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FDA BLACK BOX WARNING Lindane Shampoo should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of lice. 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. Neurologic Toxicity Seizures and deaths have been reported following Lindane Shampoo or Lotion use with repeat or prolonged application, but also in... |
FDA BLACK BOX WARNING Lindane Shampoo should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of lice. 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. Neurologic Toxicity Seizures and deaths have been reported following Lindane Shampoo or Lotion use with repeat or prolonged application, but also in rare cases following a single application according to directions. Lindane Shampoo or Lotion should be used with caution in infants, children, the elderly, and individuals with other skin conditions, and those who weigh less than 110 lbs (50 kg) as they may be at risk of serious neurotoxicity. Contraindications Lindane Shampoo or Lotion is contraindicated in premature infants and individuals with known uncontrolled seizure disorders. Proper Use Instruct patients on proper use of Lindane Shampoo or 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 lice or scabies and is not necessarily an indication for retreatment with Lindane Shampoo or Lotion. |
Public Citizen has been warning for years that Lindane — a medication to get rid of lice or scabies — is dangerous and should be taken off the market. Lindane is a pesticide similar to DDT (which is banned), and it makes no sense to put such a powerful toxin on your skin when it poses a risk of cancer and other serious illnesses.
While the FDA has kept Lindane on the market, it has required a black-box warning and other special safeguards for the drug. Now, the Centers for Disease Control and Prevention (CDC) have given another good reason to ban Lindane: a study indicates that the dangerous lotion or shampoo is often ingested orally, poisoning the people who swallow it without realizing the mistake they are making.
The CDC reported on June 3, 2005 on the accidental oral intake of Lindane Lotion and Shampoo, products that are intended to be used only on the skin and as a shampoo to treat lice or scabies. In 2004, CDC was alerted to cases of illness caused by unintentional ingestion of Lindane by persons mistaking the product for a liquid oral medication, such as cough syrup.
The CDC, with assistance from the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and state health departments, collected case reports from around the country to assess the extent of illness cause by the accidental ingestion of Lindane. The assessment found 870 cases of unintentional Lindane ingestions from 1998 through 2003. This estimate is likely low due to the number of cases that are not reported. The ingestions resulted in vomiting, nausea, oral irritation, abdominal cramping, cough, and seizure. No deaths were reported.
In 1983, and again in 1995, Public Citizen petitioned the FDA to ban Lindane. Years later, the FDA finally strengthened the safety labeling warning for Lindane.
In March 2003, the FDA issued a public health advisory about Lindane. The agency announced that a black-box warning would be required on the professional product labeling of the drug. A black-box warning is the strongest type of warning that the FDA can request on a drug’s professional labeling. Also, pharmacists would be required to distribute a Medication Guide, written specifically for patients, with each Lindane prescription. At this time, only drugs that pose serious public health concerns are required to be dispensed with a Medication Guide.
Lindane is a pesticide of the organochlorine type, in the same group as DDT. Although the EPA drastically cut the amount of Lindane used in industry and agriculture, this toxin is still available. Workers exposed to Lindane over the long term may eventually develop damage to their bone marrow, kidneys, liver, or reproductive organs. Lindane is classified as a carcinogen. Even individuals who use Lindane briefly for lice or scabies, as well as people whose work exposes them to Lindane, can experience rashes, dizziness, or convulsions. Vomiting, muscle cramps, nervousness, unsteadiness, and fast heartbeat have also been reported.
In September 2004, the North American Task Force on Lindane drafted an action plan for future use. On January 1, 2005, Canada withdrew registration of Lindane for agricultural pest control; Mexico is working on a plan to phase out all uses of Lindane. However, with the exception of California, which banned Lindane for medicinal use on January 1, 2002, U.S. representatives to the North American Commission for Environmental Cooperation announced that the U.S. will continue to allow use of Lindane as both a pesticide and pharmaceutical.
There is no medical reason for Lindane to remain on the market. There are two over-the-counter FDA approved treatments for lice and scabies: pyrethrin/piperonyl butoxide (RID) and permethrin (NIX). Malathion (OVIDE) is available as a prescription-only drug.
What You Can Do
There is no reason why you should use Lindane Lotion or Shampoo when safer and equally effective treatments for lice and scabies are available.
You should also be extremely careful in the way that you store prescription and over-the-counter lotions and shampoos so that they are not confused with oral medications.
