The 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 new caution for stimulants such as Ritalin, which came to light last week, follows a wave of recent concerns over antidepressants and painkillers.
Meanwhile, some analysts and doctors say the warnings are unlikely to affect the millions of ADHD prescriptions written each month.
Senate Finance Committee Chairman Charles Grassley questioned why the FDA and drugmakers did not announce the changes.
"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, said Thursday.
"It's of great concern if the FDA took a keep-it-quiet approach in order to protect the drug companies," he said.
Months after two FDA advisory panels offered conflicting opinions over the warnings, the FDA in May asked most ADHD drugmakers to add warnings.
Its decision was made public Monday when the FDA released a letter GlaxoSmithKline, maker of Dexedrine, sent to doctors. Others include Adderall, Focalin and Concerta.
"I do wish it had been done in a more public way," agreed Dr. Steven Nissen, who was a member of the FDA panel who pushed for strong boxed warnings on the drugs when it met in February.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
# posted by Network @ 9:01 AM
