No Black Box Warnings For Epilepsy Drugs: Panel
10 CommentsBy Ed Silverman // July 10th, 2008 // 4:19 pm
Two agency advisory committees voted unanimously today that 11 different epilepsy medications can cause increased risks of suicide, but voted 14-4 against adding a Black Box about those risks on the drug labeling, a boon to several drugmakers, notably Pfizer, which sells Lyrica.
The panel’s vote about the Black Box warnings broke down along professional lines, with psychiatrists and neurologists voting against, and statisticians favoring the warnings. 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. The agency, however, noted the effect was rare and remain uncertain about the cause.
Interestingly, the panel decision not to recommend Black Box warnings comes as some docs were questioning whether the FDA may have been overreacting and if such a move would do patients any good. The meds, by the way, generated more than $10 billion in sales last year and are taken by an estimated 10 million Americans.
Source: Associated Press
Just A Thought
I should be insulted that they are doing this based mostly on other uses for these treatments. Forget the epileptics who have been taking them for years. They’re depressed anyway. Pfffffffft!
I’d far prefer the FDA go review some ANDAs or something.
Atlex
Just a Thought,
The interesting part is that the reports suggest that FDA was only going to add the black box for the epilepsy indication and not for other indications.
Atlex
Justice in MI
Interesting. Atlex or others - how do you add a black box just for epilepsy? I assume the text inside the box says so. But it would be my impresssion, at least, that what rx’ers see (if they notice at all) are the outlines of the box, not what’s inside.
All of which leaves me feeling that much more that, in lieu of more specific studies on specific meds (yes, in the context of specific conditions), we’re playing box ball.
Atlex
JiM,
If rumors are to be believed, the black box would have specified that the increase in suicides, though still rare, only occurred when the drugs were used in the treatment of epilepsy. While the prescriber may focus on the black box and not what’s inside, the pharma reps would have been very specific that the AE only occurred in epilepsy.
I infer from your comment that you’d agree that the FDA needs to come up with a better system of communicating such warnings. The more drugs and drug categories that receive black boxes, the less valuable such warnings become.
Atlex
Just A Thought
I have to say, the FDA has done something I approve of. Not for the benefit of the industry but for the credibility of the consumers.
We don’t need anyone telling us we’re depressed to the extent of possible suicide. Next thing you know they’d start locking us up in sanitariums. Or placing us on drugs against our will. Been there (well not me- but you know).
Justice in MI
“I infer from your comment that you’d agree that the FDA needs to come up with a better system of communicating such warnings. The more drugs and drug categories that receive black boxes, the less valuable such warnings become.”
Yes, I do agree. Some of those here with much more experience than I have will be able to say whether or not the black box used to mean much more than it does. Certainly my sense is that might be true when a particular drug was singled out, rather than a class, even for a specific indication.
This will probably _not_ provoke agreement. But in Canada’s very different system, I understand that there were particular criteria that had to be met before Vioxx could be rx’d at all. No known CV risk, history of GI problems, lack of efficacy with other NSAIDS, etc.
I understand that these guidelines were not always followed. But they fit better with what was coming to be known than once size fits all. _Had_ they been followed, Vioxx would almost certainly still be available to those who were the right pts for it. Yet folks who wish it was still available almost always blame the “pharma critics” rather than the blockbuster model.
That said, I also understand that such titrating has generally failed - both practically and politically - in the U.S..
learning
Just wondering how many prescriptions are written off-label (other than epilepsy) for this type of drugs? I bet they are many more being prescribed off-label than for the people for whom these drugs are/were initially intended.
Mary
Well, the Medguide system is broken (no medguides for Zyprexa or the other atypicals, despite testimony a year ago at an FDA hearing), and these black boxes were being considered only for epilepsy. Wrong! My daughter’s suicidal impulses were strong on Lamictal for bipolar depression (somehow Glaxo got this approval) and she had to be hospitalized to taper off. It was very real, and it will be interesting to see if this risk will be acknowledged on the tiny print that will ensue eventially on this class of drugs.
gary
Just a little confused over the ACs conclusions based on the statistics. The 11 drugs do have increased Suicidal Behavior or Ideation, whereas trials in non-US areas only “may have”..??
With an OR of 1.80 (95% CI: 1.24, 2.66), suicidal Behavior or Ideation “were associated with statistically significant increased risk of Suicidal Behavior or Ideation events relative to placebo.”
With an OR of 4.53 (1.86, 13.18) “Non-North American patients may have higher relative risks.”
WEL
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