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Inexium: when and why should an infant be given this medicine?
Inexium is a drug commonly prescribed for gastroesophageal reflux disease (GERD) in adults, adolescents, but also in children or even infants. Sometimes given over long periods of time, this treatment would not always be prescribed in accordance with official recommendations.
according to Prescribe, independent medical journal published by the Association Mieux Prescrire, proton pump inhibitors (PPIs) such as Inexium would be strongly prescribed in France, and their use would not always be well suited. The doses prescribed would sometimes be higher than the officially recommended doses, and one in five patients would receive long-term treatment, which is not without risk.
We asked for the insight and opinion of Prof. Frédéric Gottrand, pediatrician at Lille University Hospital, in the Gastroenterology and Pediatric Nutrition department.
Pathological or physiological GERD: the importance of distinguishing the two
Gastroesophageal reflux disease (GERD) is defined as a rise of gastric contents to the esophagus, in an externalized way or not (we then speak of internal reflux). It is most often manifested by of the regurgitation effortlessly, without retching (unlike vomiting).
In infants, in the vast majority of cases, this reflux is physiological. “It is estimated that 60 to 70% of 6-month-old babies regurgitate once a day, or even 3 times a day for 40 to 50% of them”, says Professor Gottrand.
Baby’s gastroesophageal reflux disease is considered pathological when it is a source of complications, that is to say when a esophagitis (inflammation of the lining of the esophagus) is visible endoscopically, when it causes a break in the weight curve, or symptoms that are bothersome for the child (sleep disturbances, refusal to eat, possible traces of blood in the regurgitation, and crying). And this is the whole difficulty: if a child will be able to describe his discomfort, a baby who does not speak will express it by crying. Crying which may be due to many other things elsewhere.
“According to several studies carried out on this subject, less than 5% of the baby’s crying is related to reflux », says Professor Gottrand. In 95% of cases, it is therefore something else.
A treatment to be tested with an appropriate dosage and dosage
Inexium is a drug from the proton pump inhibitor family. It binds to this pump, which is then destroyed. Results : the production of acid decreases in the stomach. Inxium works by reducing acid secretions in the stomach. ” It treats the acidic side of regurgitation, but not the regurgitation itself ”, explains Professor Gottrand, who specifies that there is no treatment available in France to overcome reflux itself in infants.
If the Inexium does have a marketing authorization (AMM) against GERD, this is reserved for babies over one year old. However, if the efficacy of Inexium has not been scientifically demonstrated in infant GERD, this drug has good tolerance in 0-1 year olds.
However, international recommendations are in favor of a prescription of Inexium (or other PPI) if and only if esophagitis has been confirmed by endoscopy. As this examination can be difficult and aggressive in the baby, Prof. Gottrand believes thata therapeutic test may be acceptable. In other words, Inexium prescribed for a short time, without increasing the dose, and stopped if no improvement is visible after one week.
“If there is no response to treatment after a week, it is not worth continuing or increasing the dose”, insists the pediatrician. ” If the baby continues to cry, look for other causes (anxious baby, teething…) », he adds. Same thing if one suspects an allergy to the proteins of cow’s milk (APLV), underlines the pediatrician: a test of eviction of one week is enough.
Professor Gottrand deplores, like the review Prescribe, over-prescription of Inexium or misuse of this medication. A majority of babies on Inexium are said to be outside of the recommendations and good practices (unsuitable doses, excessively long treatment, etc.).
An over-prescription that the pediatrician explains in particular by the time taken for detailed explanations and advice to overcome reflux without medication – time that doctors cannot always take – and by the parents’ desire to have immediate answers and turnkey solutions to relieve their babies.
GERD: how to relieve baby without medication?
Before choosing a reflux medication, if it is a priori physiological, benign, without complications, there is everything a lot of healthy and dietary advice to establish. Knowing that these hard times are which will disappear over time, with the acquisition of the sitting position, the four legs then the walk.
