FDA and he Danger of Skin Numbing Products | Arthritis Information

FDA Alerts Public about Danger of Skin Numbing Products
Serious and life-threatening risks associated with improper use

The U.S. Food and Drug Administration today issued a Public Health Advisory to alert consumers, patients, health care professionals, and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available in over-the-counter (OTC) and prescription forms.

Skin numbing products are used to desensitize nerve endings that lie near the surface of the skin, causing a numbness of the skin. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. When applied to the skin surface, they can be absorbed into the blood stream and, if used improperly, may cause life-threatening side effects, such as irregular heartbeat, seizures, breathing difficulties, coma, or even death. FDA has received reports of adverse events and deaths of two women who used topical anesthetics before laser hair removal. In February 2007, the FDA issued a Public Health Advisory - “Life-Threatening Side Effects with the Use of Skin Products containing Numbing Ingredients for Cosmetic Procedures,” to warn consumers about these products.

Patients for whom an over-the-counter or prescription topical anesthetic is recommended should consider using a topical anesthetic that contains the lowest amount possible of medication that will relieve your pain. Also, health care professionals should determine whether adequate pain relief can be safely achieved with a topical anesthetic, or whether a different treatment would be more appropriate.

The FDA strongly advises consumers not to:

make heavy application of topical anesthetic products over large areas of skin;
use formulations that are stronger or more concentrated than necessary;
apply these products to irritated or broken skin;
wrap the treated skin with plastic wrap or other dressings; and
apply heat from a heating pad to skin treated with these products.

When skin temperature increases, the amount of anesthetic reaching the blood stream is unpredictable and the risk of life-threatening side effects increases with greater amounts of lidocaine in the blood.

A recently published study in Radiology looked at women taking acetaminophen and ibuprofen by mouth versus applying lidocaine gel, a topical anesthetic, to the skin to decrease discomfort during mammography. The lidocaine gel was applied to a wide skin surface area and then covered with plastic wrap. There were no serious or life-threatening side effects reported in the study, nor were any reported when FDA discussed the results with the doctor who performed the study. The study results favored the use of lidocaine as there was significantly less discomfort than with the plain gel or oral acetaminophen or ibuprofen. However, given the life-threatening side effects associated with the use of topical anesthetics during laser hair removal, FDA is concerned that similar side effects could occur when topical anesthetics are used during mammography. Further, the study was small and it is possible that a larger study might show different findings.
Patients should talk with their health care professional if they are considering using a topical anesthetic before a mammogram. The following summarizes advice for patients if a topical anesthetic is recommended for their use:

use a topical anesthetic that contains the lowest strength, and amount, of medication that will relieve the pain;
apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur;
do not apply the topical anesthetic to broken or irritated skin;
ask their healthcare professional what side effects are possible and how to lower their chance of having life-threatening side effects from anesthetic drugs; and
be aware that wrapping or covering the skin treated with topical anesthetics with any type of material or dressing can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present.

Consumers and health care professionals may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.
To read the FDA’s 2009 Public Health Advisory, go to: http://www.fda.gov/cder/drug/advisory/topical_anesthetics2009.htm

To read the FDA’s 2007 Public Health Advisory, go to: http://www.fda.gov/cder/drug/advisory/topical_anesthetics.htm

[QUOTE=Lynn49]

The FDA strongly advises consumers not to:

make heavy application of topical anesthetic products over large areas of skin;
use formulations that are stronger or more concentrated than necessary;
apply these products to irritated or broken skin;
wrap the treated skin with plastic wrap or other dressings; and
apply heat from a heating pad to skin treated with these products.

The FDA strongly advises consumers not to:

make heavy application of topical anesthetic products over large areas of skin;
use formulations that are stronger or more concentrated than necessary;
apply these products to irritated or broken skin;
wrap the treated skin with plastic wrap or other dressings; and
apply heat from a heating pad to skin treated with these products.

