Prokinetics: What You Should Know – by Nancy Brown

Prokinetics: What You Should Know

by Nancy Brown

5/25/17

Prokinetics are class of medications that enhance motility for those who suffer from Gastroparesis and other slow motility diseases.  They are prescribed to improve the nausea, vomiting and bloating symptoms that people with those diseases commonly suffer from.

Prokinetics work by increasing movement of the stomach and intestines, improving overall digestion.  There is currently only one FDA approved prokinetic for Gastroparesis, though other prokinetics are prescribed off-label by doctors.  Off-label drugs were developed for other purposes, but have been found to improve motility for some Gastroparesis patients.  Below is a description of several prokinetics:

  Prokinetic Requires Rx Avail in US Recommended Duration of Use FDA Approved for GP
Metoclopramide

(Reglan)

YES YES No more than 3 months unless otherwise approved by doctor YES
Domperidone

(Motlium)

YES NO Depends on medical condition NO*
Erythromycin

(Erythrocin)

YES YES No more than 3 months unless otherwise approved by doctor NO
Tegaserod

(Zelnorm, Zelmac)

YES NO Restricted usage for emergency only NO

*Domperidone is actually approved for Gastroparesis patients but doctors must obtain advanced approval from the FDA to prescribe it.

Metoclopramide (Brand names include Reglan, Metozolv ODT, and PCP 100) is the only FDA approved drug for Gastroparesis.  It aids in digestion by causing stomach muscles to contract.  Metoclopramide also decreases incidents of nausea and vomiting.  Metoclopramide may cause tardive dyskinesia, a serious movement disorder.  The risk of tardive dyskinesia increases if Metoclopramide is used for longer than 12 weeks. Talk to your doctor about the risks and benefits of this medication.

Domperidone (Brand name Motilium) is approved in Canada, Europe, Japan and other countries, but not in the US. Originally developed to enhance breast milk production in lactating women, the FDA did not approve Domperidone due to risk of cardiac arrhythmias or cardiac arrest.  The FDA recognizes that Domperidone improves motility, nausea, and vomiting.  Doctors must request FDA approval to prescribe and order Domperidone.

Erythromycin is used to treat and prevent a variety of bacterial infections.  It speeds up motility, but its effectiveness reduces after several weeks of use.   Intravenous Erythromycin used in a hospital setting is effective for patients with severe Gastroparesis.  Lower doses of oral erythromycin improve Gastroparesis symptoms; unfortunately, side effects include stomach cramps and nausea.

Tegaserod (Brand name Zelnorm or Zelmac) is only available for emergency situations with approval by the FDA.  Originally developed for treatment of Irritable Bowel Syndrome (with diarrhea) or Chronic Idiopathic Constipation, Tegaserod increased stomach emptying and movement through the bowels.  Due to FDA concerns with cardiovascular side effects, it was removed for use in 2007.

The following drugs are in use for Gastroparesis, but they are not available in the US:  Levosulpiride, Mosapride Citrate, Itopride hydrochloride, and Pruclopride.

 

Future developments:

A clinical study has been completed in the US for Renzapride.  This drug is currently being developed by EndoLogic LLC for distribution.  Renzapride was tested for both gastroparesis and IBS-D.

Several other clinical trials are in process for evaluating drugs (beyond prokinetics) to treat Gastroparesis:  Promethazine, VLY-686, Prucalopride, RQ-10 (Parkinson and Gastroparesis) and Lixisenatide.  Please refer to https://ClinicalTrials.Gov and search for Gastroparesis for additional information on clinical trials.

Prokinetic medications may not be an option for all Gastroparesis patients.  Side effects may be too severe or the prokinetic may interact with other medications the patient is prescribed.  Gastroparesis patients often use prokinetics in combination with other treatment options or not at all.  Gastroparesis patients should work with their doctor to determine the best treatment plan based on the severity of gastroparesis.

 

About the author:

Nancy Brown lives in Virginia with her husband of 38 years, Ed.  They’re empty nesters and are enjoying retirement.  Prior to retiring, Nancy was a Manager of Requirement Analysis at Navy Federal Credit Union.

Resources for article:

http://webmd.com
http://www.aboutgastroparesis.org/medications.html
http://www.digestivedistress.com/motility-rx
http://www.medscape.com/viewarticle/514206_4
https://clinicaltrials.gov/ct2/show/NCT02130622?term=gastroparesis&recr=Open&rank=3
https://globenewswire.com/news-release/2017/01/03/902783/0/en/EndoLogic-Acquires-Renzapride-from-Alizyme-plc.html
https://www.fda.gov
https://www.ncbi.nlm.nih.gov

IT’S OKAY NOT TO BE OKAY

In this guest post by writer and runner Samantha H Smith, we hear about loss – sadly, an ongoing problem in the gastroparesis community. Samantha has dealt with plenty of it, but she finds strength somehow.

