Over-the-counter and prescription skin numbing products can be deadly

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tube-ointmentIf misused, skin numbing products such gels and ointments containing lidocaine, benzocaine or other topical anesthetics can have “serious and life-threatening” effects, the U.S. Food and Drug Administration FDA said in a Public Health Advisory issued today.

The active ingredients from these products can enter the bloodstream and cause such serious side effects as “irregular heartbeat, seizures, breathing difficulties, coma, or even death,” the FDA warns.

“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,” the FDA said.

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
  • 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,” the advisory warns

The FDA also cautioned physicians about their use of such topical anesthetics particularly about their use during mammography.FDA Public Health Advisory:

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.

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2 thoughts on “Over-the-counter and prescription skin numbing products can be deadly

  1. Tara

    Do you have any research on a pregnancy and lidocaine injections and if it can effect the fetus. Lidocaine used for mole removals? It is very important. Please send me any research you have on this.

    1. LocalHealthGuide Post author

      Hi Tara,

      The U.S. Food and Drug Administration places injectable lidocaine in “Pregnancy Category B”.

      That means that animal studies have not found that injectable lidocaine causes harm to the fetus, but that no adequate studies have been done in pregnant women.

      Animal studies, the FDA notes, do not necessarily predict what would happen in humans.

      But it important to keep in mind that most drugs are not tested in pregnant women because it would be considered unethical to conduct such experiments, since you would not know the risk to the fetus.

      For that reason, regulators usually rely on animal studies.

      The FDA notes in that in rat studies doses up to 6.6 times the human dose have found no evidence of harm to the fetus.

      That said, because lidocaine is a category B drug, physicians are advised: “General consideration should be given to this fact before administering lidocaine HCl to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.”

      LocalHealthGuide does not give out medical advice, so the best course is to speak with your healthcare provider about your concerns.

      Here is the text from the FDA label for lidocaine:

      Pregnancy

      Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine HCl. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine HCl to women 8 of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

      Here is the link to the full document on the FDA Web site: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf

      Hope this is helpful.

      LocalHealthGuide

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