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The FDA's Adverse Event Reporter: Inadequate

WASHINGTON September 5, 2008 (AP)

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.

The webpage on the FDA website is indeed a rather bare bones affair. And it doesn’t go nearly far enough in describing how widespread some of these “issues” are. For instance, if the “potential for risk” for a drug called Suprane is, apparently, “cardiac arrest,” then perhaps the public would be better served if they were told exactly how many people had heart attacks, if any, and what sort of condition they were in when they started taking the medication.

The site could also stand to be a little clearer on some of the problems. Considering that the vast majority of the population did not go to medical school, it is doubtful that many of us would have the slightest idea as to what “Purple Glove Syndrome” is.

It also seems to be a little dated. For instance, the notoriously addictive and poorly prescribed painkiller OxyContin is listed here as having the risk of “Drug misuse, abuse and overdose,” which was big news back in 2003. When OxyContin first came out it was marketed almost exclusively to doctors with no background in pain management as a “non-addictive” pain killer, which is the exact opposite of what it actually was. So while it’s good that the FDA has finally caught up here, we have to wonder what took them so long. If we are using OxyContin as a yardstick as to how quickly this process works, then we have a feeling that this list that comes out every three months might not be a very helpful addition.

There is also a disclaimer that makes us nervous.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Again, if Oxy Contin is just making the list, then there seems to be a problem here. This makes us wonder exactly how long people have been suffering from “cardiac arrest” from the drug Suprane, and it makes us wonder exactly how long people have been suffering from anaphylactic shock when they take Heparin.

There are also examples of the FDA dragging its feet when there are things on the list that could be taken care of tomorrow. For instance, of the twenty drugs on the list, five of them (that’s 25% to me and you) are on the list due to “packaging problems,” or “labeling problems,” or “naming problems.” It is beyond us as to why the FDA doesn’t simply order new packaging, new labeling or new names rather than start a “further evaluation” process. One overdose due to drugs with identical labels is more than enough.

There are, of course, several answers as to why this sort of thing always seems to take so long. Drug development and drug approval takes an extraordinarily long time, and for good reason. And there could be mitigating circumstances as to how or why some people suffer injuries when taking a medication. But Vioxx reminded us all as of the consequences of an FDA that is susceptible to lobbying, and if people are suffering adverse reactions due to the use of these drugs, surely there must be a way to speed up investigations and to come up with solutions to the problems.

At Breit, Drescher and Imprevento, we have offered legal help for those who have suffered due to drugs that were pushed through to the market with all the regard in the world for profit margins and very little regard for safety. Because there can be a very fine line between a cure and a cause of death, we take the behavior of the drug companies very seriously.

If you or a loved one has been injured due to a drug that was not prescribed correctly, or been injured due to a prescription that turned out to be dangerous, contact Breit, Drescher and Imprevento today.

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