Topical Anesthetic Use
Topical anesthetics are widely used to numb the skin for medical and cosmetic procedures and to relieve pain and burning and itching due to a variety of medical conditions. The FDA has approved many products for these uses. Some must be prescribed by a doctor; others may be purchased without a prescription.
To provide the effective pain control needed for effective laser procedures — including laser hair removal — other agents, particularly topical lidocaine, are often used when the analgesia provided by cooling tips is inadequate.
Complications Associated with Lidocaine
Although the lidocaine is applied to the skin, such a topical anesthetic can induce shock and, on rare occasions, death1 as a result of systemic absorption leading to:
1. methemoglobinemia
2. cardiac arrest
3. idiosyncratic reaction.1-7
Methemoglobinemia as a complication of topical lidocaine used during endoscopic procedures and before circumcisions in infants has resulted in loss of consciousness, coma, and even death.2
The package insert for EMLA (a eutectic mixture of lidocaine and prilocaine in an emulsion base), which is useful for analgesia in neonatal male circumcision, was changed in 1999 to limit its indication in pediatric patients younger than 1 month of age to those infants whose gestational was at least 37 weeks or greater. In babies 0 to 2 months of age, the maximum dose should be 1 g applied over a maximum skin area of 10 cm2
In 2006, the package insert of EMLA was changed to include warnings that it be used with caution in patients receiving concurrent therapy with class 3 anti-arrhythmic drugs because of the risk for additive cardiac effects. Close surveillance and electrocardiogram monitoring is advised. The product should not be used in the setting of potential migration to the middle ear due to the risk for ototoxicity.1
Fatalities Related to Use in Large Areas
Several fatalities in which topical lidocaine combined with other agents was applied over large areas with or without occlusion have been reported.
*This includes a case in 2000, when a 20-year-old Coast Guard cadet died as a result of an allergic reaction and cardiac arrest after EMLA cream was applied as a topical anesthetic to his back prior to planned laser hair removal by a plastic surgeon in McLean, VA. His parents filed a wrongful death lawsuit and settled the case for $725,000.2
FDA Warnings
Applying topical anesthetics for a medical procedure is usually done in a doctor’s office by a trained medical professional.
Unsupervised Application by Patients
However, FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of topical anesthetics to their skin. This application can result in high levels of these products in the blood, causing life-threatening side effects, such as an irregular heartbeat, seizures, and death.
On Feb. 8, 2007, the U.S. Food and Drug Administration (FDA) issued a warning to healthcare professionals regarding potential risks associated with unsupervised patient use of topical anesthetic products.7
The FDA noted that these topical anesthetics contain drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment or gel.
Public Health Risks from Compounded Topical Anesthetic Creams
These February 2007 warnings followed the warning the FDA issued in December of 2006 to five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients.8
The FDA noted that Firms that did not resolve violations in FDA warning letters risked enforcement such as injunctions against continuing violations and seizure of illegal products.8
Specifically, the FDA was concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats.8
The two deaths mention in the February 2007 FDA advisory letter were connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy, two of the five pharmacies receiving warning letters. Similar topical anesthetic creams are compounded by the other firms, and today’s action serves as a general warning to firms that produce standardized versions of these creams.8
“Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high-potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research commenting on the December 2006 warnings.8 The FDA advised consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.8
Toxicity Threshold for “Caine” Type Drugs
I have not found instances of serious side effects involving lidocaine 4% cream (LMX4) or lidocaine 5% cream (LMX5) that have resulted in death, but this does not mean that LMX is without side effects. The threshold for toxicity of “caine” type drugs is not clear. An article discussing the use of “caine” drugs in dentistry pointed out that adverse reactions to dental anesthetic may be due to true allergy, psychogenic reaction (syncope), normal toxic overdose, or idiosyncratic toxic overdose.6
Recommendation
While the cases and facts that I have adduced do not mean that topical lidocaine should not be used to effect topical pain relief, they strongly suggest that topical lidocaine should be used with care and that its use on large areas (the back is 18% of body surface and each leg another 18%) should be approached with caution and a knowledge of potential side effects.
