The FDA has approved revised boxed warnings and safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. ESAs are a bio-engineered version of a protein made in the kidneys that stimulates bone marrow to produce more red blood cells.
A sampling of the new statements addresses the following:
Merck’s Gardasil vaccine is now indicated for the prevention of genital warts (condyloma acuminata) caused by human papillomavirus (HPV) types 6 and 11 in boys and men 9 through 26 years of age. Gardasil is currently approved for use in girls and women 9 through 26 years of age for preventing cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types and 11.
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