"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
- Patient Information:
Details with Side Effects
Accidental Exposure in Children
Even a used LIDODERM patch contains a large amount of lidocaine (at least 665 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used LIDODERM (lidocaine patch 5%) patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of LIDODERM (lidocaine patch 5%) out of the reach of children, pets and others. (See Handling And Disposal)
Excessive dosing by applying LIDODERM (lidocaine patch 5%) to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 µg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine. With recommended dosing of LIDODERM (lidocaine patch 5%) , the average peak blood concentration is about 0.13 µg/mL, but concentrations higher than 0.25 µg/mL have been observed in some individuals.
Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally.
Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, LIDODERM (lidocaine patch 5%) should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. LIDODERM (lidocaine patch 5%) is only recommended for use on intact skin.
External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over LIDODERM (lidocaine patch 5%) patches is not recommended as this has not been evaluated and may increase plasma lidocaine levels.
Eye Exposure: The contact of LIDODERM (lidocaine patch 5%) with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis: A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of LIDODERM.
Mutagenesis: Lidocaine HCl is not mutagenic in Salmonella/mammalian microsome test nor clastogenic in chromosome aberration assay with human lymphocytes and mouse micronucleus test.
Impairment of Fertility: The effect of LIDODERM (lidocaine patch 5%) on fertility has not been studied.
Teratogenic Effects: Pregnancy Category B. LIDODERM (lidocaine patch 5%) has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, LIDODERM (lidocaine patch 5%) should be used during pregnancy only if clearly needed.
Labor and Delivery
LIDODERM has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery. Should LIDODERM be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.
LIDODERM has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk:plasma ratio of lidocaine is 0.4. Caution should be exercised when LIDODERM (lidocaine patch 5%) is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Lidoderm Information
Lidoderm - User Reviews
Lidoderm User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.