Topical Anesthetic Use
Topical anesthetics are widely used to numb the skin for medical and cosmetic procedures and to relieve pain and burning and itching due to a variety of medical conditions. The FDA has approved many products for these uses. Some must be prescribed by a doctor; others may be purchased without a prescription.
To provide the effective pain control needed for effective laser procedures — including laser hair removal — other agents, particularly topical lidocaine, are often used when the analgesia provided by cooling tips is inadequate.
Complications Associated with Lidocaine
Although the lidocaine is applied to the skin, such a topical anesthetic can induce shock and, on rare occasions, death1 as a result of systemic absorption leading to:
1. methemoglobinemia
2. cardiac arrest
3. idiosyncratic reaction.1-7
Methemoglobinemia as a complication of topical lidocaine used during endoscopic procedures and before circumcisions in infants has resulted in loss of consciousness, coma, and even death.2
The package insert for EMLA (a eutectic mixture of lidocaine and prilocaine in an emulsion base), which is useful for analgesia in neonatal male circumcision, was changed in 1999 to limit its indication in pediatric patients younger than 1 month of age to those infants whose gestational was at least 37 weeks or greater. In babies 0 to 2 months of age, the maximum dose should be 1 g applied over a maximum skin area of 10 cm2
In 2006, the package insert of EMLA was changed to include warnings that it be used with caution in patients receiving concurrent therapy with class 3 anti-arrhythmic drugs because of the risk for additive cardiac effects. Close surveillance and electrocardiogram monitoring is advised. The product should not be used in the setting of potential migration to the middle ear due to the risk for ototoxicity.1
Fatalities Related to Use in Large Areas
Several fatalities in which topical lidocaine combined with other agents was applied over large areas with or without occlusion have been reported.
*This includes a case in 2000, when a 20-year-old Coast Guard cadet died as a result of an allergic reaction and cardiac arrest after EMLA cream was applied as a topical anesthetic to his back prior to planned laser hair removal by a plastic surgeon in McLean, VA. His parents filed a wrongful death lawsuit and settled the case for $725,000.2
FDA Warnings
Applying topical anesthetics for a medical procedure is usually done in a doctor’s office by a trained medical professional.
Unsupervised Application by Patients
However, FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of topical anesthetics to their skin. This application can result in high levels of these products in the blood, causing life-threatening side effects, such as an irregular heartbeat, seizures, and death.
On Feb. 8, 2007, the U.S. Food and Drug Administration (FDA) issued a warning to healthcare professionals regarding potential risks associated with unsupervised patient use of topical anesthetic products.7
The FDA noted that these topical anesthetics contain drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment or gel.
Public Health Risks from Compounded Topical Anesthetic Creams
These February 2007 warnings followed the warning the FDA issued in December of 2006 to five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients.8
The FDA noted that Firms that did not resolve violations in FDA warning letters risked enforcement such as injunctions against continuing violations and seizure of illegal products.8
Specifically, the FDA was concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats.8
The two deaths mention in the February 2007 FDA advisory letter were connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy, two of the five pharmacies receiving warning letters. Similar topical anesthetic creams are compounded by the other firms, and today’s action serves as a general warning to firms that produce standardized versions of these creams.8
“Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high-potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research commenting on the December 2006 warnings.8 The FDA advised consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.8
Toxicity Threshold for “Caine” Type Drugs
I have not found instances of serious side effects involving lidocaine 4% cream (LMX4) or lidocaine 5% cream (LMX5) that have resulted in death, but this does not mean that LMX is without side effects. The threshold for toxicity of “caine” type drugs is not clear. An article discussing the use of “caine” drugs in dentistry pointed out that adverse reactions to dental anesthetic may be due to true allergy, psychogenic reaction (syncope), normal toxic overdose, or idiosyncratic toxic overdose.6
Recommendation
While the cases and facts that I have adduced do not mean that topical lidocaine should not be used to effect topical pain relief, they strongly suggest that topical lidocaine should be used with care and that its use on large areas (the back is 18% of body surface and each leg another 18%) should be approached with caution and a knowledge of potential side effects.
