US FDA's quiet move on ADHD drugs draws complaints

scotty · 08-24-2006, 08:44 PM

US FDA's quiet move on ADHD drugs draws complaints
Thu Aug 24, 2006 5:22pm ET

WASHINGTON, Aug 24 (Reuters) - The U.S. Food and Drug Administration's quiet decision to require heart and psychiatric warnings on attention deficit drugs has sparked new criticism from a top Republican senator and others over the agency's handling of safety issues.

The agency's new caution for stimulants like Novartis AG's (NOVN.VX: Quote, Profile, Research) (NVS.N: Quote, Profile, Research) Ritalin, which came to light this week, follows a wave of recent concerns over safety problems linked with antidepressants and painkillers.

Meanwhile, some analysts and doctors say the warnings, over possible heart risks and psychiatric problems, are unlikely to affect the millions of ADHD prescriptions written each month.

Senate Finance Committee Chairman Charles Grassley said the FDA should have been more forthcoming and questioned why the agency and drugmakers did not announce the changes for attention deficit hyperactivity disorder, or ADHD, drugs.

"Doctors, parents and patients deserved to hear about the changes. They shouldn't have to search high and low for information," Grassley, an Iowa Republican, told Reuters on Thursday.

"It's of great concern if the FDA took a keep-it-quiet approach in order to protect the drug companies," he added.

Months after two FDA advisory panels offered conflicting opinions over the warnings, the FDA in May asked most ADHD drug manufacturers to add the warnings.

Its decision was made public Monday when the FDA released a letter GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research)(GSK.N: Quote, Profile, Research) sent to doctors. Continued at link:

http://today.reuters.com/news/articl...EALTH-ADHD.XML

LCrawford67 · 08-24-2006, 08:53 PM

Ok, let me say that I'm shocked it's a republican speaking out about this! No offense, but let's face it....this administration, the FDA, and Big Pharma are all in bed together.

scotty · 08-24-2006, 09:17 PM

Grassley is one of our greatest supporters!!!!

Amaya's Nana · 08-24-2006, 09:22 PM

I think the FDA needs to be disbanded and reorganized. Somethin's rotten in Denmark and it stinks to high heaven!!!!

Lilly · 08-24-2006, 09:22 PM

I was surprised too!

Lilly

rdjanis · 08-24-2006, 09:25 PM

Quote:

Senate Finance Committee Chairman Charles Grassley said the FDA should have been more forthcoming and questioned why the agency and drugmakers did not announce the changes for attention deficit hyperactivity disorder, or ADHD, drugs.

"Doctors, parents and patients deserved to hear about the changes. They shouldn't have to search high and low for information," Grassley, an Iowa Republican, told Reuters on Thursday.

Right on!! Good for Grassley!!

scotty · 08-24-2006, 09:25 PM

Quote:

Originally Posted by Junebug's Baby

I think the FDA needs to be disbanded and reorganized. Somethin's rotten in Denmark and it stinks to high heaven!!!!

That is exactly what needs to happen!

08-24-2006, 08:44 PM	#1
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 47,007	US FDA's quiet move on ADHD drugs draws complaints US FDA's quiet move on ADHD drugs draws complaints Thu Aug 24, 2006 5:22pm ET WASHINGTON, Aug 24 (Reuters) - The U.S. Food and Drug Administration's quiet decision to require heart and psychiatric warnings on attention deficit drugs has sparked new criticism from a top Republican senator and others over the agency's handling of safety issues. The agency's new caution for stimulants like Novartis AG's (NOVN.VX: Quote, Profile, Research) (NVS.N: Quote, Profile, Research) Ritalin, which came to light this week, follows a wave of recent concerns over safety problems linked with antidepressants and painkillers. Meanwhile, some analysts and doctors say the warnings, over possible heart risks and psychiatric problems, are unlikely to affect the millions of ADHD prescriptions written each month. Senate Finance Committee Chairman Charles Grassley said the FDA should have been more forthcoming and questioned why the agency and drugmakers did not announce the changes for attention deficit hyperactivity disorder, or ADHD, drugs. "Doctors, parents and patients deserved to hear about the changes. They shouldn't have to search high and low for information," Grassley, an Iowa Republican, told Reuters on Thursday. "It's of great concern if the FDA took a keep-it-quiet approach in order to protect the drug companies," he added. Months after two FDA advisory panels offered conflicting opinions over the warnings, the FDA in May asked most ADHD drug manufacturers to add the warnings. Its decision was made public Monday when the FDA released a letter GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research)(GSK.N: Quote, Profile, Research) sent to doctors. Continued at link: http://today.reuters.com/news/articl...EALTH-ADHD.XML __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

08-24-2006, 08:53 PM	#2
LCrawford67 Moderator "Everybody poops" Join Date: Mar 2006 Location: Ohio Posts: 34,484	Re: US FDA's quiet move on ADHD drugs draws complaints Ok, let me say that I'm shocked it's a republican speaking out about this! No offense, but let's face it....this administration, the FDA, and Big Pharma are all in bed together. __________________ aka LC aka Laurie C. Paxil, 20 mg since 1997, for IBS Two unsuccessful attempts to quit. Started tapering 11/27/06 PAXIL FREE 12/29/07 Today is the best day, EVER!

08-24-2006, 09:17 PM	#3
scotty Administrator Join Date: Feb 2004 Location: new jersey Posts: 47,007	Re: US FDA's quiet move on ADHD drugs draws complaints Grassley is one of our greatest supporters!!!! __________________ AKA Laurie "Faith is taking the first step even when you don't see the whole staircase." MLK

08-24-2006, 09:22 PM	#4
Amaya's Nana An "A bucket" gal! Join Date: Nov 2005 Location: Houston, Texas Posts: 6,467	Re: US FDA's quiet move on ADHD drugs draws complaints I think the FDA needs to be disbanded and reorganized. Somethin's rotten in Denmark and it stinks to high heaven!!!! __________________ a/k/a Lisa PAXIL FREE AS OF 3/18/06! Fully recovered! Focus your attention on the here and now. Recognize it for what it is: the one moment of the only life you will ever have that you truly possess. Rare is the individual who has come to completely accept that the past is no more than a memory and the future an assumption about unborn events.

08-24-2006, 09:22 PM	#5
Lilly Join Date: Jun 2002 Location: Northwest Posts: 7,188	Re: US FDA's quiet move on ADHD drugs draws complaints I was surprised too! Lilly __________________ 1 .5 Xanax a day for one month. C/T. Same year, 3 .5 mil Xanax a day, 4 by the end. Pooped out on me. 1 1/2 years on the drug. Doctors taper. Very bad w/d. 9 months later took 10 mg Paxil and my Xanax w/d dissapeared. On 20 mg by end. Pooped out on me. C/T then restarted it again after 3 days and big blow up. 6 months taper, never feeling much better. 2 1/2 years solid w/d then sporadic stuff for 5 years. Completely recovered! Drug free since June 2001.

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