View Full Version : New Warnings for Flu Drugs

11-23-2007, 12:24 PM
FDA Staff Urge Psych Warnings for Two Flu Drugs

WASHINGTON (Reuters) - U.S. Food and Drug Administration staff are recommending new warnings about psychiatric events observed in some patients taking Roche Holding AG's Tamiflu and GlaxoSmithKline Plc's Relenza, according to documents released on Friday.

An FDA advisory panel will discuss recommendations for the anti-viral influenza drugs at a meeting next week.

The FDA held a similar meeting two years ago amid reports of a dozen deaths of children in Japan taking Tamiflu. Experts then were unable to find a direct connection between the drug and the deaths, although the FDA did ultimately update Tamiflu's label to add a caution urging close monitoring of patients for abnormal behavior such as delirium or self-injury.

In documents prepared for the meeting next week and posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened to note, "in some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behavior" observed in some patients taking the drug.

FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

Tamiflu, known generically as oseltamivir, is a pill, while Relenza, generically zanamivir, is inhaled.

A Roche spokesman said no causal relationship between Tamiflu and these psychiatric events has been proven.

"Roche has extensively investigated the issue and is conducting ongoing clinical and nonclinical studies. Roche takes all adverse events reports very seriously," spokesman Terence Hurley said in a statement.

About 48 million people have taken Tamiflu worldwide, including 21 million kids, since approval in 1999, he said.

A Glaxo spokeswoman said a review of premarketing and post-approval trial data showed no signal of these types of adverse events on patients taking Relenza.

FDA staff reviewed nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

The documents for advisory meeting were posted at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b-00-in dex-27and28.html .

(Additional reporting by Ben Hirschler in London)

(Reporting by Kim Dixon; Editing by Tim Dobbyn)

FDA Flu Drug Warnings (http://news.yahoo.com/s/nm/20071123/us_nm/fda_fludrugs_dc)

11-24-2007, 10:27 PM
I heard about that.

I have to wonder about the wisdom of actually announcing what it can do.

How much you all wanna bet that some people are going to go buy a bunch of it just to "see if it is true?"

11-27-2007, 02:55 PM
I can't take the stuff because of my heart. Makes you wonder how safe the stuff is actually.