Often, babies with simple GERD are hungry, and then eat too much or too quickly during their meal, which results in a too full stomach, and, ultimately, a reflux, explains Professor Gottrand. Take time to eat, calmly, split meals, or adapt the flow rate of the teat bottle feeding may be solutions.
If the baby is breastfed, getting the services of a lactation consultant can be of great help. We can then adapt them breastfeeding positions, apply tips to reduce the flow of milk coming out of the breast … There are many things to try before stopping breastfeeding, or expressing breast milk to thicken it.
We can also adapt supplementation, by reducing or increasing the volume of flour and cereals added to infant milk, thicken the milk with specific products, or even introducing a solid diet, since food diversification can begin between 4 and 6 months. It is also advisable not to over tighten the baby’s diapers to avoid compressing the abdomen.
Positional measures can also be useful, such as keeping the infant in a semi-seated position for 30 to 45 minutes after a meal.
Infant GERD: What Are the Side Effects of Inexium?
If it is better to first undertake to treat simple GERD with hygienic and dietary measures, it is because Inexium is not such a harmless treatment, even if well tolerated in toddlers.
Short term, the Inexium (and other PPIs) did not no major side effects, apart from rare gastrointestinal concerns (vomiting, diarrhea, abdominal pain).
Long-term on the other hand, when prescribed over several months, Annexium has two effects demonstrated :
- an increase in respiratory infections (pneumonia),
- an increase in infectious diarrhea (due in particular to the bacteria Clostridium difficile).
These two phenomena can be explained by the drop in the acidity of the stomach: the stomach barrier no longer does its job, and bacteria that used to be destroyed are no longer. The intestinal flora is also altered, which can be harmful in the long term.
Other side effects are suspected, without having been clearly proven, such as a problem of calcium absorption, ultimately leading to osteoporosis (with in particular a greater risk of hip fracture in adults), a decrease in absorption of vitamin B12, and a greater risk of food allergies.
On its website, the review Prescribe indicates that “a Prolonged taking of PPI exposes you to many undesirable effects which are sometimes serious, such as: bacterial, digestive or pulmonary infections; bone fractures, muscle and joint pain; decrease in sodium, magnesium and calcium in the blood; kidney damage; increased mortality “.
Finally, in the event of prolonged intake and / or increased doses, there is a risk of rebound effect (see paragraph below on weaning).
Polysilane or Gaviscon, interesting alternatives
In the therapeutic arsenal available to treat GERD in infants, we find in particular Gaviscon ® and Polysilane Gel. These two drugs work as a gastric dressings, with symptomatic action and local efficacy. Which is more supported for Gaviscon than for Polysilane, for which the evidence of effectiveness is more limited.
Note that these two drugs have a priori fewer long-term side effects than Inexium, since they only act local antacids. They relieve the baby who is embarrassed by the acidity of his regurgitation, without modifying the acidity of his stomach.
Inexium and withdrawal: what precautions when stopping?
Because proton pump inhibitors (PPIs) decrease the production of stomach acid, the body reacts by increasing the secretion of gastrin, which stimulates the production of acids. ” In children and adults on Inexium, we can find gastrinemia (gastrin level in the blood, editor’s note) a little above the norms ”, details Professor Gottrand.
Also, when Inexium has been given for a long time (several months) and / or in large doses, and it is suddenly stopped, We can see transient hyperacidity for a few weeks. A rebound effect which can unfortunately encourage the resumption of treatment. We can then stop by gradually reducing the doses, and why not by giving a little Gaviscon instead.
Same story on the side of the review Prescribe : “After a few weeks of treatment, stopping a PPI exposes you to a rebound in gastric acidity, a source of acid regurgitation and digestive burns which encourage resumption of treatment. When stopping the PPI, the use of an antacid (aka “gastric bandage”) should therefore be considered in order to pass the period at risk of rebound gastric acidity. An antacid can also prevent you from simply starting PPI treatment. “
For Professor Gottrand, the risks of long-term treatment with Inexium (or other PPI) – apart from a few specific situations, such as certain malformations of the esophagus, cystic fibrosis or multiple disabilities – are not “Not acceptable even if they are not major or dramatic”.