The FDA strongly advises consumers not to:

make heavy application of topical anesthetic products over large areas of skin;
use formulations that are stronger or more concentrated than necessary;
apply these products to irritated or broken skin;
wrap the treated skin with plastic wrap or other dressings; and
apply heat from a heating pad to skin treated with these products.

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Ooops! That's what the children's hosp. does with Emla! Applies it, then puts a clear bandage over it to send you to the lab. I've seen kids whose moms did theirs at home come in wrapped in Saran Wrap, too.

I'm glad they discovered this. Removing a big bandage from each arm kind of negated the benefit of not feeling a needlestick....
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In this instance, EMLA is only applied over a small a small area, under medical guidance/supervision. The risk increases greatly when larger areas are coated and covered.
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I don't know. Have you seen it used for kids' blood draws? I mean, they use as much as she would need for a mammogram or to laser her bikini-area. It's not just a tiny drop.

I'm refusing the plastic next time. They say it is just to keep the Emla from getting on everything while you wait for it to work. We'll just be careful.
People use Elma for a mammogram?

I tried using it once for a bit of electrolisis and it didn't even work that well. Are we such wusses we can't deal with 60 seconds of dicomfort?EMLA was used on my son when he required forehead stitches (he ran head-first into a radiator when he was a toddler). It took the pain away without any needles, which allowed him to calm down enough so that they could sew up his forehead.

Some folks have very difficult veins to tap into; I imagine that an application of EMLA beforehand makes the procedure much more bearable. Last time my stepmom was in the hospital they had a helluva time getting a good vein in her arm. She was in tears from the pain by the time the nurse finally got it 20 minutes later.

I guess she's a "wuss."

I've never had a mammogram (this year will be the first one), but I imagine there are some instances where an application of EMLA cream might be justified.
haha, jasmine, it's so cute how you can't let one post go by without pointing out how I'm wrong in some way.

Well, I guess if it makes you feel better about yourself, it's a good deed on my part. I have the gift of making you feel superior!I find it interesting that it's OK for you to put folks down ("fat" "lesbian" "wuss" "redneck") but instantly take offense if someone disagrees with you...

Toodles!
JR, I never called anyone "fat" "redneck" or "lesbian".

You people lack basic englich comprehension skills. You just put the words "fat, lesbian, and redneck": in your post, so by YOUR logic you just called me fat, lesbian, and redneck. BTW, how exactly is calling someone a "lesbian" and insult?[QUOTE=JasmineRain]EMLA was used on my son when he required forehead stitches (he ran head-first into a radiator when he was a toddler). It took the pain away without any needles, which allowed him to calm down enough so that they could sew up his forehead.

Some folks have very difficult veins to tap into; I imagine that an application of EMLA beforehand makes the procedure much more bearable. [/QUOTE]

I'm surprised they used it around an open wound - the stitches would have to be so close to it. Looks like that really wouldn't happen now with this new warning.

Yes, Emla is great when you are a patient who takes multiple tries to get a vein. That is why my daughter ends up with both arms slathered beforehand. They say some kids get more freaked out, waiting, knowing what is coming. I don't really get that - she knows what's coming when get in the car to go there. It's a normal part of the visit.

I had Emla used on my ear lobe a few weeks ago......please don't laugh or if you do, just snicker, ok? I was holding my cat when I was charged by a 3 lb. dog and my cat freaked out, clawed it's way over my head and down my back to escape 3 lbs. of rage. Left me with a lacerated ear lobe that required clean up, 5 stitches, antibiotics, and for me a tranquilizer!!! I was thankful for the spray. I think I would only have small areas sprayed and left uncovered after reading the aforementioned article.

It was interesting explaining this to the medical clinic staff in my limited Spanish and watching their faces. One of the techs had to leave the room to compose herself. Since I'm on Humira I was really worried about an infection but it healed beautifully and have felt fine. Lindy

You get a spray? My daughter gets great big generous dollops of white cream, that squishes out under the plastic.

LinB, glad you are okay! I've had freaked out cat claws on my shoulder and back before - can't imagine earlobe! Owwww.