By Pat Anson, Editor
The expedited review and approval of new drugs by the Food and Drug Administration may have exposed some patients to substantial safety risks, according to a study published in JAMA Internal Medicine.
The study analyzed 20 new drugs that were approved by the FDA in 2008 – including Johnson & Johnson’s opioid pain medicine Nucynta (tapentadol). Eight drugs were given expedited review and 12 had a standard review.
The researchers found that expedited drugs underwent an average of just over 5 years of clinical testing before being approved, compared to 7.5 years for those that had a standard review.
Perhaps more importantly, the number of people tested during clinical trials was substantially different: during expedited reviews a median of 626 patients were exposed to a drug, compared to 2,133 in a standard review.
“The study shows that new drugs – especially novel drugs – are developed and approved quickly, but that testing is modest and many safety questions are left unanswered for years,” study co-author Thomas Moore of the Institute for Safe Medication Practices told Pharmalot.
Read more at National Pain Report.
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November 12, 2012
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Oh boy...Your right we hate to hear this. You know why people in pain
Doesn't the 1.5 billion is spent a year give credence to its possitive
Many MS drugs cause PML and deaths too these drugs all need t
I knew him when he was breaking in at a couple of Los Angeles TV stati
Saying there is a 'twist' is the worst type of spoile