Vytorin Got You Down? There’s Good Reason
6 CommentsBy Ed Silverman // February 14th, 2008 // 5:36 pm
The pill, not just the controversy, can have that affect on you. The FDA has just approved a labeling change for the cholesterol med that adds depression as a possible side effect. The same thing goes for Zetia, which along with Zocor comprises the Vytorin combo therapy.
In letters to Schering-Plough and Merck, which jointly market the meds, the agency says depression would be added to the section of the label that discusses adverse reactions in post-marketing and the new language will be included in a section of package inserts listing possible side effects. The section of the label being changed is for adverse reactions regardless of the “causality assessment.”
Here is the letter to Merck and here is the letter to Schering-Plough. This is the new Vytorin label.
A Merck spokesman told Dow Jones that the changes were made based on reports of depression by patients, which the drugmakers forwarded to the FDA, and caused them to submit proposed label changes in October.
Justice in Michigan
A few questions:
Dow Jones reports that the company submitted the reports “volunatarily.” Legally, did they have a choice? What are the criteria for reporting depression as a possible AE at this point in the life of the drugs?
As the article reads, the reports (I assume Medwatch or a summary of Medwatch) were submitted along with a proposed label change. Would the reports have been required to have been submitted along the way as well? (Version of first question.)
It appears that FDA took four months to approve label change following submission of info plus proposed label change. These are both blockbuster drugs. How does that strike people as a length of time?
Jack2
Companies face strict, and short time lines in sending all individual adverse event reports to the FDA. Companies also examine the AEs they receive and send periodic reports to the FDA. The laws/policies regulating the timing (quarterly?) and content of these reports (eg. did Merck + SP highlight depression in their report and request the warning?) are not known by me.
Justice in Michigan
Thanks, Jack 2 - I was just trying to get updated. As I recall, the due dates for Medwatch reports gets longer as the drug has been on the market longer, and there are different obligations depending on the seriousness of the potential AE. I also wondered where depression would be ranked in that regard.
Also, as I understand it, FDAAA allows FDA to mandate label changes without the kind of negotiation that was made famous in the Vioxx label change. That said, companies can appeal, so the point may be moot.
If this instance is a typical one, it would suggest that we can expect something like a four-month gap between a company submitting AE data and suggested label change and that change actually being implemented. Here again, I don’t know if a more immediately life threatening (though depression is not trivial…) AE would trigger a quicker change, along with Dear HCP letters, etc.
The lives of 22,000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS Television’s 60 Minutes program. |
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Evelyn Benton
I was taking vytorin and it got me down to where I just wanted to lay down all the time. My memory got really bad and I had problems with my arms and legs. I stopped taking it and the next day my mind was so much clearer and I didn’t want to lay down all the time.