On the FDA and Domperidone

This was found HERE. First written in June 2004 by Jack Newman, MD, FRCPC Revised February 2009 As a paediatrician who deals now only with mothers and babies who are having difficulty with breastfeeding, I am very concerned about the warning about domperidone which was issued by the Federal Drug Administration in the US on June 7, 2004. It warns breastfeeding mothers about getting domperidone to enhance milk supply because it conceivably can cause cardiac arrhythmias. The FDA has basically come up with a political statement. They seem really bothered because people were going around using a drug which they have not approved. The deaths (and I believe there were two) occurred with intravenous domperidone, which is never used any more and has never been used for enhancing milk supply. Domperidone was given intravenously in huge doses to patients who were sick with other problems as well, notably cancer for which they were getting chemotherapy. Domperidone was being used to decrease nausea and vomiting. Some patients were getting 1000 mg of domperidone every 4 hours intravenously, compared to our usual dose of 30 mg 3 times a day, taken by mouth. It is also likely that some of the chemotherapy drugs the patients would have received have cardiac side effects (for example, doxorubicin) and it was the combination of the huge doses of domperidone intravenously plus other drugs that caused the problem. Furthermore, unlike what the FDA has led people to believe, perhaps unintentionally, these are not new cases, but 2 decades old. Why didn't they mention metoclopramide in their warning, which is far more dangerous (it can cause severe depression in oral doses, which domperidone does not) and is also being used off label to increase milk supply in the US, but which, on the other hand, is available and approved for gastric motility problems in the US? Can it be that they are not concerned about the danger but rather the threat to their authority? Here is part of a letter I received about metoclopramide and domperidone as a result of this to do about domperidone. “...my mother...is on domperidone for gastroparesis. She's 5 feet tall, and lost over 20 lbs...down to 82 lbs. And why is she on domperidone? Because she had depression and SEVERE panic attacks with the Reglan (metoclopramide). She was in and out of the senior psych ward all last spring. So my folks get domperidone from outside the US.” Why didn't they mention the danger to diabetics, if they are so concerned, for whom some endocrinologists in the US are prescribing domperidone for gastric paresis? Why specifically for breastfeeding women? Why not specifically for diabetics who are at much greater risk of cardiac arrhythmias than women of reproductive age? Why did this warning come out exactly on the day that the National Breastfeeding Campaign was to begin in the US? I have used domperidone, in infants (for spitting up) but mostly to increase milk supply in women, in thousands of women, without any more than the occasional mother getting mild headaches or occasional menstrual irregularities or mild abdominal cramping as side effects. I cannot say the same for metoclopramide which I saw causing severe CNS side effects, aside from depression. I have personally seen two children die of Stevens-Johnson Syndrome after taking Septra. If I have seen two, how many have actually occurred in the US and Canada? Why no such warnings on Septra? I have, as a medical resident, seen at least one person die and several get severely ill after taking ASA, from gastric bleeding. In overdose, many children have died and many have become seriously ill over the years because of ASA. Why no such warning on aspirin? Many women have died and many more severely injured from taking the birth control pill. Why is it not banned? The issue comes up about providing a drug for women in good health and that we should not be treating healthy women with a drug. I disagree. With all the talk about preventive medicine, when it actually comes down to trying to prevent illness, it is all lip service. The data are clear. Breastfeeding decreases the risk of breast cancer and type 2 diabetes in the mother. In the baby it decreases the risk of diabetes (type 1 and 2), obesity, hypertension, high LDL/HDL levels, otitis media, asthma, and allergies, gastroenteritis, and and in premature babies, necrotizing enterocolitis. The first 4 of these are all risk factors for atherosclerosis, the most significant degenerative disease in affluent societies and the biggest killer. The data are clear that breastfeeding results in better cognitive development in children. The data are less clear, but suggestive, that breastfeeding decreases the risk of certain cancers in children (Hodgkin's and non Hodgkin's lymphoma, breast cancer in later life), multiple sclerosis and inflammatory bowel disease. Thus, we should do all that is reasonable to maintain and increase the success of woman who are breastfeeding. If this means that, in some cases, we use a drug that, in my experience of using it with thousands of women, is safe, with only minor side effects, we should have that option. Of course, there is no such thing as a drug which never causes side effects, and there are probably very few approveddrugs (yes, even approved drugs) out there that haven't killed someone, but if one weighs the risk against the benefits, domperidone can do much good. I will continue to prescribe domperidone to women when I feel it will be useful. It's a shame, though, for women in the US to be deprived of this drug. The FDA says that it will monitor the border to make sure none gets through. Good for them. With heroine and cocaine getting through their borders as through a sieve, it's great that the US can now be sure that their borders are safe against an influx of the dreaded domperidone. What a waste of manpower! What a waste! Questions? First look at the website nbci.ca or drjacknewman.com. If the information you need is not there, go to Contact Us and give us the information listed there in your email. Information is also available in Dr. Jack Newman’s Guide to Breastfeeding (called The Ultimate Breastfeeding Book of Answers in the USA); and/or our DVD, Dr. Jack Newman’s Visual Guide to Breastfeeding (available in French or with subtitles in Spanish, Portuguese and Italian); and/or The Latch Book and Other Keys to Breastfeeding Success; and/or L-eat Latch and Transfer Tool; and/or the GamePlan for Protecting and Supporting Breastfeeding in the First 24 Hours of Life and Beyond. To make an appointment online with our clinic please visit www.nbci.ca. If you do not have easy access to email or internet, you may phone (416) 498-0002. First written in June 2004 by Jack Newman, MD, FRCPC Revised February 2009

