Decoding the FDA’s new labeling for NSAIDS

When a medication is sold over the counter, many Americans assume they are 100% safe, and yet recent health research and decades of use have revealed that one class of medications, non-steroidal anti-inflammatory agents, leads to an increased risk of heart attack and strokes.  I wanted to shed some light, and perspective on this topic so here are some FAQS to help you all.

WHAT MEDICATIONS ARE WE TALKING ABOUT?

NSAIDs, or non-steroidal anti-inflammatory drugs, over the counter and prescription, include ibuprofen, naproxen sodium and celecoxib. Common brands include Advil, Motrin, Aleve, Naprosyn and Celebrex and Voltaren. These medications are used for everything from fever and pain,  headaches, colds, and flu in kids to alleviating discomfort from menstrual cramps, sports-related pain and injuries, chronic or long-lasting conditions like arthritis, back pain and muscle strains in older kids and adults.

WHAT ARE THE NEW WARNINGS? WHAT’S GOING TO CHANGE?

Although NSAIDS have helped millions with acute and chronic symptoms, the FDA now recommends changing the current labeling that has been in use since 2005.  Current labels state that NSAIDS MAY cause increased risk of heart attacks and strokes.  Now manufacturers of prescription NSAIDS will be required to state: that NSAIDS CAUSE and increased risk of heart attacks and strokes.

WILL THE LABELING BE ON ALL NSAIDS, EVEN THOSE FOR KIDS?

Yes. Any non-steroidal medication in prescription form, whether pill, liquid or chewable, will be affected, as the active ingredients must comply specifically with FDA labeling. Manufacturers of OTC products have the option of voluntarily complying with the FDA’s recommendation so we are likely to see these warnings show up in the near future on products we easily can buy in the drugstore.

WHAT HAS THE NEW RESEARCH SHOWN?

1.     That those who have taken NSAIDS within a year of a first heart attack have a greater chance of death

2.     That the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID and may increase with longer use

3.     Risk appears greater at higher doses

4.     NSAIDS can increase the risk of heart attack or stroke in patients with AND without heart disease or risk factors

NOTE: Studies find that many people use them in larger doses than recommended and often like they are long-term medications. People with chronic pain or inflammation often take several NSAIDs daily, despite label warnings that the drugs should not be used longer than 10 days for pain or three days for fever.

SO WHAT SHOULD PARENTS AND KIDS DO?

First off, adhere to the recommendations for appropriate dosing on the label – whether using adult or kid versions.

1. Use no more than 10 days for pain, and no more than 3 days for fever

2. Talk with your health care provider about reasonable alternatives, especially if you or your child have been taking NSAIDS chronically.

3.  Children are born with brain or heart defects that place them at risk, or have blood conditions that pose risks for excessive clotting.  These patients, especially, need specific guidance from their doctors about the use of NSAIDS.

4.  And if parents opt to use NSAIDS for fever or pain relief, using the lowest dose possible that does the job, for the shortest amount of time, is advised.

For the average child,  we certainly want to promote an active lifestyle, a healthy diet, and minimize the use of any medication, unless absolutely necessary.  Hopefully this will grow a generation of healthier adults with less obesity, diabetes, and high blood pressure that would place them at risk for NSAID related issues.

NOTE: With all said and done, the specific concerns about heart attacks and strokes currently  center around adults, especially those with histories of heart attack, heart disease, bypass surgery and stroke, and elevated blood pressure.  The higher the dose of NSAIDs,  and the longer taken, the greater the risk, although risk can occur within the first weeks of starting NSAIDS.  NSAIDS can also reverse or lower the protective effects of a baby aspirin daily.

For a video link to this segment, go to: https://youtu.be/NABGFxqkcr8