Lindane Product Advancements
Prescription Lindane Labeling
The professional product labeling for lindane medications (also referred to as “full prescribing information”) provides physicians and other healthcare providers with important information on the benefits, risks, and appropriate use of these lindane prescription therapies. Over the past three decades, the prescription labeling for lindane lotion and lindane shampoo has been updated for safety as new information has become available and reviewed by the Food and Drug Administration (FDA). (See Lindane Regulatory History) These updates, implemented by the U.S. manufacturer, help to maximize the safety of lindane medications in healthcare practice.
Recent changes in lindane prescription labeling improve the benefit-safety balance of lindane medications
In 2003, a boxed warning was added to lindane professional labeling to raise awareness among healthcare professionals of the potential risks for neurologic toxicity and proper use of lindane medications for the treatment of scabies and lice, including:1
- Second-line use, for patients who have failed or who cannot tolerate approved first-line medications
- Risk of neurologic toxicity, particularly with product misuse, and risks in infants, children, the elderly, individuals with other skin conditions, and patients weighing <110 lbs. (label suggests using lindane only with caution in these groups of patients) (See Adverse Events)
- Contraindications in premature infants and persons with seizure history (label suggests never using lindane in these patients)
- Proper use instructions, including how much lindane medication should be applied and how long it should be left on
The exact language in the current boxed warning for lindane lotion is shown below. Similar language is also contained in the boxed warning for lindane shampoo.2,3
WARNINGS:
Lindane lotion should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies (See INDICATIONS AND USAGE.)
Neurologic Toxicity
Seizures and deaths have been reported following lindane lotion use with repeat or prolonged application, but also in rare cases following a single application used according to directions. Lindane lotion should be used with caution in infants, children, the elderly, and individuals with other skin conditions (e.g., atopic dermatitis, psoriasis) and in those who weigh <110 lbs (50 kg) as they may be at risk of serious neurotoxicity
Contraindications
Lindane lotion use is contraindicated in premature infants and individuals with known uncontrolled seizure disorders
Proper Use
Instruct patients on the proper use of lindane lotion, the amount to apply, how long to leave it on, and avoiding re-treatment. Inform patients that itching occurs after the successful killing of scabies and is not necessarily an indication for re-treatment with lindane lotion (See DOSAGE AND ADMINISTRATION.)
Professional labeling of U.S. lindane products promotes safety
| Lindane products | U.S.2–4 | Canada5 |
|---|---|---|
| Regulatory status | Prescription only | O.T.C.* , no prescription required |
| Professional product labeling | Reviewed and updated in close collaboration with the FDA; provides detailed scientific information and clinical guidance specifically for healthcare professionals | Due to O.T.C.* status, no professional labeling is required; package insert contains only information for patients, who may be unaware of the importance of consulting with a physician, nurse, or pharmacist |
* O.T.C.=over-the-counter medication
Please See Important Safety Information on Lindane
References:
- U.S. Food and Drug Administration (FDA). Public health advisory: Safety of topical lindane products for the treatment of scabies and lice. March 28, 2003. Available at: http://www.fda.gov/cder/drug/infopage/lindane/lindanePHA.htm.
- Lindane lotion, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309lotionlbl.pdf.
- Lindane shampoo, USP, 1% prescribing information. Updated March 28, 2003. Available at: http://www.fda.gov/cder/foi/label/2003/006309shampoolbl.pdf.
- U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER) Report to the Nation: 2003. Available at: http://www.fda.gov/cder/reports/rtn/2003/rtn2003-3.htm.
- Lindane Canadian package insert: Lindane Shampoo and Lotion. Pharmascience, Inc., Montréal, Canada.