The two most common drugs used to treat and prevent the flu may have been a factor in the deaths of 25 children worldwide and caused bizarre psychiatric side effects, the Food and Drug Administration said yesterday after two years of reviewing the drugs.
Roche's Tamiflu and Glaxo's Relenza have caused hallucinations and mania in 365 children, mostly in Japan, since 1999, the FDA said.
Many of the cases involved children trying to "flee or escape" and fatally "falling from windows or balconies or running into traffic," the FDA said.
One child on Tamiflu tried to strangle his mother, while others banged their heads against walls.
In Japan, three adults on the medication committed suicide in addition to the five children who died.
"Although there is still uncertainty about the cause of the reported abnormal behavior in patients," the FDA wrote in the report posted on its Web site, it is "prudent" to add warnings to the drug's labeling to warn of the possible side effects.
The FDA has not ordered the drugs to be pulled from pharmacies, but a panel will further review the drug's safety next week and could issue more recommendations at that time.
All of the 25 deaths were children taking Tamiflu, the FDA said, but children taking Relenza have suffered from similar neurological problems.
The FDA said it isn't clear whether the problems are related to the drugs, the flu, or a combination of both. They said the strange behaviors and deaths may come from an unusual strain of the flu or a rare genetic reaction to the drug.
Roche, based in Basel, Switzerland, says studies show the flu, not the drug, causes the reported side effects.
Tamiflu's prescribing information was updated last year to tell doctors they should monitor patients for signs of abnormal behavior.
Governments worldwide have been stockpiling the drugs in case of an epidemic like avian flu, which has made the medications cash cows for the their respective companies.
Tamiflu has proven effective in fighting avian flu in scientific tests on ferrets. A course of Tamiflu consists of 10 doses administered over five days.
The demand for Tamiflu was so high that more than 200 companies and governments expressed an interest in helping with the manufacture of Tamiflu to meet the need.
President Bush proposed stockpiling enough Tamiflu for 81 million people.
Tamiflu, Roche's ninth-best-selling drug, generated $257 million in the third quarter of 2007. Relenza generated $58 million for Glaxo in the third quarter.
But both companies have reported significant drops in sales since controversy over the drugs began. Sales of Tamiflu have dropped 62 percent since 2006. With Post Wire Services
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