Tamiflu To Get New Warning Labels

 

# 1289

 

 

It is important to remember that no drug is 100% safe. 

 

A medication that is 99.999% safe, if given to a million people, would produce 10 cases with unwanted side effects.  Give that drug to 100 million people, and suddenly you have 1,000 people with potentially serious side effects.

 

This is the dilemma with all drugs.  Manufacturers and doctors must weigh their benefits against their risks. 

 

After reports, mostly from Japan, of suspicious neurological side-effects from teenagers taking Tamiflu, new warning labels are being recommended by the FDA.

 

 

FDA: Flu Drugs Affecting Kids' Behavior

11:36 PM PST, November 23, 2007

WASHINGTON -- Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.


 

The Food and Drug Administration on Friday released its safety review of Roche's Tamiflu and Glaxo's Relenza. Next week, an outside group of pediatric experts is scheduled to review the safety of several such drugs when used in children.

 

FDA began reviewing Tamiflu's safety in 2005 after receiving reports of children experiencing neurological problems, including hallucinations and convulsions.

 

Twenty-five patients under age 21 have died while taking the drug, most of them in Japan. Five deaths resulted from children "falling from windows or balconies or running into traffic."

 

There have been no child deaths connected with Relenza, but regulators said children taking the drug have shown similar neurological problems.

Related Post:

Widget by [ Iptek-4u ]