Health

Relenza Under Question

By CBSNews.com staff CBSNews.com staff

January 31, 2002 / 8:41 AM EST / CBS

This could be a make-or-break season for Relenza, with contradictory reports showing that the flu drug either causes severe breathing problems or helps improve poor lung function. CBS Correspondent Sharyl Attkisson has the exclusive "Eye on America" report.

In the next few months, the Food and Drug Administration (FDA) plans to carefully monitor adverse events related to Relenza. Although the drug has only been in the market for less than 2 years, government officials have already recorded 23 deaths that may be related to its use. No conclusive link between the fatalities and the drug have been shown, but officials say they will still carefully watch the medicine over the next few months.

CBS News has obtained information about some of the cases in the FDA adverse events reports. "Immediately following his first dose," reads one report, "the patient's [breathing trouble] worsened. On the third day...the problem was so bad, it was considered 'life-threatening.'"

The patient's doctor and pharmacist wrote about the case in the New England Journal of Medicine. The researchers say they decided to write about the topic because there's so little literature on the issue, and doctors don't always have time to read drug warning labels.

In the past year, GlaxoSmithKline, Relenza's maker, agreed to issue a stronger label for the drug because of serious adverse events, and sent a special warning letter to doctors.

Now, however, the company says Relenza could actually be good for those with breathing trouble, the population of patients the FDA considers at most risk.

Kevin Murphy, MD, of the Midwest Allergy and Asthma clinic, conducted a recent study on asthma patients for GlaxoSmithKline. "We have not seen problems with the drug," he says. "Those patients who were treated with Relenza actually had improvement of lung function during the first 5 days of therapy compared with those who received no treatment."

Consumer advocate Sidney Wolfe, MD, still insists Relenza should never have been put on the market in the first place because, he says, it's never been proven to work. "This drug was found to be so ineffective that the advisory committee that looked at the data voted 13-4 not to [approve] the drug... and yet they were overruled because of pressure from the company and other people higher up in the FDA."

FDA officials say they approved Relenza, because even a small benefit could be very important.