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FDA Posts Quarterly List Of Questionable Drugs

Posted by Jane Akre
Friday, September 05, 2008 6:21 PM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Cymbalta, Drug Products, Adverse Events, Defective Drugs

Cymbalta is on an FDA adverse health events list for the first quarter of 2008.

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IMAGE SOURCE:  Wikimedia Commons/ Cymbalta/ author: Military ace 

 

For the first time, the Food and Drug Administration (FDA) is publishing a list of drugs on the market that are under review for safety issues.  Expect the list to be updated quarterly so consumers can check in regularly to see which of their prescriptions may be under the microscope. 

Part of the new FDA Amendments Act, which was signed into law a year ago, it requires the agency to make public the potential signs of serious risk based on adverse health event reports coming into the FDA.

But consumers need to know that being named does not necessarily mean a drug is dangerous or that doctors should not prescribe it.

Dr. Janet Woodcock, direct of the FDA's Center for Drug Evaluation and Research tells the Los Angeles Times:

"My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."

So far in the first quarter of 2008,  20 drugs are on the list, including antidepressant, Cymbalta.

It has reports of urinary retention.  Also on the list, Tysabri for reports of melanoma skin cancer.  Revlimid, for multiple myeloma has been linked to a skin condition that is potentially life-threatening.

The lists will not be cumulative each quarter but will reflect the drugs the FDA is currently focusing on.  

The reports are the result of complaints by the public and physicians that the FDA is not being forthcoming about potential safety problems.  #


1 Comment

Posted by Austin Lee
Saturday, September 06, 2008 12:05 PM EST

This FDA effort is a good thing. It creates a bit more transparency and provides a glimpse into undesirable drug effects, and issues that manufacturers can address.
Austin
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