Does FDA Go Overboard With Epilepsy Warnings?
11 CommentsBy Ed Silverman // July 10th, 2008 // 11:28 am
As the agency holds an advisory committee meeting today to review a proposal to slap Black Box warnings on epilepsy meds due to concerns about suicidal behavior and thoughts, some docs say the FDA may be overreacting and question whether the move will do patients any good.
As we noted, a recent FDA analysis of nearly 200 studies found patients on epilepsy meds were more likely to have suicidal thoughts and behaviors than those on placebo - on average, 0.43 percent compared with 0.22 percent. Agency officials, however, acknowledge the effect was rare and remain uncertain about the cause. Look here for the back story and FDA documents.
“Suicide is always a risk in patients with epilepsy, whether taking medication or not,” Philip Walson, an adjunct professor of pediatrics at Cincinnati Children’s Hospital, tells ABC News. “Time will tell whether the association is real or not…I think the information belongs in the labeling but not as a black box.
“Overuse of the black box will dilute its effects. Iit should be reserved for more clear-cut and higher-risk problems. The FDA, in my opinion, is making an honest attempt to react appropriately to new information as it comes available. Unfortunately, the FDA has limited ability to influence medical practice.”
“You have to wonder what the doctor or patient is supposed to do with the information that a drug causes an increased risk of suicide,” Cliff Saper, a professor of neurology and neuroscience at Harvard Medical School, tells the TV network. “There is no evidence - that I know of - that providing this information to the patient, who needs to take the drug anyway, will reduce that risk.”
Mark Stacy, a Duke University neurologist, wonders whether the studies show a slight increase of suicide, or did many find nothing and only a few show a drastic increase? If so, for what drug and which type of patient? “The devil is in these details,” he tells ABC. “I believe it would also be important to review these data by drug; this would allow assessment of individual compounds, rather than by class.”
Lisa Van S
Ed,
I noticed their was no financial disclosure for Dr. Walson, his statement sounds like industry wrote it for him.
AAP & APA speak the same language, when you cant blame the drug,..blame the child. YADDA YADDA YADDA
Justice in MI
As I wrote in another thread, I do worry about the black box being over-used, and thus the little impact it already has will be further diluted.
Also tend to agree with Dr. Stacy. It seems unlikely to me that all of these meds have the same degree of risk as a class. I’m assuming, as with NSAIDS, we don’t have the data to know. But, for epilepsy pts, it is essentially a wash since they have to use something.
So here is a “big reaction” which seems guaranteed to have no impact - and some likelihood (via dilution of black box) of having the wrong impact.
Justice in MI
Per Lisa’s comment, if you are concerned that the fight against the black box is a potential “cover-up,” I think the opposite is true. By boxing all, the drugs that may be of true concern are camoflaged. And, as in post above, this leaves pts potentially _more_ vulnerable who happen to be using those.
Perhaps ironically, then, this may be a case of over-regulation that works against more useful regulation.
Atlex
JiM,
A minor correction to your comment. This is not like NSAIDS–all of those drugs have the same general mechanism of action. These drugs are in multiple classes with very different MOAs. In addition, almost all of these drugs have other uses, and while the black box looks as though it will only be associated with epilepsy, there is certainly not “a wash” in other conditions.
Atlex
Justice in MI
Thanks, Atlex. Excellent points.
Mary
I wonder what the Medwatch numbers show for who becomes suicidal on Lamictal. In our case, using it (with great encouragement from the doctor, who is on a Glaxo Lamictal “Board”) for bipolar depression was a flaming disaster. Perhaps the same is not true of those using it for epilepsy.
I’d still rather have the black box. However, the most ignored black box of all is off label use of antipsychotics for our elders with dementia. No one is paying attention. On the other hand, there are a number of other maneuvers the FDA could take that are not black box. Do they take them, in the name of safety? Of course not.
Justice in MI
Agree with you, Mary. It’s been shown again and again that all the “titrating” of warnings, etc., means virtually nothing in terms of rx’ing practice.
What _may_ make a difference are serious studies that demonstrate whatever relevant risks, published in the relevant places and “detailed” by more than a box on an insert that nobody reads (of the Dr. HCP that also mostly go unread).
It’s Alice-in-Wonderland drug safety.
pg
If pharma behaved itself and engaged for a change in ’scientific’ research (ie, no scientific fraud), in open scientific debate and general transparency, none of us would need to question their motives. What we do know is that their fraudulent behaviour leads to injury to others. What we also know is that every day some people will be suffering as a result of fraudulent science while we debate the ifs and whys and what and who we think it applies to.
Isn’t there something we could all do together in a call for ethical scientific research and honest regulation? If we all, everyone who basically wants honest science, worked together then couldn’t we make a difference regardless of differences in the whos, ifs, whys, whats and hows?
Isn’t HONEST science all most of us want? Isn’t there a way we can all just go for that aim?
pg
PS, I get a feeling that we all waste a lot of energy in some way by debating the rights and wrongs of individual drugs, or case, or prescriptions.
So we need to do that?
Would it be more productive to all get together and go for ethical research in all drugs?
If everyone joined together to simply go for ethical research, would that result in better medicine?
I don’t know. Just wondering what we’re all doing wrong to effect absolutely no change.
pg
Sorry, not “So we need to do that?” (typo) “DO we need to do that?” is what it was meant to be.
Just A Thought
The thing with this one was that it could have hurt both the industry and the consumer. I’m no great fan of the industry right now, but I’m not about to shoot myself in the foot. The industry can shoot their own feet if they choose.