FDA Recommends Stronger Warning Label For Tamiflu

Personally, I’ve never been prescribed medication for a bout of the flu – I’ve always just ridden it out with a sick day on the couch, armed with Saltines, Ginger Ale and Tivoed Oprah. But many people – particularly those in Japan, where doctors usually prescribe drugs to treat flu symptoms – do take prescription drugs for the flu. And most of them are taking Tamiflu – the most widely prescribed drug for influenza in the world.

But a panel of experts at the FDA has recommended a stronger warning label for Tamiflu, citing some frightening psychiatric side effects experienced by a handful of patients - including delirium and self-injury. The label currently mentions these potential problems, but some of the experts think the label needs to specify that several have died as a result of these behaviors. Others on the panel, though, thought the label should also point out that similar deaths have occurred in patients with the flu who were not on Tamiflu or other flu medication.

Almost 600 psychiatric cases have been reported from patients taking Tamiflu, and five children in Japan died from falling from windows or running into traffic after taking the drug. 75% of the reported psychiatric cases from those taking Tamiflu have come from Japan.

Roche, the drug maker, presented their own study on Tuesday, saying that there is not link between Tamiful and psychiatric problems and that data shows that these issues are increasingly linked to the flu itself, not the medication.

Many Americans think of the flu as an unpleasant annoyance – often a 24-hour bug that’s not a barrel of laughs, but not really harmful, either – but whether these severe psychiatric issues are a result of the flu itself or drugs like Tamiflu that treat it, it’s important to be aware of potential problems as flu season gets underway.

Here’s the full article at the New York Times:

http://www.nytimes.com/2007/11/28/health/policy/28fda.html?ref=health

 

 

Comments

[Tamiflu Prescription Information]

My name is Mike Conlin and i would like to show you my personal experience with Tamiflu.

I am 26 years old. Have been on Tamiflu for 5 days now. This stuff ROCKS. I was running a 104 Fever ... felt like I was doing to die, was snapping at everyone, etc. I got home and took my first dose along with a dose of Robotussin for my cough. I woke up 3 hours later and my fever dropped from 103.7 to 99.3. It fluctuated a little after that but remained under 100. Body Aches were gone. I was sweating like a mad man but that was probably the fever breaking.

I have experienced some of these side effects-
Mild nausea .. almost puked on first dose. Also had mental fog going on. Concentration was difficult but my doctor forwarned me it makes you 'loopy'.

I hope this information will be useful to others,
Mike Conlin

[Dan]

It is understood that the disease influenza is a disease caused by a RNA virus that can infect both mammals and birds. In fact, this particular virus can mutate to where it can be shared between the two life forms and multiply within each one of them.

Unlike coryza, influenza expresses symptoms more severely, and usually lasts two weeks until one recovers who has the flu. Influenza, however, poses a danger to some with compromised immune systems, such as the chronically ill. In cases such as this, influenza can in fact progress to deadly pneumonia. Symptoms of influenza usually start to express themselves 36 hours after being infected with the virus.

The flu vaccination contains three viral strains of suspected viruses for flu outbreaks during a particular winter season, as determined by the World Health Organization. Yet the strains chosen are speculated influenza viruses, as this does not eliminate the chance of a new and dominant influenza viral strain that possibly could cause a pandemic. It takes manufacturers about 6 months to make and formulate the influenza vaccination. We hope.

Dan Abshear