FDA Actions

FDA Actions

The FDA has authorized emergency use of IV antiviral peramivir for treatment of 2009 H1N1 influenza in hospitalized patients. The drug is not yet approved for use in this country, but was authorized in response to a request from the CDC. IV peramivir is approved only for hospitalized adult and pediatric patients for whom an IV drug is clinically appropriate because the patient is not responding to either oral or inhaled antiviral therapy, because enteral or respiratory therapy is not feasible, or in adults when a clinician judges that IV therapy is appropriate due to other circumstances. This is the first available IV antiviral available for 2009 H1N1 infections. For more information see www.cdc.gov/h1n1flu/eua/.

The FDA has approved the quadrivalent human papilloma virus (HPV) vaccine (Gardasil^®) for use in boys and young men. The vaccine is approved for males ages 9-26 as 3 injections given over a 3- month period. HPV is the most common sexually transmitted disease in the United States with 1 of 500 men infected every year. Previously, the vaccine had only been approved for use in females ages 9-26 years. In related news, a recent study from the National Cancer Institute, CDC, and American Cancer Society has suggested that the vaccine is not cost-effective for women older than age 30 who undergo annual or biennial screening for cervical cancer (Ann Intern Med 2009;151:538-545). Similarly, a study from Harvard found that HPV vaccination for 12-year-old girls was cost-effective, but the same vaccination for 12-year-old boys was not (BMJ 2009 Oct. 8).

The FDA has also approved a bivalent HPV vaccine for use in females, which protects against HPV types 16 and 18. The vaccine is being marketed as a "cervical cancer vaccine" by Glaxo-SmithKline under the trade name Cevarix^®.