FDA Fails To Send Alerts On 20% Of Class 1 Drug Recalls

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FDA Fails To Send Alerts On 20% Of Class 1 Drug Recalls

Study over 8 years finds 18 recalls never publicized

June 5, 2012 | By Eric Palmer

The FDA hasn't always been on top of notifications to medical providers about the most serious drug recalls, a study has found. Between 2004 and 2011, nearly 20% of the Class I drugs recalls were not included in either of the agency's two alert systems, reports Reuters. Class I drugs include those that can cause "serious adverse health consequences or death." Over the 8 years, Joshua Gagne of Brigham and Women's Hospital in Boston and other researchers counted more than 1,700 FDA drug recalls and found only 91 were serious Class I recalls. The agency sent out 2,900 announcements through the Recall Alert System but included alerts for just 55 of the 91 Class I recalls. Its MedWatch system picked up another 18 of the remaining recalls, but 18 more, or 20% of the Class I recalls, were not reported through either system, the study found. The researchers acknowledge they couldn't document any adverse effects related to the failure and also that FDA has made strides in the last year. They suggest, however, that the agency set up a system specific to Class I drugs. The problem of recalls is complex. A recent report found that last year there were 55 prescription drug recalls and 14 recalls related to OTC products, but the OTC recalls involved millions more products. Story | More

Thank You Fierce Pharma Manufacturing and Mr Palmer


see also PubMed:


Under Reporting Of Adverse Drug Reactions A Systematic Review

"The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%)."

Top, People, ......, Dr Jones, ........ Top, People, the best that money can buy, are working on the it. 


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