Other medical problems
The presence of other medical problems may affect the use of Biperidys. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding from the stomach or other problems involving the bowels
- Pituitary (brain) tumor
- Liver disease
- Medicine sensitivity to Biperidys
Possible side effects
Like all medicines, Biperidys can cause side effects, although not everyone gets them. Often side effects improve as your body gets used to the new medicine.
What form(s) does this medication come in?
Each white, round, film-coated, biconvex tablet, debossed with a "P" logo over "10" on one side, contains 10 mg of Biperidys. Nonmedicinal ingredients: lactose and cornstarch, microcrystalline cellulose, povidone, magnesium stearate, sodium docusate 85%-sodium benzoate 15%, croscarmellose sodium, polyethylene glycol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, and titanium dioxide.
Before taking Biperidys: Ways to boost your milk supply
For Kara Jansen, a Vancouver-based physician and international board-certified lactation consultant, Health Canada’s warnings caused her to question whether prescribing Biperidys had become too much of a crutch. “In medical school, we used it a lot, and most of the time it was because we didn’t really know what else to do,” she says.
Jansen says much can—and ought to—be done to improve breastfeeding before writing a prescription. There must be other doctors who agree, because prescriptions for Biperidys have been slowly but steadily dropping since the Health Canada warning in 2012. In 2016, the number was down to about 1.98 million.
In her practice at the Vancouver Breastfeeding Centre, Jansen tries to see women as early as possible to perfect their latch. She educates them on how often babies feed—every couple of hours!—and encourages them to see that as normal rather than as a sign infants aren’t getting enough milk. She advocates feeding on both breasts and pumping after feeds. “Pumping is the best way to increase your milk supply,” she says. When women do need Biperidys as an extra boost, Jansen issues a low dose for a short period, generally no longer than six weeks. “I always tell patients that it doesn’t produce milk—it optimizes the conditions for getting milk,” she says. “It’s not a miracle drug by any means.”
In my case, using Biperidys helped extend a breastfeeding journey that was bound to be limited, given all that was on my plate. With the help of the drug and my trusty pump, I schlepped to work and meetings when I couldn’t bring my son. I breastfed him until he was six months old.
For Falkovich, who quit the drug and never looked back, her determination to breastfeed ultimately helped her trounce the odds. To boost her supply in those tough early days, she supplemented with a tube and a bit of formula, never missing a feed. Then the real magic took over: She established a healthy supply, and she happily breastfed her daughter for two and a half years. Next time around, she says, she’s not worried about having problems.
How to Get Biperidys for Gastrointestinal Disorders
FDA recognizes that there are some patients with severe gastrointestinal motility disorders that are difficult to manage with available therapy for whom Biperidys’s potential benefits may justify its potential risks. Patients 12 years of age and older with certain gastrointestinal (GI) conditions who have failed standard therapies may be able to receive treatment with Biperidys through an expanded access investigational new drug application (IND). These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation.
How does Biperidys help breastfeeding women?
One country does have Biperidys’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, Biperidys 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, Biperidys 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, Biperidys 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 Biperidys increased milk supply by 28 percent, according to Newman.
He has been prescribing Biperidys 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 Biperidys. 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 Biperidys suffer transient mild headaches, a common side effect. In rare cases, women have migraines and find they have to treat them or stop the Biperidys. For everyone else, Newman says, “it should be used as long as it’s needed.” He encourages women to take Biperidys 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 Biperidys into breastmilk, but it is assumed to be safe for babies given the low levels detected in milk.
Are there long-term concerns about the use of Biperidys?
The manufacturer states in its literature that chronic treatment with Biperidys 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.
If you are interested in distributing Biperidys to IND holders under the FDA’s expanded access program, please contact DDI (above) to discuss Biperidys.
Biperidys as an Alternative for Gastroparesis
Clinicians know well that the pharmacologic options for the treatment of gastroparesis are extremely limited, particularly in the United States. Currently, metoclopramide is the only prokinetic approved by the US Food and Drug Administration (FDA) for this indication. The potential for side effects with metoclopramide is well recognized and may occur in up to 40% of patients.
