesia were reported to the Food and Drug Administration (FDA), and by early 2009, the agency had ordered a black box warning be placed on the medication. New warnings and precautions were written into the drug’s packaging that included an up to 20 percent risk of patients developing Tardive Dyskinesia during long-term use of the medication.

But the warnings came too late for Conte, and for her doctor, who she alleges was unaware of the risks because Reglan’s maker, Wyeth, disseminated misleading and/or incomplete warnings about the drug’s side effects. She sued Wyeth, claiming the company knew of a widespread tendency among physicians to mis-prescribe Reglan and generic metoclopramide for long periods of time even though the medication is only approved for 12 months of use. The drug’s labeling, her lawsuit claimed, substantially understated the risks of serious side effects from extended use.

Initially, the trial court ruled in favor of Wyeth, which argued that it was the physician’s duty to warn patients of any ill effects drugs may have on patients. Conte appealed, arguing the drug’s manufacturer should be responsible. The Court of Appeal concluded that Wyeth was obligated to disseminate accurate product warning labels.

Source: Sierra Sun

SOURCE: Reglan Side Effects › Women suffering from movement disorder sues Reglan maker Wyeth

Last month, the FDA issued a black box warning on the injectable form of promethazine hydrochloride. Promethazine hydrochloride, once sold under the now-discontinued brand name Phenergan, is available in generic formulations in the form of tablets, liquid, rectal suppository, intravenous injection and intramuscular injection. The black box warning cautions health care providers against administering the IV injection into an artery or under the skin because gangrene or other severe tissue injury can result. It also can leach out from the vein during IV administration, causing serious tissue damage.

Another anti-nausea medication is metoclopramide, known by the brand names Reglan and Metozolov. The drug can be administered by injection, or taken as a pill by mouth. Metoclopramide is also a treatment for gastrointestinal conditions such as gastroparesis and GERD. Earlier this year, an FDA black box warning was placed on metoclopramide after long-term use of the drug was linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia.

Tardive Dyskinesia is identified by involuntary head jerking, eye blinking, facial grimacing, pucker and pursing of the lips, lip smacking and tongue thrusting. It may also involve involuntary movements of the fingers and hands. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

SOURCE: Reglan Side Effects › Anti-nausea drugs carry black box warnings

The patient suffers fro gastroparesis, a condition in which the stomach empties its contents too slowly. It often affects people with diabetes. However, in as many as 60 percent of children with the condition, the cause is unknown.

The procedure involves inserting the pacemaker into the abdomen and placing the electrical wires attached to the device on the stomach. Electrical impulses stimulate the stomach after eating, encouraging the stomach to empty its contents.

“The initial settings are fairly low and, as with a pacemaker in the heart, we can change the settings as needed,” said pediatric surgeon Steven Teich, MD, surgical director of the Bariatric Surgery Program at Nationwide Children’s Hospital and clinical assistant professor of surgery at The Ohio State University College of Medicine.

Pacemakers have been used to treat gastroparesis in adults and results have been promising. “In patients who have received this type of treatment, nearly all symptoms were resolved within two weeks,” said said pediatric gastroenterologist Hayat Mousa, MD, medical director of the Motility Center at Nationwide Children’s Hospital and Associate Professor of Clinical Pediatrics at The Ohio State University College of Medicine.

The procedure takes the place of other, less effective treatments, commonly the medication metoclopramide known in the U.S. by the brand name Reglan. Reglan can only be used for short terms, as long-term use has been linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Earlier this year, the Food and Drug Administration (FDA) placed a black box warning on the medication alerting patients and health care professionals of the serious risk when using the medication for more than 12 weeks.

Other medications used to treat gastroparesis include antibiotics, which also carry a list of side effects. “None of these options are really that effective. Hence, the need for better treatment with the gastric pacemaker,” says Dr. DiLorenzo, Chief of Gastroenterology at Nationwide Children’s Hospital.

Source: DotMed News

SOURCE: Reglan Side Effects › Procedure shows promise versus drugs for children with gastroparesis