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Editor: Katharine Van Tassel
Creighton University School of Law

Friday, September 5, 2008

FDA Posts List of Potential Problem Drugs

The Washington Post reports that 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.  Ricardo Alonso-Zaldivar writes,

Pills9The 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 have already 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 may be contributing to patients getting the wrong doses.

The listings will be updated for each calendar quarter.

"What's new here is that we are telling the public really at the earliest stage what we are working on," said Dr. Gerald Dal Pan, head of the Food and Drug Administration's drug safety office. "I think the public told us, 'We want to know what you are working on.' And we are responding to that."

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.

"Our hope is that this list will serve not only as a means of communication to the public, but that it will also serve to encourage (medical) providers to provide us with additional reports should they see similar kinds of adverse events with the drugs that are on the list," said Dr. Paul Seligman, who is responsible for the FDA's safety communications.

Consumer advocates called the listing a positive step, but said it needs to be fleshed out.

"It's a good thing to get started but it needs to have much more detail if it's to have significant safety value," said Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices. "A table with just a few words of description is quite limited."

"It's just the most basic warning system," said Diana Zuckerman, president of the National Research Center for Women and Families. "It's not going to say how many reports there were. It's not going to say how many died and how many were hospitalized."

Nor is it clear how drugs suspected of a problem will be removed from the list if later exonerated.

The FDA's Seligman suggested that may change. "I will be the first to admit there is some work and refinement that needs to be done on this table," he said.

The Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, said it supports giving more safety information to doctors and patients, but worries that some will be needlessly alarmed.

"Our reservation is that patients will be abruptly stopping therapy," said Alan Goldhammer, a vice president of the organization. "One can't generalize with an emerging safety notice. It may affect half the patients, a quarter of the patients, or only a small subset of the patients."

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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.

Posted by: Austin Lee | Sep 6, 2008 8:32:46 AM

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