The Journal of allergy and clinical immunology
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In the past years, several drugs commonly used by allergy specialists have received a "black box" warning added to their package insert at the direction of the Food and Drug Administration (FDA). A "black box" warning is the highest level of 5 possible warning categories found in the package insert. The FDA has never articulated the basis for "black box" warnings. ⋯ Although the addition of a "black box" warning was recommended by the FDA Pediatric Advisory Committee for these 2 topical agents, the FDA has not yet implemented this warning. Informed consent principles require that a patient be adequately informed of the risks (among other components) of any recommended treatment. The risks, as described, of the long-acting beta-agonists and topical immunosuppressants should be presented to the patients to aid them in deciding whether they are willing to take these drugs when recommended by their physician.
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J. Allergy Clin. Immunol. · Jan 2006
Pulmonary T(H)2 response in Pseudomonas aeruginosa-infected patients with cystic fibrosis.
Pseudomonas aeruginosa infection determines the course of cystic fibrosis (CF) lung disease. Studies in human peripheral blood indicate that P aeruginosa infection is associated with a predominant T(H)2 immune response, whereas T(H)1 responses are accompanied by a better pulmonary outcome. ⋯ These results reveal the prevalence of a pulmonary T(H)2 immune response in P aeruginosa-infected patients with CF. The modulation of the pulmonary T(H)2 response in P aeruginosa infection may be an option for the treatment of P aeruginosa lung disease in patients with CF.