Most babies spit up a little. The technical term for this is Gastro-Esophageal Reflux (GER). The condition is common and affects most babies, usually without causing any pain. In some rare cases GER is less benign. If GER persists and is painful, it goes by the name of Gastro-Esophageal Reflux Disease (GERD). GERD can be so serious that it leads to erosion of the esophagus, reluctance to eat and resulting weight loss. The preferred treatments of infant GERD are non-medical remedies such as thickening of foods and making sure the baby stays upright after meals. If this doesn't help, pediatricians sometimes prescribe adult heartburn medications. Knowledge of how medication designed for adults affects children is incomplete. Caution is in order, as there are some horror stories involving certain GERD medications such as Propulsid (Cisapride). However Cisapride has been put on a limited-access program since July 2000 and is no longer marketed in the United States. Some pediatricians feel that medication is not usually necessary for treatment of GERD, most pediatricians advise judicious use of medication. There is also some debate on whether colic is sometimes confused with GERD and vice-versa.
MEDICATION CAN KILL: Salon "Kids as guinea pigs"
From "Kids as guinea pigs" by Dawn MacKeen
Gage Stevens fussed, cried and vomited often. Nothing his pediatrician recommended [...] worked. Finally, Gage's doctor told his mother about a specialist at Pittsburgh Children's Hospital who was testing the anti-heartburn drug Propulsid on children with Gage's condition. Maybe that would help, she recalls him saying. Six months later [...] he was dead.
The death of Gage Stevens, who suffered from a relatively common condition, gastroesophageal reflux disease (GERD), has reopened the issue of whether it is right to test powerful drugs on children. Should babies who can't even say "Mama," let alone decide to participate in a medical experiment, become pawns in the high-stakes game of drug research? Or is the death of a child simply the price that must be paid to determine if a drug is safe and effective for widespread use?
Most drugs are tested extensively on adults before the Food and Drug Administration approves them for general sale. Once a drug is on the market, a doctor may prescribe it for any patient, even a child. It is generally believed that only about one-fourth of medicines prescribed for children have been approved specifically for kids.
According to the family's lawyer, the second page of the "informed consent" document noted that there had been deaths as a result of taking this medication, but said most of those occurred when Propulsid was mixed with an antibiotic. In fact, Propulsid had been linked to at least 80 deaths and 341 heart rhythm abnormalities. Nineteen of the deaths were patients under 19 years old.
Most drugs prescribed for children have been tested on and approved for adults, but not kids. The medical community has pushed hard to change this. Drugs affect small, young bodies differently than grown ones. Doctors are allowed to prescribe medication for patients "off-label" — for purposes that have not specifically been approved. But many doctors say it is bad medicine simply to halve the dose of an adult drug and give it to a child. Inevitably, they say, kids will be put at risk. Either we limit and monitor the danger in a clinical trial, or experiment on the pediatric population at large through widespread off-label use.
In March, Jaansen Pharmaceutical pulled Propulsid off the market. Researchers are supposed to meet a high ethical bar in experimenting on children. With adults, a scientist may conduct a study that has tremendous risk and little therapeutic benefit, as long as the research is expected to yield valuable scientific information. Under federal regulations, children generally must benefit from participation in a study. If they don't, the study should pose minimal risk. In most cases, the experimental drug should be no more dangerous than other treatments for the child's condition.
MEDS USUALLY UNNECESSARY: Dr. Sears "GER: What it Is, What to Do FAQs"Symptomatic GER usually starts between two to four weeks of age, peaks around four months of age and begins to subside around seven months of age, when babies begin spending most of their days upright, start solid foods and by the law of gravity, food stays down easier. Most infants will outgrow GER by one year of age — I call this "walking away from GER." Yet, in some children, GER continues throughout childhood, and sometimes into adulthood, where it is manifested more by "heartburn" and "wheezing" episodes.
[...] Treatment for reflux is aimed at keeping baby comfortable and thriving and minimizing possible esophageal damage until the natural intestinal maturity enables baby to outgrow this condition.
The basis of GER treatment is:
1. Developing a feeding pattern and choosing foods that keep the stomach emptying rapidly and the food going down instead of up.
2. Positioning your infant — day and night — that allows gravity to help keep the food down.
3. Developing a parenting style that lessens crying, since crying increases intra-abdominal pressure, which worsens the reflux.
