Acetaminophen – It’s Important to Give the Correct Dose to our Children

By: Carol Holquist

It’s that time of year again – cold and flu season. For parents of infants and children, it can sometimes be difficult choosing the right medicine from the pharmacy, especially when it contains acetaminophen. And once you have made your choice, sometimes the correct dosing for your infant or child can be a challenge!

I wanted to let you know that the FDA has issued a Drug Safety Communication aimed at giving consumers like you more information about how to avoid confusion and potential dosing errors when you are giving your infant products containing acetaminophen.

There are many different brands of acetaminophen marketed for “infants” to choose from in the store. We recommend that you carefully read the labels of liquid acetaminophen before giving the medication to your child.  Giving more than the recommended dose of acetaminophen can cause serious side effects and even death.

Recently, manufacturers of acetaminophen made changes to the type of concentration available for use. Until now, liquid acetaminophen marketed for “infants” has only been available in a stronger concentration that doesn’t require giving infants as much liquid with each dose. Now there is a less concentrated form of liquid acetaminophen marketed for “infants” and both concentrations of liquid acetaminophen are in circulation.

It can be difficult to tell the two different concentrations marketed for “infants” apart from one another because all of the product labels look very similar.  We are concerned that infants and children could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused. Before giving the medication, parents and caregivers need to know whether they have the less concentrated version or the older, more concentrated medication.

Drug Facts Label

Here are some things you can do:

Please consult your pediatrician before giving this medication to make sure you’re both talking about the same concentration.

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:

  • Look for the “Active ingredient” section of the Drug Facts usually printed on the back of an OTC medication boxes.
  • If the package says “160 mg per 5 mL” or “160 mg (in each 5 mL)”, then this is the less concentrated “infant” acetaminophen.  This medication should come with an oral syringe to help you measure the dose.
  • If the package says “80 mg per 0.8 mL” or “80 mg per 1 mL,” then this is the more concentrated “infant” acetaminophen. This product may come with a dropper.
  • Use only the dosing device provided with the purchased product.
  • Consult your pediatrician before giving this medication and make sure you’re both talking about the same concentration.

If the dosing instructions provided by your healthcare provider differ from what is on the product’s label, then check with a healthcare professional before giving the medication.  If your child is under two years of age there will be no dosing provided on the products marketed for “infants”.  Please contact your healthcare provider for dosing information for children under two years of age and remember to tell them which type of medicine you have.  Do not rely on dosing information provided from other sources such as the Internet, old dosing charts, or family members.

Our goal is to protect the public health of all Americans, and we hope that this additional information on dosing for your child will be helpful.

Carol Holquist is director of FDA’s Division of Medication Error Prevention and Analysis.

Answering the Device Industry’s Call for Clarity

By: Jeffrey Shuren, M.D., J.D.

Have you ever had to puzzle through opaque instructions for operating some electronic gizmo? It can be a frustrating, time-consuming process.

Sometimes that’s how the medical device industry views FDA. They clamor for greater
clarity on a variety of agency programs, as we began to learn in 2009 when the FDA’s
Center for Devices and Radiological Health started taking a look at our pre-market

Dr. Shuren Photo

We reached out to industry during that process and they told us one of their primary concerns was a lack of clear guidance. They said their companies depend on a clear regulatory pathway to avoid unnecessary costs and bring new, safe and effective devices
to market in a timely manner. We listened, and in January, when we announced our plan to improve our pre-market programs, issuing clear guidance was an integral part of our plan.

Since then, we’ve issued several clarifying guidance documents including one on clinical trials and another on the evaluation of “de novo” devices – novel lower-risk devices. Now, as the year comes to a close, we’re out with three additional draft guidances. One outlines the process for appealing CDRH decisions. The second explains how product codes should be developed and used. And the third helps clarify how FDA decides whether a device is “substantially equivalent” to a legally-marketed device under the 510(k) program. Every year some 4,000 lower-risk devices are cleared for marketing using this streamlined process, the most common pathway to market for medical devices. This latter guidance on substantial equivalence addresses what information should be in a submission, explains how the FDA decides whether clinical data should be required, and provides a decision-making flow chart to help manufacturers through the application process, an approach we know is popular with industry. Importantly, it does not alter our review standards, the 510(k) review processes, or the agency’s data requirements. Instead, it makes the existing regulatory framework more transparent and predictable by clearly articulating many of the longstanding practices and policies underlying the 510(k) program.

At 116 pages, the substantial equivalence guidance is admittedly long, so we’ll be
offering a free online training program to walk industry through the document’s various
segments. And, like all of the other guidance we’ve issued this year, it is just draft. That
means it’s not written in stone; we’re actively soliciting feedback from industry and other
interested stakeholders.

As I look back over 2011, I can report that we have made significant progress on the
actions we committed to take this year to improve our pre-market programs. To see for
yourself, just follow this link to a table that charts our accomplishments.
Once these policies and processes are finalized and implemented, we expect to see a significant and positive impact on the pathways to market for medical devices.

Jeff Shuren is the Director of FDA’s Center for Devices and Radiological Health

FDA Voice

By: Margaret Hamburg, M.D.

I’d like to introduce you to FDA Voice – FDA’s newest communications vehicle designed to give you information from behind the scenes here at FDA, and in our own words.

FDA Voice is a new forum for us.  Although I am writing the first blog post, in the future you will see posts from a wide range of FDA officials and staff, including scientists and public health professionals, employed at headquarters here in the Washington DC area, across the United States, and in posts abroad in countries as far away as China and India.

Margaret HamburgThrough FDA Voice, we hope to give you insights on some of the most pressing public health issues of the day. For example, how does globalization affect the food that we eat? How is the pace of innovation affecting the availability of new medical treatments for you and your family? What does personalized medicine mean for me? And even, what is the latest on food safety for my pet?

I believe that providing a forum like this is especially important for an agency like FDA, where the products that we regulate are directly related to public health and the issues that we work on tend to be complex in nature. FDA Voice will give FDA employees the opportunity to go beneath the surface to tell you about what they are working on and how it impacts your life.

No matter which stakeholder group you consider yourself a member of – consumer, patient, medical professional, scientist, researcher, or industry – it is our hope that you will find this medium an unparalleled opportunity to get more details directly from the source, like details of an official trip, activities in the lab, or more background information about a policy issue or regulation.

You will find FDA Voice on our homepage – and you may notice some additional changes there today as well. We have given the homepage a cleaner look and feel – by updating the design and reducing the number of links on the page. We have been working hard to improve your experience at, and hope that the changes we have made will help you find the information you need as quickly and easily as possible.

As Americans living in the Information Age, we are always looking for new and better ways to communicate. I am glad that you decided to take time out of your day to stop by and read FDA Voice, and I hope you will make it part of your routine in the future.

On behalf of all of the employees at FDA, I wish you and your loved ones a very happy holiday season.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration.