Home / Health / News Tools: Save | Print | E-mail | Most Read | Comment
FDA posts list of drugs with potential safety issues
Adjust font size:

The U.S. Food and Drug Administration announced Friday that it has posted on its website its first quarterly report that lists certain drugs that are being evaluated for potential safety issues.

The appearance of a drug on this list does not mean that the FDA has concluded that the drug has the listed risk, or that the 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," said FDA in a statement.

"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, director of FDA's Center for Drug Evaluation and Research.

The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS), which contains millions of reports of adverse events submitted to the FDA by drug manufacturers, health care professionals and patients.

Under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007, the FDA was required to inform the public each quarter of new safety information or potential signals of serious risk.

For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

This first quarterly report lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA's website listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS.

(Xinhua News Agency September 8, 2008)

 

Tools: Save | Print | E-mail | Most Read
Comment
Pet Name
Anonymous
China Archives
Related >>
- FDA warns of risk linked to diabetes drug Byetta
- FDA approves new stent for sale in US market
- FDA OKs first rapid blood test for MRSA infection
- FDA to investigate U.S.-made leaded lipsticks
- FDA requires strongest warnings on antiboitics for tendon risks
- FDA: Avoid Toothpaste Made in China
- Shanghai FDA Warns About Caustic Soda Shrimps
- TCM to Take FDA's Test of Curative Effect
Most Viewed >>
- Beijing students to get free health checkup
- Asian mania for skin whitening
- US scientists uncover how Ebola virus invades cell
- What's wrong with ice cream in summer time?
- China moves to assess village doctors' qualification