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

Salix Pharmaceuticals

Salix hopes to gain full FDA approval to market Metozolv as a short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal reflux (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, or delayed emptying of the stomach. Salix currently has 96 salespeople and wants to hire and additional 64 people to its sales force this year to help push the new product.

Drugs for such gastrointestinal ailments as gastroparesis are few and far between and not without their issues. It remains to be seen if when Metozolv hits the market, it will carry the same black box warning already on Reglan, an oral tablet form of metoclopramide that is swallowed. The boxed warning came after it was revealed that long-term use of the drug was linked to a serious involuntary movement disorder known as Tardive Dyskinesia. There is no known cure for the condition, and symptoms may persist even after the medication has been discontinued.

Source: The News & Observer

SOURCE: Reglan Side Effects › Salix plans to increase sales force to push new gastroparesis drug

Earlier this year the FDA ordered all makers of metoclopramide to provide a risk evaluation and mitigation strategy (REMS) following reports linking the drug to a serious condition in which a person develops involuntary movements of his muscles known as Tardive Dyskinesia. Those taking the medication for more than 12 weeks, elderly patients, and women are at an increased risk of developing the severe adverse reaction. There is no know cure for Tardive Dyskinesia and symptoms may persist even after the medication has been discontinued.

As a result of the REMS, the FDA elevated the warnings to a boxed warning on package inserts of metoclopramide warning of the risks associated with long-term use. Metoclopramide is perhaps most known in the U.S. by the brand name Reglan. An estimated 2 million American use some form of metoclopramide.

Source: Seeking Alpha

SOURCE: Reglan Side Effects › Salix metoclopramide drug moves closer to FDA approval

While uncomfortable, both heartburn and GER are experienced at least weekly by some 20 percent of Americans. When GER symptoms occur more than twice a week, it is considered to be the more seriuos gastroesophageal reflux disease (GERD). GERD, which affects people of all ages, can eventually lead to more serious health problems.

Conditions such as a hiatal hernia or factors such as obesity, pregnancy and smoking can contribute to GERD. Foods can aggravate the condition, such as citrus fruits, chocolate, drinks with caffeine or alcohol, fatty and fried foods, garlic and onions, mint flavorings, spi8cy foods and tomato-based foods like spaghetti sauce, salsa, chili and pizza.

GERD and GER are often treated through lifestyle changes such as avoiding food triggers, losing weight, and not lying down for three hours after a meal. Medications can also be recommended or prescribed, such as antacids, foaming agents such as Gaviscon, H2blockers such as Tagament HB and Pepcid AC, proton pump inhibitors such as prilosec and Nexium, and prokinetics, such metoclopramide, known by the brand name Reglan.

Patients should discuss with their doctors which medication would work best for their condition. Some medications, such as Reglan (metoclopramide) have side effects such as fatigue, sleepiness, depression and anxiety that limit their usefulness. Reglan also has been linked to a serious physical condition known as Tardive Dyskinesia, which causes a person to develop jerking movements of their muscles in their bodies, in particular in their face and fingers. As always, any adverse reactions experienced while taking medication should be reported to your doctor.

Source: National Digestive Diseases Information Clearinghouse (NDDIC)

SOURCE: Reglan Side Effects › Heartburn, GER, GERD treatments should be discussed with doctor