You probably heard the news in May when major manufacturers of liquid acetaminophen, who previously made different strengths of the medicine, agreed to switch to production of a single concentration of 160 mg/5 mL in an effort to reduce dosing errors and prevent accidental poisonings in infants. But because this change to a less-concentrated version was voluntary, not all manufactures have made the change, leading to some justified confusion. Now, the FDA is reminding consumers to carefully read labels of liquid acetaminophen marketed for infants.
To avoid giving the wrong dose to your child, make sure you know whether you’re giving the less-concentrated liquid acetaminophen or the older, more-concentrated version, and follow these guidelines from the FDA:
-Read the Drug Facts label on the package very carefully to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use.
-Do not depend on a banner proclaiming that the product is “new.” Some medicines with the old concentration also have this headline on their packaging.
-Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen.
-Consult your pediatrician before giving this medication and make sure you’re both talking about the same concentration. (If your M.D. prescribes a 5mL dose of the less-concentrated liquid acetaminophen, but you give your child 5mL of the older, more-concentrated medicine, your child could have a potentially fatal overdose.) -Check with your pediatrician for dosing instructions for children under 2 years.
The ingredient (benzocaine), used in medications that soothe a baby’s teething pain, can cause a rare but serious condition known as methemoglobinemia. Methemoglobinemia reduces oxygen in the bloodstream, which can lead to death.
According to the FDA, which issued a warning in early April, the symptoms of methemoglobinemia include pale, gray, or blue-colored skin, lips, and nail beds; shortness of breath; confusion; headache; lightheadedness; and rapid heart rate. The condition is caused by gels and liquids containing benzocaine, with concentrations as low as 7.5% and symptoms can appear within minutes or hours of application.
So far, children 2 years and younger have been affected by benzocaine. The FDA warns against giving children under 2 any medication containing benzocaine, unless directed by a pediatrician. Naural ways to soothe baby’s pain include giving your child a chilled teething ring or rubbing/massaging the gums with your fingers, suggests the American Academy of Pediatrics. Otherwise, seek advice from a healthcare professional.
Name-brand medications that include benzocaine are Baby Orajel, Orajel, Anbesol, Hurricaine, and Orabase. However, there are still benzocaine-free OTC teething medicines available. Church & Dwight, the makers of Orajel, have released Baby Orajel Naturals, which contains clove oil instead of benzocaine, alcohol, and dye to relieve teething symptoms. They are also working with the FDA to determine the best actions for using benzocaine in children under 2 years old. Boiron has also released a homeopathic teething medicine called Camilia that comes in pre-measured, individual doses and is free of benzocaine, preservatives, flavors, dyes, and sugar/artificial sweeteners.
Last week’s announcement that OTC drug manufacturers will no longer produce liquid acetaminophen for infants brought up an issue that’s been percolating for a while: mistakes we make when giving medicine to our children. Some of the most common errors parents have been known to make are:
* using the incorrect dosing tool (whether it’s a household spoon, or a cup or syringe from a different medication)
* basing the amount of medicine on the child’s age, instead of his weight
* using expired meds
* giving medication to a child that was prescribed for her sibling
* giving adult medicines to a child (Note: simply halving or reducing the dose is not safe and never recommended).
Unfortunately it’s not hard to make a mistake like any of these, especially when it’s the middle of the night, and when you’re desperate to offer your child some measure of comfort. Eventually, FDA guidelines will call for clearer packaging and measuring devices, including cups that will still be easy to read even when there’s medicine inside. They won’t contain two sets of measurements, either (do we really need teaspoons when the dosages are given in millileters?).
These steps will help, but not totally solve the problem. I know moms who have made all of the errors listed above, and I’ve done one or two of them myself. How about you? Care to share? Have you ever made a mistake when giving medicine to your child?
The Consumer Healthcare Products Association (CHPA), a non-for-profit group that represents OTC drug manufacturers, decided on this step to reduce dosing errors and prevent accidental poisonings in infants. Currently, liquid acetaminophen is sold in two concentrations: 80 mg/0.8 mL or 80 mg/1.0 mL, with droppers for infants; 160 mg/5 mL, with cups for children ages 2-11. The two different concentrations have often caused confusion, leading parents to give kids incorrect doses due to badly-marked droppers or cups.
Johnson & Johnson and other drug manufacturers will cease production of the 80 mg/0.8 mL and the 80 mg/1.0 mL concentrations through 2012. Instead, 160 mg/5 mL will become the standard concentration for all ages, along with cups for older kids and new syringes with flow restrictors for infants, which will provide accurate dosing and reduce spills. Most medications with acetaminophen do not have proper dosing instructions for kids under 2 years; instead, the labels instruct parents to contact pediatricians. Tylenol, produced by Johnson & Johnson, will be working on a case to urge the Food and Drug Administration (FDA) to include correct acetaminophen dosing information for children 6 months and up on labels.
For now, both concentrations will still be on shelves until CHPA can work with retailers to remove the infant concentrations. Parents can keep acetominophen medications they already have or purchase them in stores, but read labels and dosing directions carefully. Always consult a trusted pediatrician to clarify the concentration of your child’s dose, especially if you have any questions or concerns.
Based on the research, the U.S. Food and Drug Administration (USDA) warned parents against giving OTC medication to kids of that age range. Despite the warning, a national poll conducted with 300 parents revealed that 61% were still giving OTC medicine to kids 6 months to 2-years-old. More than half of the parents also revealed their doctors saying the medicines were safe and effective for younger kids.
While the expertise of a medical professional is important, pediatricians and parents should take heed that OTC medication can be dangerous for younger kids. To medicate your child safely, always consult USDA guidelines or ask for prescribed medicine that’s not purchased over the counter.
Parents who depend on Children’s Zyrtec Chewable Tablets to treat their kids’ allergies will need to speak to their pediatricans about other safe, alternative over-the-counter medication. Mitch Lipka on Consumer Ally reports the tablets are not being recalled, but being made unavailable until 2012 because of changes in production and manufacturing.
According to Consumer Ally, after McNeil recalled Children’s Benadryl Allergy Fastmelts, Motrin Junior Strength Caplets, and other medication last year, Johnson & Johnson recommitted to producing medication “to the levels of quality and compliance that consumers expect….” Johnson & Johnson’s McNeil Consumer Healthcare recently made the decision to stop outsourcing production of Zyrtec Chewable Tablets and begin manufacturing them in-house, which means they won’t be ready until next year.
When you go to your medicine cabinet and find the bottle of liquid meds you’re looking for, but not the dosing cup it came with, what’s your next move? Do you wing it and use a kitchen spoon, using your best guess to pour the correct amount? If you do, it’s time to rethink that strategy. A recent study from Greece found that parents who use household spoons to administer medicine to their children could be giving nearly 200 percent more than they should.
It’s so easy to lose the cups that come with oral medicines, so do yourself a favor and go pick up a few medicine syringes from your local drugstore and keep them wherever you store your meds. That’s a cheap, simple way to sidestep what could become a big problem.