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Goods and Bads of Scabies Medication

Article Summary: The Food and Drug Administration (FDA) issued a Notice of Public Health concerning the use of topical formulations of Lindane lotion and lindane shampoo for the treatment of scabies and lice.

The Food and Drug Administration (FDA) issued a Notice of Public Health concerning the use of topical formulations of Lindane lotion and lindane shampoo for the treatment of scabies and lice. The board provides significant updates to the labeling of these products. These labeling changes include additional warnings and the addition of a guide to medicines to be distributed directly to patients.

Product labeling for lindane has been modified to include a box warning that highlights the most important safety issues associated with use of these products. The box contains information warning to better inform both health professionals and patients regarding the potential risks associated with the use and misuse of Lindane.

The warning emphasizes that the lindane products were, and continue to be listed as second-line treatment for the treatment of scabies and lice. Although FDA believes that the benefits of Lindane outweigh the risks when used as directed, given the potential for neurotoxicity, patients should be treated with these medications if other treatments are not tolerable or other therapies have failed.

The new box warning also states that Lindane lotion and lindane shampoo should be used with caution in patients who weigh less than about 110 pounds (50 kilograms). These products are not recommended for infants, and are contraindicated in premature infants. These warnings are based on reports to the FDA \ 'voluntary reporting system that describes about half of the adverse events reported in pediatric patients.

It is estimated that in the United States, up to 1 million prescriptions are written each year to treat new cases of head lice and scabies, which occur mostly in school-age children. Since Lindane is absorbed through the skin, and because young children have more skin surface area per pound of body weight than adults, the amount that is absorbed may result in higher levels of blood lindane in children than in adults. Animal studies have also shown that young animals are more sensitive to adverse neurological effects observed with the use of lindane.

Because most serious adverse events reported with Lindane products are due to misuse and overuse, especially with Lotion, package sizes will be limited to 1 and 2 ounces. It is very important that patients understand the importance of the use of this product in a manner consistent with product labeling.

manual and information about adverse events will also be provided to patients in the form of a guide to drugs. By law, the Guide must be dispensed by pharmacists directly to the patient with each new prescription of Lindane Lindane lotion or shampoo.

Other changes in the labeling address FDA concerns of potential increased risk of adverse reactions associated with the use of Lindane products in immuno patients, such as those with HIV infection or patients on medicines, like antidepressants, which may increase the chances of D'seizure.

Given the possible risks associated with the use of Lindane, healthcare providers should consider this new safety information when deciding whether to prescribe Lindane Lindane lotion or shampoo for patients who may be at risk of serious adverse drug events.

Article Source: http://www.upublish.info

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ebet sanders
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