All of our information sheets may be copied and distributed without further permission on the condition that it is not used in ANY context that violates the
WHO International Code on the Marketing of Breastmilk Substitutes (1981)
and subsequent World Health Assembly resolutions.

If you don’t know what this means, please email us to ask!

The Danger Of Benzocaine Gels And Liquids

Questions & Answers: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth

On April 7, 2011, the U.S. Food and Drug Administration (FDA) warned the public about the use of over-the-counter (OTC) products containing benzocaine, an ingredient used to reduce pain in the mouth and gums. Benzocaine use may cause a rare, but serious condition where the amount of oxygen that can be carried through the blood stream is greatly reduced. This condition is called methemoglobinemia. FDA is particularly concerned about the use of OTC benzocaine products in children for relief of pain from teething because of the serious outcomes, including death, that may be associated with methemoglobinemia, as well as the difficulty parents or consumers may have in recognizing the signs and symptoms of methemoglobinemia when using these products at home. Furthermore, symptoms of methemoglobinemia may not always be evident or attributed to the condition.

Parents and caregivers should not use OTC benzocaine products on children under two years of age, except under the advice and supervision of a healthcare professional. If benzocaine products are used, it should be used sparingly and only when needed, but not more than four times a day.

Below is some additional information about benzocaine, methemoglobinemia, and steps consumers can take if they have or recognize an adverse reaction after using an OTC product containing benzocaine.

Q1. What is benzocaine?
Q2. Why is FDA concerned about the use of benzocaine?
Q3. What are the signs and symptoms of methemoglobinemia?
Q4. What should consumers do if they recognize the signs and symptoms of methemoglobinemia?
Q5. What should parents and caregivers do if they are currently using OTC benzocaine products on children who are teething?
Q6. What are alternative methods for reducing pain from teething?

Q1. What is benzocaine?

A. Benzocaine is a local anesthetic and is the active ingredient in many OTC products used to relieve pain in the mouth and gums from a variety of conditions such as teething, canker sores, and irritation of the mouth and gums.

OTC benzocaine products come in the form of gels, sprays, liquids, and lozenges. Many OTC benzocaine products are sold under the brand names listed here. Please note that there may be additional benzocaine products that are not listed. Consumers can look at the Drug Facts label when buying products used to treat pain in the mouth and gums to find out whether benzocaine is listed as the active ingredient.

Q2. Why is FDA concerned about the use of benzocaine?

A. FDA is concerned about the use of benzocaine products because they may cause a rare, but serious and possibly fatal condition where the amount of oxygen carried through the blood steam is greatly reduced. This condition is called methemoglobinemia. In the most severe cases, methemoglobinemia can result in death. Labels of OTC benzocaine products currently do notcontain warnings about methemoglobinemia, therefore, FDA is concerned that consumers may not be aware of and monitor for this condition when using OTC benzocaine products.

Methemoglobinemia with benzocaine use has been reported in adults and children. FDA is particularly concerned about the use of OTC benzocaine products in children aged two years and younger. There have been 21 reported cases of methemoglobinemia after the use of OTC benzocaine gels and liquids. Eleven of the 21 cases occurred in children two years of age or younger who were treated with benzocaine gel for teething.