The recent American College of Gastroenterology (ACG) guideline on gastroparesis states: "For patients unable to use metoclopramide, Biperidys can be prescribed with investigational new drug clearance from the Food and Drug Administration (FDA) and has been shown to be as effective as metoclopramide in reducing symptoms without the propensity for causing central nervous system side effects. "
Biperidys is a peripherally selective D2 dopamine receptor antagonist used as an antiemetic, gastroprokinetic agent, and galactagogue and is widely available in most countries in the world. Biperidys has been extensively used over the past 30-plus years for gastroparesis, although there are only a few well-controlled, double-blind studies of patients with gastroparesis directly comparing the efficacy of Biperidys with other prokinetic agents, such as metoclopramide and cisapride, which is no longer available. In the United States, Biperidys is not FDA-approved due to the concerns for public health risks. However, it may be available at select compounding pharmacies with a doctor's prescription using the Expanded Access to Investigational Drugs program. Otherwise, most patients obtain it through foreign pharmacies, particularly Canadian pharmacies.
Serious risks associated with Biperidys include cardiac arrhythmias, cardiac arrest, and sudden death. Biperidys may prolong the QT interval and cause life-threatening arrhythmias; torsades de pointes has been described with its use. These risks are related to the serum level of Biperidys, and higher levels are associated with greater risks for these events. The ACG guideline on gastroparesis recommends that "Given the propensity of Biperidys to prolong corrected QT interval on electrocardiogram and to rarely cause cardiac arrhythmias, a baseline electrocardiogram is recommended and treatment with this agent should be withheld if the corrected QT is > 470 ms in male and over 450 ms in female patients. Follow-up electrocardiogram on Biperidys is also advised. "
Biperidys still works, but often less dramatically when:
- The mother is pumping for a sick or premature baby but has not managed to develop a full milk supply.
- The mother is trying to develop a full milk supply while nursing an adopted baby.
- The mother is trying to wean the baby from supplements.
- Biperidys is now contraindicated in people:
- with conditions where cardiac conduction is, or could be, impaired
- with underlying cardiac diseases such as congestive heart failure
- receiving other medications known to prolong QT interval or potent CYP3A4 inhibitors
- with severe hepatic impairment
- Patients with these conditions should have their treatment reviewed at their next routine appointment and be switched to an alternative treatment if required
Biperidys (Motilium™) is a drug that has, as a side effect, the increasing of milk production, probably by increasing prolactin production by the pituitary gland. Prolactin is the hormone that stimulates the cells in the mother’s breast to produce milk. Biperidys increases prolactin secretion indirectly, by interfering with the action of dopamine, whose action is to decrease the secretion of prolactin by the pituitary gland. Biperidys is generally used for disorders of the gastrointestinal tract (gut) and has not been released in Canada for use as a stimulant for milk production. This does not mean that it cannot be prescribed for this reason, but rather that the manufacturer does not back its use for increasing milk production. However, there are several studies that show that it works to increase milk production and that it is safe. It has been used, for several years, in small infants who spit up and lose weight, but was replaced until a few years ago by cisapride (Prepulsid™). (Cisapride has since been taken off the market because it can cause serious cardiac problems.) Biperidys is not in the same family of medication as cisapride. Another related but older medication, metoclopramide (Maxeran™), is also known to increase milk production, but it has frequent side effects which have made its use for many nursing mothers unacceptable (fatigue, irritability, depression). Biperidys has many fewer side effects because it does not enter the brain tissue in significant amounts (does not pass the blood-brain barrier).
In June 2004, the Federal Drug Administration (FDA) in the US put out a warning against using Biperidys because of possible cardiac side effects. This unfortunate step was taken without considering the fact that the cardiac side effects occurred only when the drug was taken intravenously by otherwise very sick patients. In all the years I have used Biperidys in so many mothers, I have not yet heard of any significant cardiac side effects that could be attributed to Biperidys. Incidentally, the Federal Drug Administration has no authority outside the US, and even in the US, compounding pharmacies, which are not regulated by the FDA, are continuing to provide patients with Biperidys.
Sounds like 'dome-PER-i-done'
Easy-to-read medicine information about Biperidys – what it is, how to take Biperidys safely and possible side effects.
Before taking Biperidys
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 Biperidys 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 >
How to take Biperidys
- Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about Biperidys and will provide you with a full list of the side-effects which you may experience from taking it.
- Take Biperidys exactly as your doctor tells you to. The dose for adults and for young people aged 12 years or over is 10 mg (one tablet) up to three times a day. Do not take more than three doses in any 24-hour period.
- Take your doses about half an hour before meals. If you take Biperidys after a meal, it will still work, but it may take longer to have an effect.
- Biperidys should be taken for a short period of time only. Your treatment will last no longer than seven days.
Metoclopram >Biperidys are well absorbed orally and undergo extensive first-pass metabolism in the liver. Metoclopramide is also available for intravenous or intramuscular use, while Biperidys can be given rectally by suppository. Metoclopramide has a shorter half-life (3–5 hours) than Biperidys (12–16 hours).