Tag Archive for ‘FDA’
The FDA has approved a fifth vaccine for 2009 H1N1 influenza for use in adults. GlaxoSmithKline says it expects to begin shipments in December.
Two patients with oseltamivir-resistant H1N1 in Scotland have fully recovered. (11/16, The Times, London) Dr. Margaret Hamburg last week defended the FDA’s decision to not use adjuvanted H1N1 vaccines. (11/12, Reuters)
Reports on 2009 H1N1 influenza in the U.S. will now use estimates from the CDC’s Emerging Infection Program, rather than counting only laboratory-confirmed cases, according to a CDC news briefing.
China’s quarantines and medical detentions may have helped slow H1N1′s spread there. (11/12, NYT) Following low earlier demand, New York City this weekend will open up its vaccine clinics to a broader population. (11/12, NYT) About 4,000 Americans have died of H1N1 since the disease emerged in April. This new estimate was made from both lab-confirmed H1N1 cases and “deaths that [...]
On Nov. 5 the federal government ordered, on an emergency basis, 10,000 treatment courses of peramivir for its national stockpile. (NYT, 11/6) The FDA has identified 140 different products sold online that purport to treat H1N1. As a result, the agency has sent letters to 75 manufacturers for federal law violation. (NYT, 11/6) Some of [...]
PERSPECTIVE The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza D. Birnkrant and E. Cox On October 23 the FDA issued an Emergency Use Authorization for peramivir for the treatment of suspected or confirmed cases of 2009 H1N1 influenza. Drs. Debra Birnkrant and Edward Cox discuss the limited data on safety and [...]
Ventilator obstruction was blamed for the death of a woman who received zanamivir inhalation powder that was solubilized and administered by mechanical ventilation. (more…)
President Obama declared over the weekend that the 2009 H1N1 pandemic constitutes a national emergency.
CORRESPONDENCE Use of Ribavirin to Treat Influenza K.M. Chan-Tack, J.S. Murray, and D.B. Birnkrant With the current H1N1 influenza pandemic, questions have arisen regarding the potential for ribavirin as a treatment option. These authors report that the published studies are inconclusive regarding the potential clinical benefits of the drug for the treatment of influenza. Full [...]
The FDA has approved Fluarix, an inactivated seasonal influenza vaccine, for use in children ages 3 to 17 years. The vaccine was previously approved for adults.