A public Health Advisory has been issued by the Food and Drug Administration, regarding the use of Lindane Lotion and Lindane Shampoo for the treatment of scabies and head lice. It has been taken into attention that the Medication Guide should be distributed directly to patients. Those products should contain warnings regarding the most important information of these products of use, misuse and potential risks. Boxed warnings should highlight the most important issues and should inform both the patient and the healthcare professionals(doctors) about risks and adverse reactions.



Lindane has been indicated as a second line therapy in scabies and lice. If other therapies have failed or are not tolerated, patients are advised to use Lindane because although has high toxicity, it may prove its benefits. Food and Drug Administration made a report that warn the users of Lindane not to administrate it in little children, and has contraindication in premature infants, because half of the patients with weight under 110 pounds (50 kilograms) presented adverse reactions. Scabies and head lice occur most in school age children and in US there are lots of cases every year and used Lindane in their treatment.

The explication for its high toxicity is that being absorbed through the skin in the blood in younger children has a higher level because the children have more skin surface area per pound of body weight than adults. Younger animals used in studies seem to be more susceptible to the neurological side effects of Lindane.

Patients do not follow the exact manner of use recommended on the product labeling so they misuse and overuse Lindane Lotion and Lindane Shampoo. A measure to prevent the misuse of Lindane Lotion and Lindane Shampoo has been applied to each package to be limited to 1 and 2 ounces. The Medication Guide is recommended by law to each patient and to pharmacists in order to prevent any adverse events or Lindane Lotion and Lindane Shampoo.

Patients, such as those with HIV infection, immunocompromised or patients on medications, such as antidepressants, have increased chances of adverse reactions after using Lindane products. Any changes in the labeling is important to be mentioned to Food and Drug Administration.

Because some patients are at higher risk than others, the health care providers and the doctors should prescribe Lindane Lotion or Lindane Shampoo with more care and taking into consideration adverse drug events and the safety of the treatment with Lindane Lotion and Lindane Shampoo. Significant updates to the labeling of Lindane products atre added, they include additional warnings in the topical use of Lindane Lotion and Lindane Shampoo in the treatment of scabies and head lice.