* Newstin.co.uk is for sale! * After achieving our strategic milestone, we are offering for sale: Newstin.co.uk and all 14 related domains featuring 1 million unique visitors per month + continuously updated news database of 37 million articles in 12 world languages from 166,000 global and weighted sources + 2.1 billion metadata * To seize this unique chance, contact invest@newstin.com. * Newstin.co.uk is for sale! *
Full Coverage

FDA seeks black box warning for epilepsy drugs

pharmiweb.co.uk
07-Jul-2008
        
Story Timeline:  97 days

WASHINGTON (Reuters) - U.S. Food and Drug Administration officials will seek a strong "black box" warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters on Monday. "We are going to ask for a boxed warning on these drugs," said FDA spokeswoman Sandy Walsh. The news comes ahead of an FDA advisory panel meeting on Thursday to discuss the drugs' risks. The FDA plans to seek comment from its outside advisers on the proposed warning, Walsh said. GlaxoSmithKline Plc's Lamictal and Pfizer Inc's Lyrica are among the top-selling epilepsy drugs. Others include Johnson & Johnson's Topamax and Abbott Laboratories Inc's Depakote. (Reporting by Susan Heavey; editing by John Wallace) Next Article: FACTBOX-Details of Fed, SEC investment bank... [read full story]                    

Add Comment
Latest article on this story:

U.S. panel rejects strong epilepsy drug warning

 reutershealth.com 11-Jul-2008
First article on this story:

FDA seeks black box warning for epilepsy drugs

 reuters.com 07-Jul-2008
Selected publications with coverage of this story:
orglex.com zdnet.com reverbiage.com wcbstv.com moldova.org wired.com tbo.com kcby.com kwch.com go.com iht.com cbs4denver.com
RELATED
Found 58 documents:
                   

Pfizer Looking at a Level Playing Field

pharmiweb.co.uk
11-Jul-2008
        

By Brian Orelli July 11, 2008 Comments (0) It was a good play. When Pfizer's (NYSE: PFE) epilepsy drug Lyrica was included in a list of 11 drugs that might need a black-box warning, company executives said it wasn't so. They...

U.S. Panel Rejects Strong Epilepsy Drug Warning

pharmiweb.co.uk
11-Jul-2008
        

Reuters Health - Jul. 11, 2008 By Susan Heavey BELTSVILLE, Md. (Reuters) - Anti-seizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a...

                   

FDA Told to Skip â€Black Box’ on Epilepsy Drugs and Suicide

pharmiweb.co.uk
11-Jul-2008
        

Until yesterday, the FDA had been rolling steadily toward slapping a black-box warning on epilepsy drugs because they may increase the risk of suicidal thoughts and behaviors. But a committee of outside experts convened by the...

                   

FDA Panel Votes Against Tough Warnings For Epilepsy Drugs

pharmiweb.co.uk
11-Jul-2008
        

By Jared A. Favole Of DOW JONES NEWSWIRES BELTSVILLE, Md. -(Dow Jones)- The FDA had previously said it wants to add the black-box warnings to more than 10 epilepsy drugs after studies showed their use led to a risk of suicidal...

FDA Panel Rejects Black Box Warnings For Epilepsy Drugs

pharmiweb.co.uk
11-Jul-2008
        

Nidhi Sharma - AHN News Writer Beltsville, MD (AHN) - Members of the Food and Drug Administration's panel of outside experts on Thursday did not recommend adding the agency's toughest warnings to labels of epilepsy drugs,...

                   

FDA panel sees suicide risks with epilepsy drugs; analyzed 200 studies

pharmiweb.co.uk
11-Jul-2008
        

By Matthew Perrone, The Associated Press WASHINGTON - Drugs used by millions of Americans to treat epileptic seizures can cause increased risks of suicide, a government panel said Thursday. Advisers to the U.S. Food and Drug...

FDA Panel Votes Against Black Box on Epilepsy Drugs

pharmiweb.co.uk
11-Jul-2008
        

BioWorld Today - Jul. 11, 2008 BELTSVILLE, Md. - Even though a federal panel said they agreed with the FDA's findings that there is an increased risk of suicidal thoughts and behaviors - suicidality - with antiepileptic drugs,...

                   

FDA panel: no black box warning on epilepsy drugs [XFNA]

pharmiweb.co.uk
11-Jul-2008
        

WASHINGTON (AP) - The panel vote against that plan makes it less likely that blockbuster drugs from GlaxoSmithKline, Pfizer Inc., Merck & Co. Inc. and others will carry the FDA's sternest warning. In a separate vote, panelists...

FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs

pharmiweb.co.uk
11-Jul-2008
        

Experts do find 11 anti-seizure drugs heighten suicide risk, and they recommend medication guide for doctors By Steve Reinberg HealthDay Reporter THURSDAY, July 10 (HealthDay News) -- Anti-seizure drugs can cause increased...

                   

UPDATE: FDA Panel Rejects Tough Warnings For Epilepsy Drugs

pharmiweb.co.uk
10-Jul-2008
        

By Jared A. Favole Of DOW JONES NEWSWIRES BELTSVILLE, Md. -(Dow Jones)- The FDA had previously said it wants to add the black-box warnings to more than 10 epilepsy drugs after studies showed their use led to a risk of suicidal...

1 2 3 4 5 next »