But mothers need to be aware that the drug has serious side effects. KellyMom.com, a breastfeeding and parenting blogger, warns that one major side effect of Reglan is depression, a condition that tends to be more prevalent in new mothers. “It is contraindicated in moms with a history of depression, and all moms who take this should keep an eye out for signs of depression,” she writes. “It has caused serious depression/anxiety in moms regardless of previous history. This depression side effect usually develops over 3-4 weeks, and goes away if mom discontinues the Reglan.”

Laura, a lactation specialist, responded to the post in hopes of warning unsuspecting women of this possible side effect:

“First, you should know that I am a lactation consultant, I recently gave birth to my fourth child and despite my training and knowledge, I was in need of a galactogogue. I opted for Reglan upon consultation with my physician and despite a history of mild depression.

“After taking the medication for approximately 6 weeks, I decided it was time to taper off of the medication. Within 48 hours of my last dose, I began to suffer from severe anxiety and eventually even had one panic attack. I have never had any problems with, or history of anxiety or panic attacks in my life and as the result of an in-depth assessment by an anxiety disorder specialist, it was determined that this development was directly related to my use of Reglan.

“This experience was absolutely horrible! I was bed ridden for 10 days and it took a total of three weeks for me to recover completely. Subsequently, my milk supply suffered substantially from the physical insult. I have since, however, been able to recover it partially only after arduous pumping and retraining of my baby to take the breast once again.

“As a lactation consultant, I will be happy to educate my clients on the use of this drug, but I will never again recommend it myself.”

SOURCE: Reglan Side Effects › Women warn new mothers of Reglan’s depression risk

Harris’ lawsuit, on behalf of her minor child, claims the defendants “encouraged the long term use of these drugs, and concealed the drug’s dangerous side effects.” Last year, the Food and Drug Administration (FDA) ordered that a black box warning be placed on Reglan (metoclopramide) warning against long term use (greater than 12 weeks) of the drug because of the risk of Tardive Dyskinesia. Harris’ lawsuit claims the defendants were well aware of the drug’s serious side effects but failed to adequately warn users of the risk.

“Defendants breached these warranties (both express and implied) as the Reglan/metoclopramide was not merchantable, was unfit for its intended use and was unreasonably dangerous when comparing the benefits to the risks associated with its use,” the complaint states.

Harris’ lawsuit is filed against Pharmaceutical Associates, Beach Products, Morton Grove Pharmaceuticals, and Wockhardt. Harris is seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earning capacity, pre- and post-judgment interest and court costs.

SOURCE: Reglan Side Effects › Woman blames Reglan for causing her young child permanent disability

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 presentation, entitled, “Ulimorelin (ghrelin agonist) effects on daily vomiting due to diabetic gastroparesis,” summarizes the effects of ulimorelin in patients with daily, moderate to severe vomiting.

Individuals with severe gastroparesis face frequent hospitalizations and emergency room admissions due to recurrent nausea and vomiting, which are often associated with dehydration, malnutrition and weight loss due to inadequate caloric food intake. Currently, there are no safe and effective treatments for gastroparesis. Prescription medications to treat the condition were either withdrawn from the market or now carry a black box warning due to serious side effects.

For example, the gastroparesis drug Reglan (metoclopramide) has 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.

Tranzyme Pharma’s new drug, ulimorelin, offers a glimmer of hope to sufferers of severe gastroparesis. The Phase 2 study of diabetic patients with advanced gastroparesis given ulimorelin intravenously once daily for four days, demonstrated clinically and statistically significant improvements in multiple gastroparesis-related symptoms, including vomiting and nausea. Patients who had moderate to severe daily vomiting during the 4-day period just prior to the start of the study also reported a marked reduction in the number of days vomiting during the 4-day treatment period.

SOURCE: Reglan Side Effects › Experimental gastroparesis drug to be presented at medical conference

Drugs are available to curb the symptoms of acid reflux, even for the youngest infants. But they should be a last resort. Some of the medications routinely given to infants, such as Reglan (metoclopramide) can have serious side effects. Reglan has been associated with a number of drug interactions and can and may increase the risk of seizures in people who have seizures.

The first remedies to try should be natural ones. For example, finding relief for your little one may be as simple as changing the way your baby is fed. Decreasing volume and increasing the frequency of feedings can sometime remedy the problem. Bottle-fed babies can sometimes be given milk or formula thickened with a small amount rice cereal. Food allergies may also be the cause of reflux. The most common culprits are milk and soy proteins in formulas. Breast-feeding mothers should also take note of the foods they consume, as cow’s milk, soy, egg, and peanuts can cause their baby to experience reflux.

Because babies can’t adjust their position, parents should sit them upright when feeding and keep them upright after feeding. Placing a wedge – available at baby supply stores – under the baby’s mattress where the head goes also helps milk follow gravity and prevent reflux.

SOURCE: Reglan Side Effects › Infant reflux: Natural remedies should be tried before medical ones

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

However, it took more than a decade for the Food and Drug Administration (FDA) to place a black box warning on the medication, Reglan. A black box warning is the strongest warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. Meanwhile, the drug was dispensed 6.5 million times in 2008 to an estimated 2 million Americans.

Reglan, also known by the generic brand metoclopramide, is available in formulations including tablets, orally dissolving tablets, syrups and injections. It works by increasing muscle contractions in the upper digestive tract, which speeds up the rate at which the stomach empties into the intestines. But it also can lead to involuntary movements of the muscles, causing users to smack their lips, thrust their tongue, blink and bulge their eyes, jerk their heads, and purse their lips. Tardive Dyskinesia is debilitating and often symptoms don’t subside even after the medication has been discontinued.

So, why would it take the FDA so long to issue a warning about a medication with published reports of serious adverse events? Herb Denenberg with the Philadelphia newspaper The Bulletin, says delayed action by the government agency is not uncommon.

“This delayed warning of a drug’s danger is all too typical. It took (13) years for the FDA to sound this alarm put forth by Worst Pills, Best Pills News in 1996, thus needlessly exposing many millions to a serious side effect that might plague them for life, and might have been avoided if they were properly warned,” Denenberg argues. “I’d add to that warning. First, everyone should understand, as the Physicians’ Desk Reference explains, that side effects from the drug are unpredictable. The medication guide for Reglan states: ‘It is not possible for your doctor to know if you will get TD [Tardive Dyskinesia].’ So even short-term use may cause Tardive Dyskinesia. Second, the patient – not the doctor or the FDA – should decide whether the benefits of the drug are worth the risks of taking it. The patient should ask the doctor if there are other treatments, including other drugs that might be better options, or perhaps non-drug treatments that might be much safer.”

SOURCE: Reglan Side Effects › Why did FDA take so long to place black box warning on Reglan?

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