For several months, Gentrie was unable to eat solid food, and in at least one occasion was rushed to the hospital for her severe vomiting and dehydration. It wasn’t until she was had a CAT scan that doctors finally discovered the cause of her painful condition. Gertie was diagnosed with pediatric gastroparesis, a condition in which the stomach takes too long to empty its contents. Gastroparesis is often associated with diabetic patients. Doctors believe Gertie’s condition was triggered by a virus.

There are few treatments for severe gastroparesis. It is often treated with medications such as the prescription drug Reglan, also known as the generic metoclopramide. But Reglan carries a risk of severe side effects, especially with long-term use. The drug now carries a black box warning of the risk of developing a neurological disorder known as Tardive Dyskinesia in which the muscles move involuntarily.

Gertie was treated with various medications, including Botox, but nothing seemed to help. She was even fitted with a gastric tube to help her gain weight, but her frail body rejected it six times. As a last resort, doctors decided on a new treatment, implanting in her a gastric pacemaker that would trigger her stomach muscles to contract and encourage digestion.

With the help of singer Miley Cyrus, Gentrie’s family raised enough money to cover the cost of the pacemaker. It was implanted in July and just last week, Gentrie was finally able to have her first meal in eight months. What did she choose to eat? A Wendy’s hamburger.

SOURCE: Reglan Side Effects › Teenager finally finds relief from gastroparesis

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

“This is a significant finding, as it shows that loss of the enzyme that makes carbon monoxide is the actor in this process and that it provides us with a clear approach toward a possible new therapy for this condition,” says Gianrico Farrugia, M.D., Mayo Clinic gastroenterologist and lead investigator on the study, in a Science Daily report.

Gastroparesis is a serious condition that causes pain, nausea, vomiting, stomach spasms, weight loss and nutritional deficiencies. It is usually treated through diet, medication or surgery. Treatments are often unreliable or not recommended for long-term use. Finding a way to reverse the condition would give hope to millions of people who are suffering from the effects of gastroparesis.

As part of the study, researchers studied 10 mice that exhibited delayed gastric emptying. Five were given carbon monoxide by inhalation (100 parts per million) for six hours daily. Within three weeks, gastroparesis was reversed in the mice who received the therapy. While the metabolite that normalizes gastric functioning was not known, using carbon monoxide to treat the mice was a hunch on the part of scientists based on previous studies by the team that showed that gastroparesis is associated with the loss of up-regulation of the heme oxygenase-1 (HO1) and an increase in oxidative stress. In the previous study, the team noted that when they induced HO1 production signs of oxidative stress dropped and gastroparesis was restored.

SOURCE: Reglan Side Effects › Study may lead to new treatment of gastroparesis

Gastroparesis is a serious condition in which food takes too long to move through the stomach. It can result in pain and disability as well as poor nutrition. Those who suffer are usually treated with medication. But sometimes the medication does not work or can cause serious side effects.

One such treatment is metoclopramide, known in the U.S. by the brand name Reglan. While it can provide relief to some patients, long-term use of metoclopramide has been linked to a serious movement disorder known as Tardive Dyskinesia. Those who suffer from the condition have involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Medication wasn’t working for Munshi, but she found relief through the Internet in another from, a gastric pacemaker that is implanted in the stomach that shocks the stomach muscles to contract. After surgery, Munshi says doctors gave her tomato soup, but the patient felt so much better that when she got home she devoured her favorite dish – saag aloo. “Everything tastes great now and I haven’t been sick since,” she says.

Sources:
The Metro
The Sun

SOURCE: Reglan Side Effects › Pacemaker gives hope to sufferer of gastroparesis

The Gastroparesis, etc… blogger was diagnosed with the condition in 2004, and in that time has gathered a great deal of information on treatments for the debilitating condition, which she readily shares on her Web site. Gastroparesis is individualized and a treatment that works for one person may not work for another, she says.

She has tried a long list of treatments from Botox to acupuncture to Reglan, but few have worked well for her. She will receive a gastric neurostimulator, also known as a gastric pacemaker, next week. “It took four months to get the procedure approved by my insurance company, but in that time I gained a great deal of knowledge and collected a plethora of resources which I am anxious to pass along.”

The blogger also passes on to her readers information about new treatments and drug warnings, such as the recent black box warning on metoclopramide, also known by the brand name Reglan, and the newly approved Metozolv ODT, an orally disintegrating version of the same medicine. The black box warning notifies patients and health care workers of an increased risk of a serious movement disorder known as Tardive Dyskinesia associated with long term use of metoclopramide.

Whatever course of treatment sufferers of gastroparesis choose, the blogger offers this advice: “Be your own advocate. Truly, in every way. Do your own research. Try everything for yourself. And never, ever give up!”

SOURCE: Reglan Side Effects › Gastroparesis sufferer urges, Never give up!

Tranzyme Pharma’s

TZP-102 is an oral medication. Tranzyme’s equivalent medication, TZP-101, a drug given by IV in a hospital setting, has been put on hold by the company. While the drug showed promising results in phase II trials, the company hopes to buy time until the markets improve and the cost of capital drops.

Diabetic gastroparesis is a disorder in which the stomach takes too long to empty its contents. It affects people with both type 1 and type 2 diabetes. The condition is often treated with metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the FDA required manufacturers of metoclopramide to put a black box warning on the  medication warning health care providers and consumers of the risk of a serious involuntary movement disorder known as Tardive Dyskinesia.

Patients who suffer from Tardive Dyskinesia experience such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips and involuntary movements of the fingers. The condition is often irreversible even after medication has been stopped.

Analysts say a new treatment for diabetic gastroparesis would be welcome in an area where few treatments are currently available.

Source: Biz Journals

SOURCE: Reglan Side Effects › New treatment for gastroparesis granted FDA ‘fast-track’ status