Uploaded by USFoodandDrugAdmin on Mar 10, 2009
FDA is alerting patients and healthcare professionals about the potential danger of using topical anesthetics to relieve pain before having mammography or other medical procedures. The concern is that patients may apply these drugs improperly, which could cause excessive absorption of the drug. This could result in seizures, cardiac arrhythmias, respiratory failure, coma, and even death.
In a recent study (published in the journal Radiology) of the use of topical anesthetics to relieve pain during mammography, women spread lidocaine gel over a wide area of skin and covered it with plastic wrap before the getting the mammogram. No serious side effects from the drug were reported, but the study was too small to detect rare but serious events, like toxicity from systemic absorption.
FDA is concerned that as more women become aware of this study through the Internet or word-of-mouth, they may start using topical anesthetics without medical advice before getting a mammogram, and this could set the stage for at least a few tragic events.
FDA is aware of two cases in which the use of topical anesthetics led to fatal outcomes. In these cases, young women applied topical anesthetics before having laser hair removal. They experienced seizures, became comatose and died. They apparently applied a large amount of the drug to a large area of skin, then covered it with plastic wrap to increase the numbing effect.
Before using a topical anesthetic for a mammogram or other procedures, women should talk to their doctors about whether it is advisable to do this. If the doctor recommends using a topical anesthetic, use a product containing the lowest concentration of the drug, and apply it sparingly. To decrease the chance that the drug may be absorbed into the body, do not apply it to broken or irritated skin, do not wrap the skin, and do not apply heat to the area.
FDA Patient Safety News: March 2009
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=84#6
Category:
Tags:
- Numbing
- gel
- lidocaine
- mammogram
- mammography
- pain
- anesthetic
- wrap
- laser hair removal
- side effect
- adverse reaction
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