[...] Motility medicines. Work by increasing muscle tone and therefore tightening the lower esophageal sphincter muscle, or increase the movement of the muscle tone of the stomach and upper intestines, and thereby increase gastric emptying. They are sometimes referred to as prokinetics. The most common ones currently used in order of frequency are:
Urecholine (bethanechol). Side effects include cramping and diarrhea. This is the medication we most commonly use in our practice.
Reglan (metclopramide). Side effects include restlessness, twitching, and fainting. Because of the frequency of unpleasant side effects, we seldom use this medication in our pediatric practice.
Propulsid (cisapride) is a very effective prokinetic agent for increasing gastric emptying. Yet, because of the recently discovered side effects of cardiac arrhythmias, it is not used for reflux management without first performing an electrocardiogram.
Remember, while medications can certainly help ease the discomfort of GER and minimize esophageal damage, they should always be used in addition to, but not instead of most of the above parenting, positioning, and feeding suggestions. Be sure to work closely with your infant's doctor and/or a pediatric gastroenterologist toward working out a GER management regimen that works best and safest for your child.
MEDICATE IF NECESSARY: American Academy of Family Physicians "What You Should Know About Gastroesophageal Reflux (GER) in Infants and Children"GER is a common cause of "spitting up" formula or breast milk during the first year of life. Spitting up has been noted in 40 to 65 percent of healthy babies. By one year of age, only 1 percent of infants will spit up milk or solid foods. Most cases of GER will go away on their own. However, regular spitting up or vomiting in infants associated with any of the following symptoms may be a sign of a more serious problem:
? Weight loss or poor weight gain
? Frequent breathing problems such as not breathing for longer than 20 seconds, turning blue, choking, or unexplained wheezing, cough, or pneumonia
? Unexplained severe fussiness, crying, and discomfort with feedings
When GER does not go away after you make these changes, your doctor may want to give your child a medicine. A visit to a children's GI doctor may be needed.
Medicines that lower stomach acid include cimetidine (brand name: Tagamet), ranitidine (brand name: Zantac), omeprazole (brand name: Prilosec), and lansoprazole (brand name: Prevacid).
Other medicines include metoclopramide (brand name: Reglan) and cisapride (brand name: Propulsid). These help prevent return of food from the stomach to the mouth. You should know that extreme caution should be used if your child is given cisapride. Electrocardiogram (ECG) tests should be done. Certain medicines should not be taken while taking metoclopramide and cisapride. You should carefully check to make sure you are giving the proper dosage. Your doctor can help if you have any questions.
MEDICATE IF NECESSARY: Babies Today — iParenting "Tummy Trouble? A Guide to Your Newborn's Digestive System"When one swallows food, it travels down a path through the esophagus and into the lower esophageal sphincter. In most newborn babies, this sphincter is immature, making spitting up a common occurrence. Gastroesophageal reflux (GER) usually occurs during or after a feeding when the stomach contents regurgitate into the esophagus.
"More than half of all babies experience reflux in the first three months of life, and most infants stop spitting up between 12 months to 18 months of age," Dr. Hochman says. According to Dr. Sacks, GER can be toned down through changes in feeding techniques, changes in infant positioning, changes in the infant formula or thickening the formula with rice cereal.
Gastroesophageal reflux may develop into a more severe condition called gastroesophageal reflux disease (GERD). Signs and symptoms of GERD include weight loss, breathing problems, feeding problems and spitting up blood. In these cases, Dr. Sacks says that acid suppression medications should be prescribed and are usually well tolerated. He says surgery is rarely needed.
MEDS ARE SAFE: Pediatric Adolescent Gastroesophageal Reflux Association "Are the Medicins Safe for my Baby?"Are the medicines safe for my baby? This is one of the most common questions we are asked. Fortunately, it appears as though most medications used to treat GER are reasonably safe. An equally important question may be "What are the long term effects of not medicating a child with significant reflux?"
When you are making decisions about safety, you should consider that not treating reflux may be the more dangerous course of action.
At PAGER, we are almost more concerned that scientists will learn in the future that there are some health issues that arise from a chronic lack of acid. But at the moment, we don't really have any other options and it isn't fair to let a child suffer in excruciating pain in the hopes that some better options will come along. Medicine is a constantly evolving science. What we think we know now may be laughable in a decade. But your child's life may be intolerable without medications. You have to make the best decisions you can with the information that is available NOW.
On a positive note, a few of the GER medications have recently been tested in children. Many other pharmaceutical companies are also working towards getting their pediatric approval from the FDA which is good news for everybody.