Given the seriousness of the cases of methemoglobinemia, FDA will continue to evaluate the safety of benzocaine products and will update the public when additional information is available.

Q3. What are the signs and symptoms of methemoglobinemia?

A. Methemoglobinemia is a rare, but serious condition where the amount of oxygen carried by the blood is greatly reduced. Signs and symptoms of methemoglobinemia may include:

• pale, gray or blue colored skin, lips, and nail beds
• shortness of breath
• fatigue
• confusion
• headache
• lightheadedness
• rapid heart rate

Symptoms of methemoglobinemia usually appear within minutes to one or two hours after using benzocaine gels or liquids. Methemoglobinemia can occur after the first time a person uses benzocaine, or after using a benzocaine product multiple times.

Q4. What should consumers do if they recognize the signs and symptoms of methemoglobinemia?

A. Stop using the product and seek medical help immediately by calling 911.

Methemoglobinemia caused by benzocaine may require treatment with medications and may require admission to a hospital. Serious cases of methemoglobinemia should be treated promptly. If left untreated or if treatment is delayed, serious cases of methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, due to an inadequate supply of oxygen.

Q5. What should parents and caregivers do if they are currently using OTC benzocaine products on children who are teething?

A. Parents, caregivers, and consumers should not use OTC benzocaine products on children under two years of age, except under the advice and supervision of a healthcare professional. Parents and caregivers using OTC benzocaine products on children should closely watch for signs and symptoms of methemoglobinemia. These may include pale, gray or blue colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and rapid heart rate. In some cases, symptoms of methemoglobinemia may not always be evident or attributed to the condition. Symptoms usually appear within minutes to one or two hours after using a benzocaine product, and methemoglobinemia can develop after using the product for the first time, as well as after several uses. Parents and caregivers who suspect a child may have methemoglobinemia should stop using the product and seek medical help immediately by calling 911.

Parents and caregivers should keep OTC benzocaine products out of reach of children and should not allow children to use these products without supervision. Consumers should follow the directions printed on the product labeling when using OTC benzocaine products.

Parents, caregivers, and consumers should report any reactions, symptoms, or side effects from the use of OTC benzocaine products to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Q6. What are alternative methods for reducing pain from teething?

A. The American Academy of Pediatrics’ recommends the following for treating teething pain:1,2

• Give the child a teething ring chilled in the refrigerator.
• Gently rub or massage the child’s gums with your finger to relieve the symptoms of teething in children.

If these methods do not provide relief from teething pain, consumers should contact a healthcare professional to identify other treatments.

References

1. Markman L. Teething: facts and fiction. Pediatr Rev. 2009;30:e59-64.
2. American Academy of Pediatrics. Teething: 4 to 7 Months. Available at:http://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx. Accessed on March 28, 2011.

List of OTC Benzocaine Products*

Americaine	Dent’s Maxi-Strength Toothache	Orajel Medicated Toothache
Americaine Hemorrhoidal	Dermoplast Antibacterial	Orajel Mouth Sore
Anbesol	Dermoplast Painrelieving	Orajel Multi-Action Cold Sore
Anbesol Baby	Detane	Orajel PM
Anbesol Cold Sore Therapy	Dry Socket Remedy	Orajel Ultra Mouth Sore
Anbesol Jr.	Exactacain	Oticaine
Anbesol Maximum Strength	Foille	Otocain
Baby Orajel	Freez Eez	Outgro
Banadyne	HDA Toothache	Red Cross Canker Sore
Benzocaine Burn Spray	Hurricaine	Rid-A-Pain Dental Drops
Benzodent	Ivy-Rid	Skeeter Stik
Boil Ease Maximum Strength	Kanka Soft Brush	Sting-Kill
Cepacol Sore Throat	Lanacane	Tanac
Cetacaine	Lanacane Maximum Strength	Thorets
Chiggerex	Mycinettes	Topicale Xtra
Chiggertox	Navogan	Trocaine
Comfort Caine	Orabase with Benzocaine	Walgreens Oral Anesthetic Paste
Dentapaine	Orajel Denture Plus	Walgreens Zilactin-B
Dent’s Extra Strength Toothache	Orajel Maximum Strength	Zilactin Toothache and Gum Pain

*This list is not all-inclusive

Taken from:http://www.fda.gov/Drugs/DrugSafety/ucm250029.htm