Prescription drug law that retailers should be aware of. The U.S. Food and Drug Administration Amendments Act .

September 8th, 2008

In an effort to aid retailers in keeping abreast of product safety inforamtion beyond just providing rss feeds

In an effort to aid retailers in keeping abreast of product safety inforamtion beyond just providing rss feeds, the following is information taken from a U.S. FDA post to their website http://www.fda.gov/bbs/topics/NEWS/2008/NEW01881.html on September 5th. This information is important for all companies that distribute prescription drugs when counseling their customers regarding their continued use, or customers seeking inforamtion for new prescriptions.

The U.S. Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007 requires that the FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency’s review of adverse event reports contained in AERS.

The U.S. Food and Drug Administration announced on September 5th that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA’s Adverse Event Reporting System (AERS).

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.

“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,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.

Please visit http://www.fda.gov/ to review in more detail the list of medications included in this report.

We look forward to your comments.

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