From
The Houston Chronicle:
The government on Friday began posting a list of
prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients.
The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed.
Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.
"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research. "If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."
The first list included some drugs whose problems already have been publicized, such as the blood thinner heparin and immune-suppressing medications that are being studied for a possible link to cancer in youngsters. Several medications administered in hospitals were listed because of overdoses linked to possibly confusing instructions. Among the drugs taken in the home, insulin and nitroglycerin were cited because of possibly confusing instructions that might be contributing to patients getting the wrong doses.
The listings will be updated for each calendar quarter.
Drugs will be placed on the list based on reports the FDA receives regularly from hospitals, doctors and patients. The list is not just a reflection of raw data, but more like what a police officer would call "probable cause." Officials said a drug will only be listed if FDA safety reviewers determine that a reported problem deserves a closer look.
Consumer advocates called the listing a positive step, but said it needs to be fleshed out.