This week, Daniel breaks down upcoming changes to safety labels on cold and cough medications containing opioids and what this means for your kids.
Ready? Let's talk opioids.
Recently the FDA approved new safety label requirements for opioid containing cough and cold medicines. After these safety label changes are implemented, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults 18 years and older. Link to the FDA Press Announcement.
What products does this affect?
Phenergan with Codeine® (Promethazine with Codeine), Robatussin AC® (Guaifenesin andCodeine), Hycodan® (Hydrocodone and Homotropin), Tussionex® (Hydrocodone and Chlorpheniramine), and a few others.
How do these drugs affect your children?
Many of the medications are codeine based which is usually thought of as a weaker drug than hydrocodone. The problem is that some children are what we call CYP2D6 ultra-rapid metabolizers, which means that their bodies will convert codeine into its active form of morphine much faster leading to respiratory depression. If you are curious to know more about that - take a look at this article.
However, this is not the main reason the FDA is trying to limit its use. According to the press release from last week, the FDA is trying to prevent future addiction in older children (ie teens). The concern is that unnecessary exposure to opioid drugs can lead to future addition.
Does this make it illegal for the doctor to write for this?
Absolutely not. In my experience, doctors are not writing prescriptions for opioid containing medicines often for children anyways. Even before the press release it was highly discouraged/contraindicated to prescribe these for patients that are 7 years old or younger. While some pediatric cough symptoms may require treatment, cough due to a cold or upper respiratory infection typically does not require treatment of this kind. The FDA recommends that parents of children currently prescribed cough and cold medicine containing codiene or hydrocodone talk with your child's healthcare provider to see if there are other treatment options that would work for your child.
What is my opinion on the matter?
Anything to help decrease the amount of opioids being prescribed, in my opinion, is a good thing. The U.S. is experiencing an opioid addiction epidemic so the FDA's vigilance is understandable and appropriate. The devastating effects that addiction can have on teens can lead to an entire lifetime of misery for them. While I believe the FDA made the right decision here, new safety label requirements are not a cure-all. I recommend all parents educate themselves on what is going on with this opioid epidemic and ask your child's healthcare provider questions about medications prescribed. Also, one of the best things you can do as a parent is to simply talk to your child about taking medication they are prescribed appropriately and never using someone else's prescription medication.
How can we help???
Our pharmacist will work with you to answer any questions or discuss any concerns you may have about you or your child's prescribed medications. Daniel will also help you navigate ensuring proper dosages and what over-the-counter medications may or may not be appropriate to use based on the situation. Daniel is also available to talk to you about the FDA's new safety label requirements and how it may affect your child. Give us a call or stop by Blair Pharmacy to learn more about this and other ways working with our pharmacist can benefit you and your family's health.
Have a wonderful week!
Daniel & Kim