http://today.reuters.com/news/articleinvesting.aspx?type=governmentFilingsNews&storyID=2006-08-24T212230Z_01_N24469737_RTRIDST_0_HEALTH-ADHD.XML

US FDA's quiet move on ADHD drugs draws complaints

Thu Aug 24, 2006 5:22pm ET

By Susan Heavey

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...