“It’s Okay Not To Be Okay” – by Samantha Smith 05/15/17

I’ve been sitting here trying to write about loss for a few days now. Some days, my mind just doesn’t want to form words, or even try to comprehend all the emotions I’m feeling.

Recently, the GP community lost a sister; a brave and beautiful soul who meant the world to many people. I myself considered her a good friend; someone I was truly lucky enough to know and love. She was the kind of person who no matter what she had going on, she made time for you.

When I was at my sickest, and TPN became a reality, Dalia was right there, offering hope, advice and comfort. I’d always considered her a friend, but it was during that time that we grew close.

Everyone will experience loss at one time or another. Someone in your life may die. You may lose a job, a friendship, or a significant other. Loss is difficult, but loss is normal. I want you to know, it’s OKAY to not be okay. It’s okay to have bad days. Some days, the pain will be less, and you may be fine. Some days, the pain may be so overwhelming you can’t get out of bed. I’ve learned to be okay with myself during both days.

Just remember, it won’t last forever. Things will get better. You WILL be okay.

 


Samantha is 27, from upstate NY. She lives with a few chronic illnesses, one being Gastroparesis. She has a Bachelors degree in forensic psychology that she hopes to have a career in someday. Writing and running are both passions of hers. You can find more of her writing at her blog https://hustleandheart2016.wordpress.com/ .

Image credit: www.snappygoat.com

 

Skateboarding my way to health

By Rita Griffin

Skateboarding My Way to Health: Johnathan’s Journey with GP

 

Barbados, a Caribbean paradise that invites travelers to its magnificent beaches, is home to a courageous thirteen year-old boy, who is battling gastroparesis. His story is an inspirational and uplifting one, of how a young person can face difficult challenges with grace and determination.

Gastroparesis, a rare under-served disease often associated with young women, has no respect of persons. According to digestivedistress.com, “The National Institute of Health in the United States has declared that 5 million Americans are afflicted.” Of this staggering number one-third are idiopathic, meaning that there is no clearly identifiable cause for the illness. Even though the majority of sufferers are female, many males are being diagnosed from young to old.

Johnathan began his journey with GP in 2014 when he was only ten years old. He started experiencing constant vomiting and nausea. He was taken to five doctors in Barbados, but they could not figure out what was wrong. Johnathan stated, “One doctor thought it was constipation and gave me a laxative, luckily my family stopped giving it to me and took me to another doctor.”

He also suffered with acid reflux, and this added to the distress of vomiting and nausea. So, his parents brought him to the United States to the Arnold Palmer Hospital, where numerous tests were done. Johnathan explains, “After a 24 hour motility test at the hospital, the specialist indicated that the antrum of my stomach had flat lined, and that I had no activity. It was severe gastroparesis and no medicine had an effect on me.”

Despite hearing such devastating news, Johnathan’s parents helped him learn how to cope with his sickness. They were his mental support with care and understanding. Besides, he was only ten years old when he started getting sick, and his future had not been mapped out.  When he heard this devastating news, Johnathan was just a young boy who wanted to skateboard and go to school.

He was in the top of his class. Due to his challenges with GP, he missed two years of school. Yet, he never gave up! He was determined to achieve and to live, a determination which is crucial to overcoming any obstacle in life, especially a debilitating illness.

He was formally diagnosed in February 2014. Though he knew the cause of his vomiting and nausea, he got progressively worse. He was taking Reglan and it worked for only three months. He started vomiting again with bad stomach pains, causing him to lose weight. “I spent a month in hospital in October 2014 and they put a GJ tube in me to feed, as nothing would stay down and I only weighed 54 pounds.”

map-of-intestines

A GJ tube or Gastro-Jejunal is often used in severe GP patients. It is placed in the stomach and attached to the jejunal portion of the small intestine. From November 2014 to last September (2015), Johnathan could not eat, and was fed through the GJ tube for 18 hours a day. Courageously, he says, “ I got accustomed to walking with my milk either in a bag or walked around pulling my IV feeding pole.” Johnathan did not allow his circumstances to dictate his life. He amazingly endured the inconveniences of the feeding tube, and persisted with a positive attitude of getting well.

Last September (2015), he was fitted with a Gastric Pacemaker or Stimulator, and was taken off the GJ tube. This electrical device provides mild electrical stimulation to the lower stomach nerves. According to the California Pacific Medical Center, this device is placed below the rib cage in the abdomen, and mild electrical pulses are transmitted through a neurostimulator encouraging the stomach to contract, and to help relieve nausea and vomiting. This procedure worked for a month before Johnathan’s symptoms returned. He had to travel from Barbados to the hospital in the states to have the stimulator adjusted. The device would work for a short while and then the symptoms of vomiting would return.

