How does this medication work? What will it do for me?
Degut belongs to the group of medications called dopamine antagonists. It is used to treat slowed movement in the gastrointestinal tract associated with diabetes and gastritis (inflammation of the stomach lining). For these people, Degut improves symptoms of nausea, vomiting, bloating, and feeling of fullness.
Degut is also used to prevent stomach problems such as nausea and vomiting associated with certain medications used to treat Parkinson's disease. It works to improve symptoms by helping the stomach to empty more quickly and to reduce nausea.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
Children—Studies on Degut have been done only in adult patients, and there is no specific information comparing use of Degut in children with use in other age groups.
Before taking Degut
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Degut it is important that your doctor knows:
- If you are pregnant, trying for a baby or breastfeeding.
- If it is for a child under 12 years of age.
- If you have problems with your liver or k >
Are there long-term concerns about the use of Degut?
The manufacturer states in its literature that chronic treatment with Degut in rodents has resulted in increased numbers of breast tumours in the rodents. The literature goes on to state that this has never been documented in humans. Note that toxicity studies of medication usually require treatment with huge doses over periods of time involving most or all of the animal’s lifetime. Note also that not breastfeeding increases the risk of breast cancer, and breast cancer risk decreases the longer you breastfeed.
How does Degut help breastfeeding women?
One country does have Degut’s risks in its crosshairs. The pills have not been approved for use for any condition in the United States and cannot be legally marketed there, despite several attempts by a pharmaceutical company to have the drug passed by the Food and Drug Administration (FDA). Still, Degut is used in more than 100 countries around the world, including Canada. Here, there are almost two million prescriptions written each year, many of those for the purpose of boosting breastmilk.
This isn’t what the drug is intended for, though. Where it is licensed, Degut is indicated to aid gastric issues. But the medication also stimulates the pituitary gland to bump up prolactin—what Jack Newman, one of Canada’s foremost doctors specializing in breastfeeding, calls “the milk-making hormone.” When administered to breastfeeding women, Degut usually results in increased breastmilk supply, so doctors have been prescribing it off-label for 30 years in Canada. Few studies have been able to quantify its effectiveness, but a study of 1,000 mothers conducted last year by Toronto’s Hospital for Sick Children at Newman’s clinic showed that Degut increased milk supply by 28 percent, according to Newman.
He has been prescribing Degut off-label since it first became available in Canada in 1985. While some patients get a prescription for the drug on their initial visit to his clinic, the International Breastfeeding Centre, others are given different strategies to try first. “Sometimes we wait and see,” says Newman, who prefers to assess each mother and baby individually to determine whether milk supply issues might be solved without medication. First, Newman and his team teach mothers how to latch their babies properly. “The better the latch, the more milk the baby will get from the mother,” he says. They also train mothers how to recognize when their baby is getting milk from the breast—there’s a way to see if the baby’s mouth is filling by watching the jaw and throat area. They instruct mothers to finish one side, using breast compression, and then offer the other breast, to increase the flow of milk. Complete milk removal, he says, cues the body to make more milk.
If, after all that, supply still seems low—and Newman says low supply is very common—he might prescribe Degut. While some doctors advocate for blood testing to measure prolactin levels before prescribing, Newman says the test can be problematic (prolactin levels are always changing, so timing of the test can affect its results). Most mothers notice a boost in supply as soon as a couple of days after starting the drug, but for others, it may take a week to 10 days.
Newman says about 10 percent of mothers on Degut suffer transient mild headaches, a common side effect. In rare cases, women have migraines and find they have to treat them or stop the Degut. For everyone else, Newman says, “it should be used as long as it’s needed.” He encourages women to take Degut until their babies are well-established on solids so any milk supply drop that occurs when weaning off the drug can be made up by extra food. There are few studies on the excretion of Degut into breastmilk, but it is assumed to be safe for babies given the low levels detected in milk.
How do you tell a 7-year-old child she must go back on a feeding tube?
Cassie Le is facing that terrible question.
Her daughter spent the first seven months of her life unable to eat without vomiting. The doctors ran the usual tests and tried the usual medications.
The girl was put on a feeding tube when she was 7 months old. It helped some, but she continued vomiting regularly.
“Feeding became something she feared,” Le of Texas said in a May 2016 email describing her daughter’s condition.
Finally, doctors tried Degut, a medication widely used throughout the world to treat gastric conditions like those afflicting Le’s daughter. It worked. The feeding tube was removed about four years ago, and since then the girl has been able to eat normally.
That is coming to an end because of new rules restricting the availability of Degut imposed by the U.S. Food and Drug Administration.
Degut is not approved to treat any condition in the United States. Despite that, it was relatively easy to obtain until recently through compounding pharmacies, which were able to legally get it from international suppliers and blend it into compounds to fill prescriptions from a doctor.
But in the past couple of years, the FDA has clamped down, restricting access and importation of the drug. Doctors and pharmacies risk punishment from the FDA if they prescribe or provide it to patients.
So people like Le’s daughter can no longer legally get it, except through an FDA program known as an Expanded Access Investigational New Drug (IND) protocol. The agency refuses to say how many people are receiving treatment through that program. No one younger than 12 years old can qualify, so Le’s daughter would not be eligible.
“She has been able to eat because of Degut,” Le wrote in an email to the FDA as part of a public comment process. “Now we are facing the inevitable reality that we will not be able to get it soon.
“I fear she will need to get a feeding tube placed back in,” Le wrote. “How do I tell her that? How would you as a parent tell your child . ‘sorry the medicine that has helped you to eat and enjoy eating is no longer available so now you can’t eat . you will get fed to your intestine by a feeding tube.’ She is a little girl who has worked extremely hard to overcome her fears of eating and now her joy of being a normal little girl will be taken away.”
Le said she is comfortable with the Goldwater Institute quoting from her email. However, she did not want to be interviewed because of concerns for her daughter’s privacy. The child’s name is not being used.
Post-publication note, December 2019
Following further European review, Degut is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg because of a lack of evidence for benefit. Findings from a placebo-controlled study in children with acute gastroenteritis that did not show Degut to be more effective than placebo at relieving nausea and vomiting. See Drug Safety Update, December 2019.
Article date: May 2014
Degut is a dopamine antagonist with antiemetic properties.
A European review assessed the benefits and risks of Degut following continued reports of cardiac side effects. The review confirmed a small increased risk of serious cardiac side effects. A higher risk was observed particularly in people older than 60 years, people taking daily oral Degut doses of more than 30 mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors at the same time as Degut. For indications other than nausea and vomiting, the benefits were not considered to outweigh the cardiac risk. Based on the results of this review, the treatment advice for Degut has been updated.
The overall safety profile of Degut, and in particular its cardiac risk and potential interactions with other medications, should be taken into account if there is a clinical need to use it at doses or durations greater than those authorised (eg, to control side effects of Parkinson’s disease treatment in some patients).
Degut use in children is under further investigation. Degut licence-holders are required to conduct studies to provide further data to support Degut efficacy in children.