Lindane Lotion Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
(See boxed WARNINGS.)
Seizures and deaths have been reported following Lindane Lotion's use with repeat or prolonged application, but also in rare cases following a single application reportedly used according to directions. It is not known how soon after application of a single dose of Lindane Lotion that a second dose of Lindane Lotion can be safely applied.
There have been cases of adverse events reported for Lindane Lotion and Lindane Shampoo in which a serious outcome (hospitalization, disability or death) has occurred.4 In approximately 20% of the total reported cases, Lindane Lotion and Shampoo were reported to have been used according to the labeled directions. Of these cases, thirteen deaths were reported, many cases which were remote from the time of actual Lindane use. Lindane toxicity, verified by autopsy was the cause of one infant's death, was the cause of death reported for an adult who ingested it orally in a successful suicide. The direct causes of death for the other cases were attributed to reasons other than Lindane. Most of these adverse events occurred with Lindane Lotion.
Infants, children, the elderly, and individuals with other skin conditions and those who weigh < 110 lbs (50 kg) may be at greater risk of serious neurotoxicity. (See Pediatric Use and Geriatric Use.) Animal studies have shown increased susceptibility to neurologic adverse events in younger animals. Children have a larger body surface area to volume ratio that may result in a proportionately larger systemic exposure.
Careful consideration should be given before prescribing Lindane Lotion to patients with conditions that may increase the risk of seizure, such as HIV infection, history of head trauma or a prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from alcohol or sedatives, as well as concomitant use of medications known to lower seizure threshold. (See PRECAUTIONS: Drug Interactions.)
Patients should be instructed on proper use of Lindane Lotion, especially the amount to apply, how long to leave the lotion on, and the need to avoid retreatment. Patients should be informed that itching may occur, and even worsen, after the successful killing of scabies. Repeat treatment is usually not necessary.
A Lindane Lotion Medication Guide must be given to the patient each time Lindane Lotion is dispensed, as required by law.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Lindane Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei ) only in patients who:
- cannot tolerate other approved therapies, or
- have failed treatment with other approved therapies.
Lindane Lotion should be used in the context of an overall scabies management program that includes:
- Microscopic evaluation of skin scrapings to confirm the diagnosis.
- Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Lotion only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
- Washing of all recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels in very hot water or dry-cleaned.
Caregivers applying this product to patients should wear gloves less permeable to Lindane, such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Lindane.
Lindane Lotion does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.
There is currently no drug history available for this drug.
Lindane Lotion USP, 1%, is an ectoparasiticide and ovicide. In addition to the active ingredient, lindane, it contains 2-amino-2-methyl-1-propanol, butylparaben, carrageenan, cetyl alcohol, glyceryl monostearate, methylparaben, perfume compound, purified water, stearic acid and triethanolamine to form a lotion. The pH range is between 6.5 and 8.5. Lindane is the gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane having the following structural formula:
C6H6Cl6 M.W. 290.83