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September 22, 2006

Panel Reports on State of Drug Safety

A panel convened by The Institute of Medicine has released a report called "The Future of Drug Safety." The report addresses drug safety in the U.S. and issues within the FDA.

The panel found that the FDA is lacking the funding and manpower to do its job properly. They also found that new drugs are given too much leeway before their safety has been properly established and that drugs should continue to be reviewed for safety five years after they are put on the market.

"More drugs are being approved faster with less time to intensively investigate premarketing safety data," the report said. And FDA does not have the resources to keep up once the drugs reach the market in assessing safety or informing the public about any risks that might develop.

New steps needed to ensure drug safety, panel says
FDA Told U.S. Drug System Is Broken
Institute of Medicine

Posted by Staff at 10:33 AM | Comments (0)

August 25, 2006

FDA Orders Label Changes for Dexedrine

The FDA has asked pharmaceutical company GlaxoSmithKline to add a warning to ADHD drug Dexedrine alerting patients to possible risk of heart problems when taking the drug.

The warning describes some instances of sudden death in children and teens with structural cardiac abnormalities or other heart problems. It also mentions various potential psychological side effects, including hallucinations or delusional thinking.

ADHD Drug to Get Stronger Warning

Cardiovascular Safety Warning Added for Stimulants for ADHD

Posted by Staff at 1:25 AM | Comments (0)

August 19, 2006

The FDA and MIT Work on Drug Safety

The FDA is collaborating with MIT to come up with better ways to ensure drug safety. Given the FDA's poor track record in recent years in monitoring drug safety this is definitely a step in the right direction, but is it enough?

The Food and Drug Administration and Massachusetts Institute of Technology announced Thursday an agreement to develop an automated system to detect unanticipated problems with prescription drugs and medical devices.

FDA, MIT to Collaborate on Drug Safety
US FDA, MIT to work on tracking drug side effects

Posted by Staff at 4:02 AM | Comments (0)


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