What is benzocaine, and why is the FDA concerned about its use in OTC products for children?
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. 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. 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 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.
According to the FDA, 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.
For more information on the FDA’s safety announcement regarding benzocaine, please visit www.fda.gov.
I'm unfamiliar with the active ingredients listed on the package. Are they safe?
Active ingredients in homeopathic medicines are listed on product labels in Latin, which is the international packaging standard. Camilia contains three active ingredients: Chamomilla 9C HPUS (dilution of German Chamomile plant), Phytolacca decandra 5C HPUS (dilution of Poke plant), and Rheum officinale 5C HPUS (dilution of Rhubarb plant).
On the labels, 5C and 9C indicate the homeopathic dilution. “C,” for centesimal scale, means that each dilution is 100 times more diluted than the previous one. The number, 5 or 9, indicates how many times the substance has been diluted using this process. For instance, 5C is 100 times more diluted than 4C.
Last, the acronym “HPUS” stands for Homeopathic Pharmacopoeia of the United States. The HPUS defines the production and usage standards recognized by all reputable manufacturers and the federal government. Parents should look for this acronym on labels of homeopathic products. It ensures consumers that the ingredients were prepared according to the high standards of this official guideline.
Specifically because of their safety and reliability, homeopathic medicines are considered by many as an excellent first choice for self-treatable conditions.
I’ve heard some herbs can be dangerous depending on the amount taken or if they’re taken in combination with other substances. Are there herbs in Camilia?
All three plants that comprise Camilia’s active ingredients undergo the homeopathic manufacturing process. They are not in an herbal form. Consumers often mix up a homeopathic form of a plant with its herbal form. Furthermore, they sometimes are alarmed when they learn that some herbs are toxic when taken internally. However, homeopathic dilutions above 4C do not have the toxicity of the herb.
Like herbs, homeopathic medicines use plants (as well as minute doses of animal substances, such as the honey bee and snake venom, and mineral substances, such as zinc and copper). But plants used for homeopathic medicines do not undergo the same manufacturing process as plants that are made into herbal remedies. The main difference between these two processing methods is that the original substance is highly diluted in the manufacturing of homeopathic medicines.
Another difference is that the U.S. Food and Drug Administration (FDA) regulates herbs as dietary supplements, while regulating homeopathic medicines as drugs, with high standards of quality.
Are there side effects and dangers associated with homeopathic medicines?
Homeopathic medicines diluted above 4C have no known side effects, do not interact with other medications, and are non-toxic. This means that parents can safely administer Camilia as necessary throughout the teething phase, which can last nearly three years.
Another benefit of homeopathic medicines is that they do not mask medical emergencies. Products like Camilia work with the body instead of directly suppressing symptoms. By not concealing symptoms, patients, parents and physicians are able to detect a more serious condition right away if it would arise and can, therefore, respond faster.
Is Camilia regulated by the FDA? Has it been tested?
Homeopathic medicines, such as the three single active ingredients in Camilia, have been regulated as drugs by the FDA since 1938.1 This means that just like conventional over-the-counter drugs, homeopathic medicines are clearly labeled for specific indications and direction, making choices easier for consumers.
Unlike allopathic drugs, however, homeopathic drugs are not subject to the FDA’s new drug approval process. Homeopathic drugs also undergo the HPUS pre-market monograph approval process. The criteria for eligibility for inclusion in the HPUS require that a homeopathic drug product be determined safe and effective by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS).
Homeopathic medicines can boast of being used successfully for more than 200 years for acute and chronic therapy. Camilia has been available in the U.S. for several years. No adverse reaction linked to Camilia has been reported to the FDA.
Do I need to reduce the pre-measured dose for my infant or increase the dose for my toddler?
No, the activity of homeopathy is not weight-dependent. There’s no need to give more or less medicine to children of different ages because the activity of the medicine doesn’t depend on body weight. Follow the directions on the packaging for best results.
How much Camilia should I give my child, and when should I stop administering it?
The directions for Camilia read: “Snap off one single-use dose. Twist cap to open. Squeeze entire contents into mouth. Repeat as needed, every 15 minutes, for 2 more doses.” Repeat the dosing regimen as directed with subsequent episodes of teething.
As a homeopathic medicine, Camilia will not mask symptoms of another condition. If your child’s symptoms are not relieved after three days, or if a fever or a rash appears, check with your doctor. Your doctor or pharmacist can always call the Boiron Information Center for more technical information about Camilia. The number 1-800-BOIRON-1 is on every medicine made by Boiron.
Who is the manufacturer, and how long has it been in business? What is its reputation?
Camilia is manufactured by Boiron, world leader in homeopathic medicines. Founded in 1932 out of the need for homeopathic medicines of reliable quality, Boiron prides itself on being a state-of-the-art manufacturer. Today, Boiron is a $730 million public company with 4,000 employees in more than 80 countries. It is best known for its top-selling flu medicine, Oscillococcinum®, its Chestal® cough syrup, and its Arnicare® line of pain relievers. For nearly 80 years, Boiron has been committed to funding scientific research and educating the public and healthcare professionals on homeopathic medicines. As a pharmaceutical company, Boiron maintains the highest standards in manufacturing, complying with FDA regulations, the HPUS and drug Good Manufacturing Practices.
1 U.S. Food and Drug Administration. Sec 400.400. Conditions Under Which Homeopathic Drugs May be Marketed (CPG7132.15). Available at www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg400-400.html.
