Lindane. The U sustenance and Drug...

Lindane. The U sustenance and Drug Administration (FDA) has issued a Public Health Advisory concerning the use of topical formulations of Lindane Lotion and Lindane Shampoo for the treatment of scabies and lice.

Labeling for Lindane yields has been changed to include a driver's seated warning that highlights the chiefly important safety issues associated with use of these proceedss The boxed warning contains information to better inform physicians and patients regarding the potential risks associated with the use and misuse of Lindane.

The warning emphasizes that Lindane effects have been, and continue to be, indicated as a second-line therapy for the treatment of scabies and lice. While the FDA believes that the benefits of Lindane outweigh the risks when used as directed, given the potential for neurotoxicity, patients should barely be treated with these medications if other treatments are not tolerable or other approved therapies have failed.

The just discovered boxed warning also states that Lindane Lotion and Lindane Shampoo are to be used with caution in patients who weigh les than approximately 110 lb These works are not recommended for use in infants and are contraindicated in premature infants. These warnings are based forward reports to the FDA's voluntary reporting theory which described approximately one half of reported adverse incidents occurring in pediatric patients.

It is estimated that in the United States up to 1 million prescriptions are written each year to treat of recent origin cases of head lice and scabies, which happen mostly in school-aged children. Because Lindane is absorbed from one side the skin, and because younger children have more skin surface area through pound of body weight than adults, the amount that is absorbed may rise in higher blood levels of Lindane in children than that seen in adults. Animal studies also have shown that younger animals are more susceptible to the neurologic side powers seen with Lindane use.

Because mostly of the serious adverse affairs reported with Lindane products are caused at misuse and overuse, especially with the lotion, fruits package sizes will be limited to 1 and 2 oz Patients should understand the importance of using this medication in a manner consistent with the consequence labeling.

The instructions for use and information about adverse results also will be provided to patients in the form of a Medication Guide. by way of law, the Medication Guide must be dispensed on pharmacists directly to the patient with each novel prescription of Lindane Lotion or Lindane Shampoo.

Other changes in the labeling address FDA be of importance tos about potential increased risk of adverse reactions associated with the use of Lindane fruits in immunocompromised patients, such as those with human immunodeficiency virus infection, or patients taking medications, of the like kind as antidepressants, that may increase the chances of having a seizure.

Permethrin 5 percent cream is attract favor toed by the Centers for Disease repress and Prevention as primary therapy for scabies. Given the possible risks associated with the use of Lindane, physicians should consider this modern safety information when deciding whether to prescribe Lindane Lotion or Lindane Shampoo for patients who may be at risk of serious adverse physic events.

COPYRIGHT 2003 American Academy of Family Physicians

COPYRIGHT 2003 Gale Group