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What You Need to Know About the New FDA Announcement

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Recently, the FDA made a surprising but necessary announcement[1]: manufacturers of certain teething medications must stop selling products intended for babies and toddlers or risk punitive action from the agency. These teething medications contain a dangerous and even deadly ingredient called benzocaine

Medicine consumers – whether prescription or over-the-counter – have become increasingly concerned with the ingredients in medicine in recent years, leading to an uplift in demand for options that are free of potentially dangerous ingredients like benzocaine. That means this new FDA regulation is a common-sense step in the right direction; regulations like these are necessary to see health-forward changes in the pharmaceutical industry.

The new FDA requirement will require manufacturers to cease celling baby or toddler teething products containing benzocaine, and to place warnings on adult products containing benzocaine. This follows many reports of dangerous side effects, including death of babies and toddlers, using the products. Regulators have previously issued warnings about the ingredient, but since nothing changed, the FDA is now taking more drastic action.

Benzocaine is a local anesthetic found in many over-the-counter medications and in prescription medications. While it can be found in cough drops or other topical pain creams, it’s most often used as an oral pain relief ointment. While it has traditionally been considered safe for adult use (despite some concerning side effects[2]), it can cause a deadly and rare blood condition in children under two years old.

Parents and caregivers should be particularly aware of these toxic side effects when discussing treatment options with their pediatrician for any of their child’s medical needs. You should carefully check the labels for all the medicines you may consider giving to yourself or your children for potentially dangerous ingredients – you may be surprised what you find in your kid’s medicines.

Thankfully, this new policy reflects the broad shift in how people are thinking about the medicines we put in our bodies. While medicine should always be safe, effective, and healthy for you and your family, that isn’t always the case yet. At Genexa, we believe medicines should be unquestionably good for you, with no potentially toxic or harmful ingredients. We make cleaner, organic medicine that is safe and effective. That’s why we’re glad to see the FDA taking measurable actions to limit these ingredients in children’s medicines, and hope to see many more steps in this direction in the near future. 

Keep checking your medicine's labels and make sure you sign up for our email list for more news and healthy content like this.

 

[1] https://www.nbcnews.com/health/parenting/us-officials-some-teething-medicines-unsafe-children-n876761

[2] https://www.consumeraffairs.com/news04/2007/02/fda_skin_numbing.html

 

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