Health — 04 November 2013

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.


About Author

Pat Anson, Editor

Pat is Editor in Chief of American News Report. He is a veteran journalist and a former correspondent and producer for HealthWeek (PBS), Nightly Business Report (PBS) and other nationally syndicated shows. Pat has won numerous journalism awards, including a Golden Mike award for investigative reporting.

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