Dermatologic therapy
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The primary cutaneous T cell lymphomas (CTCL) encompass all malignancies of the T cell where the skin is the primary organ of involvement. The diagnosis of a CTCL variant can be detoured by a number of obstacles including the slow evolution of the disease into a classic clinical and pathologic pattern. ⋯ When using the systemic agents, a "start low and go slow" strategy may offer patients several advantages. Dermatologists are uniquely trained to diagnose and to manage all but the most advanced stage patients with CTCL.
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Cimex lectularius (the "bedbug") is an insect that feeds nocturnally, taking a requisite blood meal from a sleeping human or other parasitized host. Immunological reactions to bedbug saliva vary, but typically, bites yield erythematous and pruritic papules. The face and distal extremities, areas uncovered by sleeping clothes or blankets, are preferentially involved. ⋯ Although hepatitis or human immunodeficiency virus is not effectively transmitted by the bedbug, pruritus and the fear and perceived violation of an infestation can be debilitating. Bedbugs are small but robust, and their ability to remain ensconced in crevices within the bedroom makes eradication difficult. As more patients present with bedbug bites, physicians must possess the knowledge to diagnose, treat, and educate with regard to bedbug bites and bedbug infestations.
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Lepidoptera (moths, butterflies, and caterpillars) are an uncommon cause of adverse reactions in humans. Most reactions to Lepidoptera are mild and self-limited; however, reactions in sensitive individuals and reactions to particular species can be severe and life threatening. ⋯ Antipruritic or anesthetic topical preparations, topical steroids, and oral antihistamines are often used. In the case of potentially fatal Lonomia envenomation, an effective antivenin has been manufactured.
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This article discusses the history and evolution of the process for generic drug evaluation and approval in the United States, with emphasis on locally acting dermatologic products. The requirements for in vivo bioequivalence (BE) testing and the statistical criteria for BE are discussed, and an example of a topical antifungal dermatologic product is used to demonstrate the BE determination for locally acting drugs. Other factors in the dispensing of prescription medications that are not within the Food and Drug Administration regulatory authority are also mentioned.
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Dermatologic therapy · May 2009
ReviewFinding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).
Marketed pharmaceuticals are evaluated for safety by the US Food and Drug Administration (FDA) throughout the life cycle of the products. The FDA uses data from controlled clinical trials, from postmarketing case reports reported to the FDA's Adverse Event Reporting System, from epidemiological studies, and from registries to evaluate the safety of approved products. For some products, including some products used in dermatologic medicine, risks become apparent during the postmarketing period that require additional measures beyond product labeling and routine pharmacovigilance. The FDA continues to seek additional tools to assess risk, including pharmacogenomic biomarkers for adverse drug reactions and the use of large medical record and epidemiological databases for the systematic detection and characterization of drug-associated safety outcomes.