Boomer consumer alert: List of 20 potential problem prescription drugs now available from FDA

The U.S. Food and Drug Administration is offering listings of prescription drugs under investigation for potential safety problems. This information is helpful to the Baby Boomer Generation because nearly one-third of baby boomers take four or more prescription drugs for chronic conditions, according to a 2003 prescription drug survey by Knowledge Systems & Research Inc.
 
The FDA is releasing the information to keep health care providers and patients informed about possible problems earlier. Its first list was issue on Friday.
 
Twenty medications are included in the FDA’s chart, with a potential issue for each. No indication is provided of how widespread or serious the problems may be, according to an Associated Press article “FDA Posts List of Potential Problem Drugs.”

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
January – March 2008

Some consumer advocates question usefulness of the brief information, and the drug industry worries that patients may stop taking a medication if they see it listed, according to the article.

At least five of the drugs on the list had problems that already have been publicized, the article states. These included the blood thinner heparin, recalled earlier this year, and immune-suppressing medications being studied for a link to cancer in children and young adults.
 
Each quarter, a new report will be posted on FDA's Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified based on reports the FDA receives from hospitals, doctors, and patients.
 
The appearance of a drug on this list doesn’t mean that the 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, the FDA said in a statement about the new listing. It’s 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.
 
Congress directed the FDA to develop the quarterly report of potential safety issues under the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. Patients and health care professionals told Congress that they want to be informed about possible safety problems with prescription drugs sooner.