Second Drug Approved to Prevent Flu
Relenza already sanctioned to treat flu's symptoms
WEDNESDAY, March 29, 2006 (HealthDay News) -- The inhaled antiviral drug Relenza (zanamivir for inhalation) has been approved to prevent influenza in adults and children aged 5 and older, the U.S. Food and Drug Administration announced Wednesday.
GlaxoSmithKline's Relenza, already approved to treat influenza's symptoms, now joins Roche's Tamiflu as drugs approved to both treat and prevent flu, the agency said in a statement.
In a large-scale clinical study, 4.1 percent of people using Relenza went on to develop flu, compared with 19 percent who acquired flu while taking a non-medicinal placebo, the FDA said.
The agency warned that people with asthma and other lung diseases shouldn't use Relenza, as they may be at higher risk of developing a dangerous breathing problem called bronchospasm. An unspecified number of patients with chronic pulmonary disease died after initial approval of the drug, the FDA said.
The drug is not a substitute for the flu vaccine, and its effectiveness has not been tested as an influenza preventive in certain high-risk settings like nursing homes, the agency said.
Common side effects of Relenza have included headache, dizziness, nausea, nasal irritation, bronchitis, cough, and sinus infection, the FDA said.
To learn more about flu, visit the U.S. Centers for Disease Control and Prevention.