The Food and Drug Administration FDA approved the use of Relenza (zanamivir for inhalation) for prevention (prophylaxis) of influenza (flu) in adults and children 5 years of age and older. Tamiflu (oseltamivir phosphate) previously was approved for both prevention and treatment of flu; today's approval of Relenza for prevention provides Americans with another option for the prevention of influenza A and B infections.
Breathing problems (bronchospasm), including deaths, were reported in some patients after the initial approval of Relenza. Most of these patients had asthma or chronic obstructive pulmonary disease. Relenza therefore is not recommended for treatment or prophylaxis of seasonal influenza in individuals with underlying airways disease such as asthma or chronic obstructive pulmonary disease.
Relenza has not been proven effective for treatment of influenza in people with underlying airways disease, or for prevention of influenza in nursing homes. The drug is also not a substitute for the flu vaccine, which is the primary means for preventing influenza. Consumers should continue receiving an annual flu vaccination according to guidelines on immunization practices. In preparation for a potential pandemic, FDA has assembled an agency-wide Pandemic Influenza Preparedness Task Force to provide policy leadership and strategic planning on pandemic influenza.
FDA also is working with the pharmaceutical industry to make available appropriate products and ensure that mechanisms are in place to collect the necessary efficacy and safety information. Both Relenza and Tamiflu have been identified for stockpiling.
Source:FDA
No Comments/Trackbacks for this post yet...