The pacemaker was not having a lasting effect on Johnathan’s gastroparesis, so he discontinued its use and went back on the feeding tube. This therapy is reversible, and can be turned off at any time by the specialist. During this time, he had to go back to the hospital and it was discovered during several tests that the leads for the pacemaker were placed too low on the stomach, and needed to be higher to have a better effect. The changes were performed in April; however, he developed an infection so in May, they removed the pacemaker and sanitized the area. The pacemaker was replaced. Johnathan says, “I have been feeling better since May.” He was able to return to school after missing two years.

The pacemaker is working greatly according to Johnathan’s father. The feeding tube is also used just for insurance. Johnathan is not taking any medication other than an antacid once and a while, and Zofran for occasional nausea. “I am able to eat breakfast, lunch, a snack, and dinner. Some days I do not feel hungry at meal time. I also feel nausea sometimes, but much less than before.” His enthusiasm and passion for skateboarding is his therapy. Now, he is able to skateboard for 2-3 hours a day. He has also resumed his schoolwork and is doing quite well.

His favorite movie is Miracles from Heaven, about a young girl suffering from a rare digestive disorder who finds herself miraculously cured after surviving a terrible accident. The movie was very similar to what Johnathan experienced with GP, except as he points out, “My miracle came in the form of a pacemaker.”

Johnathan’s hope and courage is an inspiration for how we can overcome the challenges life presents. His determination is summed up in these words of encouragement: “Always believe in the person suffering with GP. It is frustrating when a doctor tells you that it may be in your head, when they do not know what is wrong. Research is the key towards understanding the illness and searching for a solution. Always keep fighting and remain positive. Life will get better with the right treatment. Never give up!”

Related sources used:

www.cpmc.org (California Pacific Medical Center)

www.digestivedistress.com

www.feedingtubeawareness.org

Rita Griffin is a Georgia native. She has a Bachelor of Science degree in Psychology and worked for the Georgia Department of Transportation for 15 years. She loves studying the Bible, reading, traveling, writing, and meeting people. Rita has published 4 books of poetry. She is married with two sons. Rita is a volunteer writer for G-PACT.

The PIE FACE CHALLENGE

This article from David Wilson of Itemlive.com introduces a young man named Andrew Billeveau. See the article where Andrew talks about his gastroparesis and how to raise money and awareness he took part in The Pie Face Challenge article. !

web-lorenz_161229_002-695x393
Andrew Billeveau post pie!      [photo by Mark Lorenz from the Itemlive.com article]
The article mentions G-PACT and our own Operations Director Colleen Beener.

Visit G-PACT’s own Pie Face Challenge on Facebook.

The PIE FACE CHALLENGE builds on the popularity of the ALS Ice Bucket challenge of 2015. The rules are simple:

  1. make a photo or video of you smashing a cream pie in your face!
  2. challenge your friends to do the same
  3. make a donation to G-PACT.org
  4. spread the word

gp-pie-face-challenge-flyer

Amitriptyline: A Sound Release

by Rita Griffin

Both constant and periodic vomiting and nausea plagued my son off and on for several years during high school. When he entered college in 2011, the frequency of stomach upsets increased. Numerous visits to the emergency room interrupted his college experience, and made his life unbearable.

In the fall of 2014, he was finally diagnosed as having idiopathic gastroparesis. The gastroenterologist, at that time, had first thought that he had cyclic vomiting syndrome. However, after performing the gastric emptying study, it was concluded that he indeed had gastroparesis.

Now that we knew what the problem was, it was decided by the doctor to prescribe nortriptyline, a tricyclic antidepressant, which helped alleviate the nausea for a while. The gastroenterologist was hesitant when he prescribed Reglan (metoclopramide), despite the overt side effects. Neither drug was helping my son, who at this time, was suffering emotionally from being sick, and missing college classes.

Another doctor with GP sufferers in his practice recommended placing my son on amitriptyline, also a tricyclic antidepressant. He also wanted him to cease gradually from the Reglan. My son stopped taking nortriptyline, and has now ceased from the Reglan.

Happily, I can say that amitriptyline has really aided my son with the nausea and vomiting associated with gastroparesis. Yet, he still has to avoid spicy, acidic foods to get the full potential of the drug.

Amitriptyline is used to help relieve symptoms of depression. My son takes his at bedtime, because it can cause drowsiness (his only complaint in the last six months). His local GI doctor and the GP specialist have both advised that they can increase his dosage, if needed. The highest dosage recommended is 150mg.

