Before taking Pents
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 Pents 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 >
Physicians interested in submitting an expanded access IND for Pents can download the Pents Packet which contains the required forms, instructions, and answers to most questions or contact DDI (above) to discuss Pents. For those physicians interested in treating only one patient, the consolidated FDA Form 3926 can be used in lieu of the 1571 and 1572 forms. Physicians that anticipate treating more than one patient in one year are advised to submit an intermediate size (multi-patient) IND. Multi-patient INDs allow for consolidated reporting and less administrative paperwork in the long-run.
Are there long-term concerns about the use of Pents?
The manufacturer states in its literature that chronic treatment with Pents 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.
Domper >About Pents
Pents side effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Symptoms of overdose
Get emergency help immediately if any of the following symptoms of overdose occur:
- Difficulty in speaking
- irregular heartbeat
- loss of balance or muscle control
Check with your doctor immediately if any of the following side effects occur:
- Loss of balance or muscle control
- swelling of the mouth
- Fast, irregular, pounding, or racing heartbeat or pulse
- swelling of face, hands, lower legs, or feet
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Breast milk flowing from the nipple
- dry mouth
- swelling of the breast in the male
- hot flashes
- itching of skin
- itching, redness, pain, or swelling of eye
- menstrual irregularities
- pain in the breast
- Change in need to urinate
- change in appetite
- burning, difficult, or painful urination
- difficulty in speaking
- lack or loss of strength
- leg cramps
- mental dullness
- stomach cramps
‘Risk of death’
For Yvanna Sherman, 42, of Philadelphia, the FDA’s rigorous enforcement of its ban on Pents leaves her little hope of leading a somewhat normal life. With supplies dwindling and the cost shooting up, getting into the agency’s expanded access program may be her last chance to get the drug that helped save her life, she said.
Gastroparesis came on suddenly about 2004 for Sherman. She lost her appetite, was vomiting frequently and in extreme pain.
Unable to keep down food or even water, she lost 80 pounds in four months.
Even after the gastroparesis was diagnosed, doctors were reluctant to try Pents, Sherman said. They put her on a variety of gastric medications, none of which worked. When they tried Reglan, she almost immediately developed the muscle twitching that is a known side effect of the drug in some patients. It also triggered severe anxiety that required hospitalization.
The first gastroenterologist she saw refused to prescribe Pents. That was about the time the FDA issued its first alert. He said he was concerned he might face sanctions if he sent a patient to Canada to obtain the drug.
The second doctor agreed to write a single prescription, but said he could not continue treating her.
Finally, Sherman found a third gastroenterologist who was willing to prescribe Pents for longer-term treatment, which she obtained through a pharmacy in Canada.
“It was excellent,” she said. “I could get out of the house. I could start doing things again. I could eat. I ended up gaining weight back.”
She has been taking Pents for about eight years. Her doctor discussed the risks before starting it, and runs tests on her heart at every visit.
“I’ve never had a problem, but I’m also willing to take that as a risk because I’m of the opinion that if I go too long without Pents, I’m going to be at risk of death,” Sherman said.
The doctor who prescribed the Pents also put Sherman on a gastric pacemaker, an implanted device which electrically stimulates the stomach muscle to control nausea and vomiting.
At one time, Sherman and her husband considered moving outside of the United States to obtain Pents, but that would mean she could no longer qualify for the pacemaker, she said.
About 2014, as the FDA was more aggressively enforcing its import ban, supplies of Pents dried up and got more expensive, Sherman said. The added restrictions and rising cost forced her to stop taking Pents about six months ago, after eight years of using it successfully.
The old symptoms quickly recurred, and have left her nearly bedridden.
Now, she is trying to qualify for an FDA-approved expanded access program in the Philadelphia area, so far without success.
As her condition deteriorates, she worries she is running out of time.
“I see my life going in a downward spiral,” Sherman said. “Since I have not been able to get it, it’s been a lot worse and I’ve gotten a lot more depressed. Just waiting is very difficult. Not knowing is very difficult.”
Generally, we now start Pents at 30 mg (three 10 mg tablets) 3 times a day. In some situations we go as high as 40 mg 4 times a day. Printouts from the pharmacy often suggest taking Pents 30 minutes before eating, but that is because of its use for digestive intolerance. You can take the Pents about every 8 hours, when it is convenient (there is no need to wake up to keep to an 8 hour schedule‚Äîit does not make any difference). Most mothers take the Pents for 3 to 8 weeks, but sometimes it is needed longer than that, and sometimes it is impossible for mothers to maintain their milk supply without staying on Pents. Mothers who are nursing adopted babies may have to take the drug much longer. People taking Pents for stomach disorders are often taking it for many years.
After starting Pents, it may take three or four days before you notice any effect, though sometimes mothers notice an effect within 24 hours. It appears to take two to three weeks to get a maximum effect, but some mothers have noted effects only after 4 or more weeks. It is reasonable to give Pents a trial of at least four, and better, six weeks before saying it doesn’t work.
