This is the article I thought may have caused a selloff seems...

This is the article I thought may have caused a selloff seems all ok and back to $1.30 now anyway.. Couple of others about similar info but this mentions psychiatric side effects and sales down. Guess we will have to wait and see if sales affected. I'll put them in the drawer for a while.

Tamiflu, Relenza Need New Warnings, U.S. Panel Says (Update3)

By Catherine Larkin

Nov. 27 (Bloomberg) -- Roche Holding AG's Tamiflu and GlaxoSmithKline Plc's Relenza, the two most common drugs used to treat the flu, should carry revised warnings about a risk of psychiatric side effects, a U.S. panel said.

The committee of outside advisers to the Food and Drug Administration decided today that prescribing information doesn't adequately explain the delirium, hallucinations and psychotic behavior reported by hundreds of patients in Japan and the U.S. since the medicines came on the market in 1999. Tamiflu added a precaution about these risks last November, and regulators have identified similar reports in Relenza patients since then.

Tamiflu sales have fallen since the FDA first raised safety concerns two years ago. The new prescribing information should say the side effects are rare and may also occur in patients with influenza who aren't taking Tamiflu or Relenza, members of the advisory panel said.

``It involves certain behaviors and activities that in either case, the public may need to be more aware of and watch more closely,'' panel member Michael Fant, an associate professor at the University of Texas-Houston Medical School, said today at a meeting in Gaithersburg, Maryland. ``Anything that elevates awareness is probably not a bad call.''

The FDA usually follows the recommendations of its advisers, though it isn't required to do so.

Roche Says It's the Flu

Roche, based in Basel, Switzerland, presented studies at the panel's meeting suggesting that the flu virus is to blame for the behaviors seen in some patients taking Tamiflu. The company said it hasn't found any evidence of a causal relationship between the drug and the psychiatric side effects.

``The committee's comments followed an extensive review of new data conducted by Roche and others,'' the company said in a statement distributed after the meeting. ``Roche has investigated the reports extensively and will continue its ongoing studies and analyses.''

Some of the panel members suggested that the companies undertake new studies to quantify the risks, instead of reviewing reports of patients who already were treated.

``I would really like to see a case-controlled study of the neuropsychiatric events,'' said Robert Ward, director of the Pediatric Pharmacology Program at the University of Utah School of Medicine. ``We need to continue in-depth evaluation of these until we understand why they're occurring.''

25 Reported Deaths

As of the end of the last flu season in May, the FDA had identified 25 reported deaths and 365 cases of abnormal behavior in children and young adults age 21 and younger who took Tamiflu since it was approved in 1999. Twenty-one of the deaths were in Japan, where the use of flu treatments is more common. Five of the youths died of traumatic injuries as a result of falls from windows or balconies or from running into traffic.

Japan's Ministry of Health, Labor and Welfare recommended in March that patients age 10 to 19 shouldn't take Tamiflu unless they have a high risk of complications from the flu. Most of the cases of abnormal behavior involving Relenza, an inhaled medicine in the same class as Tamiflu, have been reported since then.

The FDA found 115 cases of psychiatric side effects linked to Relenza, including 74 in children. Most of the reports were from Japan. There were no suicide attempts or deaths.

Each year in the U.S., an estimated 36,000 people die and 200,000 are hospitalized because of complications of the flu. Young children and the elderly are among the most vulnerable.

Sales Drop 60 Percent

Tamiflu pills and oral solution generated 257 million Swiss francs ($233 million) in the third quarter, a 60 percent drop from a year earlier as safety concerns had an effect and government demand declined. Some nations stockpile the drug for use in case of a pandemic flu outbreak.

About 5 million Tamiflu prescriptions were dispensed in Japan last flu season, down from a high of 9 million two years earlier. There were about 2 million prescriptions in the U.S. last year, according to Roche's data. Children account for half of sales.

Only about 2,000 Relenza prescriptions were dispensed in the U.S. last flu season, according to the FDA. London-based Glaxo said the drug's sales fell 7 percent to 28 million pounds ($58 million) in the third quarter.

To contact the reporter on this story: Catherine Larkin in Gaithersburg, Maryland, at [email protected]

Last Updated: November 27, 2007 18:57 EST