THE FLU: FDA Cautions Doctors about Relenza, Tamiflu

      The FDA is warning doctors not to rely too heavily on the two new influenza drugs, Relenza and Tamiflu, in a year when the flu season arrived much earlier than usual and death rates from pneumonia and other flu-related illnesses have increased, the New York Times reports. Dr. Heidi Jolson, director of the FDA's division of antiviral drug products, said that "with intense media attention focusing on two heavily advertised drugs [Relenza and Tamiflu] in a flu season that is particularly severe, the agency felt compelled to issue guidance to doctors about how best to use the new drugs and two older drugs, amantadine and rimantadine" (Stolberg, 1/13). Jolson added, "We want to make certain that physicians aren't' thinking of these drugs before they would think to use antibiotics" (Neergaard, AP/Contra Costa Times, 1/13). The New York Times reports that doctors have written 300,000 prescriptions for Relenza this flu season. Precise numbers for Tamiflu were not available. While both Relenza and Tamiflu are recommended for patients with uncomplicated flu cases, FDA officials said they believed some doctors were prescribing the drugs to patients with complicated cases. Two patients died after they were prescribed Relenza when both should have received antibiotics for their bacterial infections. Another patient who should have been prescribed an antibiotic received Tamiflu, but recovered. The FDA also warned doctors that prescribing Relenza, an inhaled medication, might be risky for patients who have severe asthma or other breathing disorders, as studies have demonstrated that such patients experienced a shutting down of their airways after inhaling the drug. Although Relenza's warning label instructs doctors to exhibit caution in regard to this complication, the FDA said it has received "reports of respiratory problems following inhalation of Relenza" (1/13).

Do They Even Work?
      For either Relenza or Tamiflu to work, they must be taken within the first 48 hours of flu symptoms. Even then, they only reduce flu symptoms by about a day. Jolson said, "If they are used, it should be with a realistic expectation of the likely benefit from the drugs, which I would characterize as modest" (AP/Contra Costa Times, 1/13). Because of the drugs' results, an FDA advisory panel "was less than enthusiastic when it considered an application for approval of Relenza," voting 13-4 for the FDA to reject it. However, the agency approved Relenza. The only way to prevent influenza remains vaccination, the FDA warned (New York Times, 1/13). The agency also revealed that in November, "it had ordered Relenza manufacturer Glaxo Wellcome to stop airing misleading television ads implying the drug is more effective than it really is" (AP/Contra Costa Times, 1/13).