At first I was unaware that amitriptyline was used to treat depression. I could not understand how this could help with gastroparesis. After careful study, I learned that the drug works on the central nervous system to increase levels of certain chemicals in the brain. His GI doctor told us that stress could be a factor in our son’s sickness, because around the time of college exams and tests, his condition would worsened.

My son has shown no episodes of nausea, only rare occasions of pain. Pain is common with GP. When I first saw my son bent over in agony, I told him to stay calm and be more relaxed thinking that would help, but I did not really understand the pain he was experiencing. Based on my readings and information from the GP specialist doctor, the cause of GP related pain is unknown. The GP specialist who prescribed amitriptyline for my son gave an interesting finding in a report with the International Foundation for Functional Gastrointestinal Disorders (IFFGD, regarding tricyclic medications: “Low doses of trycyclic medications, such as amitriptyline, nortriptyline, and desipramine, have been shown to reduce pain in other functional gastrointestinal (GI) conditions and may reduce pain associated with gastroparesis.” The amitriptyline seems to help my son with pain.

As with all medications, there are diverse side effects. According to healthline.com the most common are “headache, constipation or diarrhea, confusion, numbness or tingling in arms and legs, unexpected weight gain or loss. The more serious side effects are chest pain, shortness of breath, weakness on side of body and slurred speech. There can also be interactions with herbs and vitamins.” So, it is important to check with your doctor before taking anything else while on amitriptyline.

Taking too much can lower your blood pressure and cause an irregular heart rate, confusion, hallucinations, and even convulsions. Your physician must monitor dosages. In fact, the Mayo Clinic advises that a doctor should check you at regular intervals for changes in dosage or to check for unwanted side effects. Amitriptyline may cause some people to be agitated, irritable, or display other abnormal behaviors.

Amitriptyline has given my son much needed relief from the nausea and vomiting associated with gastroparesis. In addition to the medication, he does chiropractic care, which has proven to be a positive benefit. My son has his spinal cord adjusted about once a month. The Chiropractor uses his hands “ to apply a specific application of forces to facilitate the body’s correction of nerve interference.” [Chiropractic First, page 67] This helps to relax his stomach muscles.

My son has no other medical conditions, and he gets a good report from his general practitioner visits. He has to be conscious of his diet. This has to be the most daunting aspect for him because he is young, and like young people, he wants to be able to eat whatever he wants. Usually, he does okay when he takes his medication and adheres to what he has to do to stay healthy.

Amitriptyline may not be a cure, but it has proven to be a constant relief for my son. Until a cure, he can at least experience a sound release from the pitfalls of gastroparesis.

Related Sources

www.healthline.com

www.MayoClinic.org

www.aboutgastroparesis.org

www.drugs.com

Rondberg, Terry A., D.C., Chiropractic First, The Chiropractic Journal, 1996 & 1998

Rita Griffin is a Georgia native. She has a Bachelor of Science degree in Psychology and worked for the Georgia Department of Transportation for 15 years. She loves studying the Bible, reading, traveling, writing, and meeting people. Rita has published 4 books of poetry. She is married with two sons. Rita is a volunteer writer for G-PACT.

 

The Domperidone Problem – The Goldwater Institute tells the story

Domperidone is a drug that has been used to treat patients with gastroparesis. It is not available by prescription in the United States, and while it was once able to be formulated in compounding pharmacies, that practice has been banned by the FDA. Domperidone is also available in many other countries, including Canada, but the FDA has blocked those channels for acquiring the drug as well.

Why is such a successful medication being targeted by the FDA?

The Goldwater Institute’s Mark Flatten has, with cooperation from G-PACT, written a powerful article explaining the many problems patients face getting access to Domperidone, titled, SICKENING: FDA BUREAUCRACY BLOCKS COMMON “MIRACLE DRUG”

We encourage you to read it. Then we encourage you to take action with your legislative representatives.

Learn more about Domperidone from The Mayo Clinic, here.

See what the Food and Drug Administration have to say about Domperidone and how to get it, here.

 

The Right-To-Try legislation

Right To Try is a legislative effort to expand the ability of terminally ill patients to gain access to experimental medicines. It would prohibit the federal government, including the US Food and Drug Administration, from taking any action to prevent patient access to life saving treatments.
“The FDA does have its own Compassionate Use program aimed at providing access to therapies still under evaluation — however the application is cumbersome, largely unworkable for practicing physicians, and time consuming when a patient’s time is running out. State Right-to-Try laws give patients who have exhausted every government-approved option another chance to fight for their lives. The laws are aimed at reducing the often two to four month waiting period under the FDA’s Compassionate Use down to two to four weeks, and eventually two to four days.”

To learn more search “Right-to-try legislation”