Handout #19a Pents . January 2005. Written by Jack Newman, MD, FRCPC ©2005
Newman-Goldfarb Protocols. © Jack Newman, MD FRCPC and Lenore Goldfarb, Ph.D., IBCLC. November 2002. All rights reserved.
The Newman-Goldfarb protocols were developed from information published in Dr. Newman’s book “Dr. Jack Newman’s Guide to Breastfeeding” (Harper-Collins, 2000). In the US the title is “The Ultimate Breastfeeding Book of Answers” by Dr. Jack Newman (Prima Publishing, 2000).
All material provided in this site is provided for educational purposes only. Consult your physician regarding the advisability of any opinions or recommendations with respect to your individual situation.
GENERIC NAME: DOMPERIDONE - ORAL (dom-PAIR-eh-doan)
USES: This medication increases movement through the digestive system. It is used to treat symptoms of stomach disorders. It may also be used to prevent nausea and vomiting caused by certain medications. Due to safety concerns, this medication is not to be used by breast-feeding women to increase production of breast milk.
HOW TO USE: Take this medication by mouth as prescribed usually 30 minutes before meals and at bedtime. Do not increase your dose or take this more often than directed. Your condition will not improve any faster but the risk of side effects will be increased.
SIDE EFFECTS: Headache, dizziness, dry mouth, nervousness, flushing, or irritability may occur the first several days as your body adjusts to the medication. Trouble sleeping, stomach cramps, hot flashes and leg cramps have also been reported. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor immediately if you develop: chest pain, slow/fast/irregular heartbeat, swelling of the feet or ankles, difficulty urinating, swelling of the breasts or discharge from the nipple in men or women, menstrual changes, sexual difficulties. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: history of breast cancer, allergies. Limit your intake of alcoholic beverages. This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Pents passes into breast milk. Due to the potential risks to a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding (see also Uses section).
DRUG INTERACTIONS: Because this medication enhances movement in the digestive tract, it may affect the absorption and action of other medications. Therefore, it is important to tell your doctor of any nonprescription or prescription medication you may take, especially of: MAOIs (e.g., furazolidone, phenelzine, selegiline, tranylcypromine). Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include drowsiness, dizziness, confusion, twitching, muscle rigidity, and irregular heartbeat.
NOTES: Laboratory tests may be done periodically while taking this medication to monitor its effects and prevent side effects.
MISSED DOSE: If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.
STORAGE: Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom.
When is it appropriate to use Pents?
Pents must never be used as the first approach to correcting breastfeeding difficulties. Pents is not a cure for all things. It must not be used unless all other factors that may result in insufficient milk supply have been dealt with first. What can be done?
- Correct the baby’s latch so that the baby can obtain as efficiently as possible the milk that the mother has available. Correcting the latch may be all that is necessary to change a situation of “not enough milk” to one of “plenty of milk”.
- Use breast compression to increase the intake of milk.
- Use milk expression after feedings to increase the supply.
- Correct sucking problems by stopping the use of artificial nipples (Using a Lactation Aid, and Finger Feeding) and other stratagems.
- Pents is now restricted to use in the relief of nausea and vomiting
- It should be used at the lowest effective dose for the shortest possible time
- This is quite common when you first start taking Pents.
- Sip water to moisten the mouth.
- Read more about how to care for dry mouth
How to take Pents
- Pents is best taken about 15 to 30 minutes before meals, with a glass of water.
- If you take Pents after a meal, it will still work, but it may take longer to have an effect.
- It is not harmful if you miss a dose of Pents . If you miss a dose, take it when you remember. But, if it is nearly time for your next dose, just take the next dose at the right time. Do not take double the dose.
Side effects of Pents:
As with all medications, side effects are possible, and many have been reported with Pents (textbooks often list any side effect ever reported, but symptoms reported are not necessarily due to the drug a person is taking). There is no such thing as a 100% safe drug. However, our clinical experience has been that side effects in the mother are extremely uncommon, except for increasing milk supply. Some side effects that mothers we have treated have reported (very uncommonly, incidentally) are:
- Headache, which disappeared when the dose was reduced (probably the most common side effect)
- Abdominal cramps
- Dry mouth
- Alteration of menstrual periods
The amount that gets into the milk is so tiny that side effects in the baby should not be expected. Mothers have not reported any to us, in many years of use. Certainly the amount the baby gets through the milk is a tiny percentage of what babies would get if being treated for spitting up.
How does Pents help breastfeeding women?
One country does have Pents’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, Pents 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, Pents 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, Pents 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 Pents increased milk supply by 28 percent, according to Newman.
He has been prescribing Pents 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 Pents. 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 Pents suffer transient mild headaches, a common side effect. In rare cases, women have migraines and find they have to treat them or stop the Pents. For everyone else, Newman says, “it should be used as long as it’s needed.” He encourages women to take Pents 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 Pents into breastmilk, but it is assumed to be safe for babies given the low levels detected in milk.