Topical Anesthetic Use
Topical anesthetics are widely used to numb the skin for medical and cosmetic procedures and to relieve pain and burning and itching due to a variety of medical conditions. The FDA has approved many products for these uses. Some must be prescribed by a doctor; others may be purchased without a prescription.
To provide the effective pain control needed for effective laser procedures — including laser hair removal — other agents, particularly topical lidocaine, are often used when the analgesia provided by cooling tips is inadequate.
Complications Associated with Lidocaine
Although the lidocaine is applied to the skin, such a topical anesthetic can induce shock and, on rare occasions, death1 as a result of systemic absorption leading to:
1. methemoglobinemia
2. cardiac arrest
3. idiosyncratic reaction.1-7
Methemoglobinemia as a complication of topical lidocaine used during endoscopic procedures and before circumcisions in infants has resulted in loss of consciousness, coma, and even death.2
The package insert for EMLA (a eutectic mixture of lidocaine and prilocaine in an emulsion base), which is useful for analgesia in neonatal male circumcision, was changed in 1999 to limit its indication in pediatric patients younger than 1 month of age to those infants whose gestational was at least 37 weeks or greater. In babies 0 to 2 months of age, the maximum dose should be 1 g applied over a maximum skin area of 10 cm2
In 2006, the package insert of EMLA was changed to include warnings that it be used with caution in patients receiving concurrent therapy with class 3 anti-arrhythmic drugs because of the risk for additive cardiac effects. Close surveillance and electrocardiogram monitoring is advised. The product should not be used in the setting of potential migration to the middle ear due to the risk for ototoxicity.1
Fatalities Related to Use in Large Areas
Several fatalities in which topical lidocaine combined with other agents was applied over large areas with or without occlusion have been reported.
*This includes a case in 2000, when a 20-year-old Coast Guard cadet died as a result of an allergic reaction and cardiac arrest after EMLA cream was applied as a topical anesthetic to his back prior to planned laser hair removal by a plastic surgeon in McLean, VA. His parents filed a wrongful death lawsuit and settled the case for $725,000.2
FDA Warnings
Applying topical anesthetics for a medical procedure is usually done in a doctor’s office by a trained medical professional.
Unsupervised Application by Patients
However, FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, a patient may apply large amounts of topical anesthetics to their skin. This application can result in high levels of these products in the blood, causing life-threatening side effects, such as an irregular heartbeat, seizures, and death.
On Feb. 8, 2007, the U.S. Food and Drug Administration (FDA) issued a warning to healthcare professionals regarding potential risks associated with unsupervised patient use of topical anesthetic products.7
The FDA noted that these topical anesthetics contain drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment or gel.
Public Health Risks from Compounded Topical Anesthetic Creams
These February 2007 warnings followed the warning the FDA issued in December of 2006 to five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients.8
The FDA noted that Firms that did not resolve violations in FDA warning letters risked enforcement such as injunctions against continuing violations and seizure of illegal products.8
Specifically, the FDA was concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats.8
The two deaths mention in the February 2007 FDA advisory letter were connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy, two of the five pharmacies receiving warning letters. Similar topical anesthetic creams are compounded by the other firms, and today’s action serves as a general warning to firms that produce standardized versions of these creams.8
“Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high-potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research commenting on the December 2006 warnings.8 The FDA advised consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.8
Toxicity Threshold for “Caine” Type Drugs
I have not found instances of serious side effects involving lidocaine 4% cream (LMX4) or lidocaine 5% cream (LMX5) that have resulted in death, but this does not mean that LMX is without side effects. The threshold for toxicity of “caine” type drugs is not clear. An article discussing the use of “caine” drugs in dentistry pointed out that adverse reactions to dental anesthetic may be due to true allergy, psychogenic reaction (syncope), normal toxic overdose, or idiosyncratic toxic overdose.6
Recommendation
While the cases and facts that I have adduced do not mean that topical lidocaine should not be used to effect topical pain relief, they strongly suggest that topical lidocaine should be used with care and that its use on large areas (the back is 18% of body surface and each leg another 18%) should be approached with caution and a knowledge of potential side effects.
