FDA To Post List Of Drugs With Safety Issues
8 CommentsBy Ed Silverman // September 5th, 2008 // 11:37 am
In keeping with its new mandate to pay closer attention to safety, the agency will be compiling a quarterly table of drugs that have been identified as having some kind of potential safety issue. The move is actually in response to a requirement in the FDA Amendments Act and the first table, to be posted on the agency web site, includes 20 different drugs identified in this year’s first quarter.
The list includes Cymbalta, Tykerb, Heparin, Revlimid, Tysabri, OxyContin, Dilantin and Seroquel. Take a look for yourself.
“We’ll be informing the public of certain drugs that are being evaluated for potential safety issues based on certain issues that come into the FDA reporting system,” known as AERS, or adverse events reporting system, Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research, told journalists in a briefing this morning. Here’s a fact sheet.
The litmus test for making the list includes serious news about a drug; a greater than expected number of adverse events; some new type of adverse event not previously known about or associated with a drug, and something already known that requires a “little further refinement” of FDA knowledge.
However, Dal Pan stressed that the list will not be a comprehensive recital of all drugs with post-marketing safety issues that the FDA is working on. Paul Seligman, associate director of safety policy and communication, added that the review work conducted by the FDA isn’t new, but the effort to alert the public at such an early stage hasn’t been undertaken previously.
How pharma and its investors react to this will be interesting. For months, execs have complained the FDA’s focus on safety, which they maintain has resulted in more delays in approvals and outright rejections. By highlighting drugs already on the market, but not previously identified as problematic, is likely to cause still more consternation. Not every drug on the first list, for instance, has previously been the subject of a public health advisory or some other FDA communication.
Piper
This sounds helpful….everyone on Cymbalta can monitor their bladder behavior now.
Justice in Michigan
FDA’s criteria as summarized: “…serious news about a drug; a greater than expected number of adverse events; some new type of adverse event not previously known about or associated with a drug, and something already known that requires a “little further refinement” of FDA knowledge.”
Interesting to note that almost all of these are far less restrictive than the new CBE threshholds for companies issuing warnings independent of prior FDA consultation.
To me, it is reminiscent of Dan Troy routing warning letters through his office. The result appears to have been a precipitous decline in the number of letters or letters sent out too late to make any difference.
So one must ask: Will this initiative add accessible to safety info or reduce it?
Anne
Bladder retention? What about diabetes, hyperglycemia, and death; homicide and suicide? The FDA’s Medguide system is so feeble that it doesn’t even include any of the atypicals.
Same old, same old, FDA.
Salmon
No. This is the new FDA.
Ignore safety signals prior to marketing.
Raise the bar for putting things into labeling initially even higher, 5% and double placebo. (Gee Vytorin’s cancer risk would just miss this 4.9% and 2.5%).
Comminicate to the public that they have to realize that drugs aren’t safe and that we have to wait until post marketing. As John Senior the reviewer who let Lotronex on the market said to a conference in Italy. We can’t call a drug toxic that we knows kills 1 in 10,000 people. (Wait but we only know about 10% of the deaths so that’s really 1 in 1000 who are killed, and what about the other 9 people who were maimed or seriously injured but didn’t die.)
When there is a post marketing signal, deny, deny, deny, delay, delay, delay (this is old FDA too).
Require a confirmed cause and effect. But doesn’t that require an experiment where you can control all variables and change one factor at a time, and isn’t that why we call them drug studies and not experiments because you can’t control all the variables.
Wait until the companies have developed a test for the side effect or genetic predisposition to it so you can have required drug-device comarketing.
Make sure we have preemption.
And to conclude by summarizing what Dr. Von Eschenbach said in a speech about the new FDA. ‘Change, change, change, change, change, change, change, change, change, change. He just didn’t say change to what.
Salmon
Just A Thought
I was all excited to see Dilantin there- until I clicked the link and found Injectable Dilantin. No mention of the “New Look” 100mg capsules.
I have no faith anymore.
Preempt that.
anita
I’ve heard of suicidal tendencies with cymbalta, yet its still given out too patients with suicidal attempts previous too filling the prescribed medication.
vince
The FDA has considered itself a partner rather than a regulator of industry for quite some time. It often overrules its own staff; to approve drugs . This plus preemption……
gomailcanada
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