Safety Data

LIDODERM has a favorable safety profile with more than a decade of use.

LIDODERM (lidocaine patch 5%) is generally well tolerated when used appropriately

  • Low risk of drug-drug interactions; in clinical trials, patients used concomitant analgesics1,2
  • Nonnarcotic, nonsedating, nonscheduled, lack of complete sensory block3
  • During or immediately after LIDODERM treatment, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Other reactions may include dizziness, headache and nausea.3

No serious adverse events and no withdrawals due to adverse events in 2 pivotal clinical trials (N=67)1-3

  • In clinical trials, there was no significant difference in adverse events between LIDODERM and placebo
  • May be used in patients who have comorbidities or are taking concomitant medications
  • Use with caution in patients with severe hepatic impairment and in patients taking Class 1 antiarrhythimics
  • When LIDODERM is used concomitantly with local anesthetic products, the amount absorbed from all formulations must be considered

Systemic adverse events are unlikely because very little lidocaine is absorbed into the bloodstream—even with 3 patches daily3,4



Long-term use

  • After 7 years, patients continued to use LIDODERM in a compassionate-use program (N=20)5,b

a Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally. LIDODERM should be used with caution in patients receiving class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. LIDODERM should also be used with caution in pregnant (including labor and delivery) or nursing mothers.

b A 2-page questionnaire was completed by participants (N=20) of randomized, double-blind, placebo-controlled LIDODERM studies to assess effectiveness and patient satisfaction with long-term treatment. Age of respondents was 75 years; PHN duration, 11.7 years; and patch usage, 7.6 years (means). Patients used LIDODERM alone or in combination with other analgesics. Survey items were rated on an 11-point scale ranging from –5=extremely dissatisfied to +5=extremely satisfied.


References

  1. Galer BS, Rowbotham MC, Perander J, Friedman E. Topical lidocaine patch relieves postherpetic neuralgia more effectively than a vehicle topical patch: results of an enriched enrollment study. Pain. 1999;80(3):533-538.
  2. Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996;65(1):39-44.
  3. Lidoderm Prescribing Information. Chadds Ford, PA: Endo Pharmaceuticals Inc; 2010.
  4. Data on file. e, DOF-LD-03, Endo Pharmaceuticals Inc.
  5. Galer BS, Gammaitoni AR. More than 7 years of consistent neuropathic pain relief in geriatric patients. Arch Intern Med. 2003;163(5):628.