As a relatively young and generally healthy person with very low blood pressure and an extremely low risk of heart attack or stroke, I loved Vioxx: it was the only thing that worked for ankle pain from my old injury and associated post-traumatic arthritis. Ibuprofen does zilcho for it when it’s bad, at least at dosages that aren’t likely to eat my liver – given, those occasions have fortunately rare over the past couple of years, but it took a long time and much trial and error to find something that worked, and now I’m back to Square One. Haven’t tried Celebrex, its main competitor, yet – I guess that’s next, after I use up my precious stash, anyway.
How much are pharmaceutical companies going to babysit doctors in deciding what medications are safe for which patients? And when a drug is pulled, is it immediately gone from the shelves? Or do I maybe have a chance to get a quick refill?
Thanks for the timely thread, Eva Luna! I’d just written an Rx for Vioxx this very morning, and noting your thread and link, quickly changed it to Celebrex!
The SDMB! Used by more prison doctors (well, at least one) to keep current!
I read about this and let me tell you it was some craptacular news to wake up to. I don’t take Vioxx often, and my heart is in good shape. I’m so pissed, I’m not at risk, yet because of a small group I can’t get a medicine that actually works. I’m extra screwed because Celebrex didn’t work out for me at all (I’d have to look at my records to see why exactly; it could’ve been anything: rash, trouble breathing, didn’t work, skin turned green, the usual). As it stands, I feel like I’m constantly bombarded by: Are you taking this medication? Call our law office immeeeeeeeeediately commercials. Hell, I take half of the meds I’ve seen in commercials. My doctors and I talk about pros and cons and we make decisions based on what’s best for me. I agree that medical companies should stop babysitting doctors. So pissed off, so filled with rage-o-hol. First Soma is taken away (the name always amused me), and the main alternative my doctors gave me would make me pass out suddenly. Sure, my family got some funny stories out of it, but I have yet to find a muscle relaxer that works as well and now this. Barnacles! Barnacles I tell you!
Nope, but then it’s been a while since I needed to fill my prescription - my ankle has been pretty well-behaved lately, thanks to a genius of a foot-and-ankle specialist and a pair of prescription orthotics. And Vioxx worked just fine, so I didn’t see the need to try anything else. (That, and my sister once had a nasty reaction to Celebrex, and we tend to be pretty similar in that department.)
I fail to see what the FDA has to do with this one - AFAIK the manufacturer is yanking it voluntarily, not at the behest of the FDA.
And as for class-action trial lawyers…well, there would be no case without enough plaintiffs to make up a class. But then that’s a whole different thread.
I don’t know…I just transferred into the Regulatory Affairs group of the pharmaceutical company I work for. Since I don’t know much about FDA Regs, I’ve been taking some training. Yes it is a voluntary recall, but I see it as “voluntary”. They aren’t legally required to yank it, but you can be sure that the FDA will be on their asses, and it’s probably more of a preemptive action than anything else.
Vioxx’s press release here (warning: pdf). It’s simply not a safe drug, in their estimation, so they’re pulling it voluntarily.
Celecoxib (Celebrex) is the closest drug out there to Rofecoxib (Vioxx). I hope your doctor and you find something to work for you.
I had to dig through all of my cupboards at work today to make sure we had no Vioxx hiding anywhere. I found scads of the stuff to be sent back to the manufacturer - I work in a hospital pharmacy. (Well, today was my last day until after the baby’s born, but still.)
Maybe the recall was “voluntary.” But it’s still aggravating. Vioxx is also used in lots of other ways than for long-term therapy in people at risk for heart attack or stroke or cardiovascular problems: people like me, or people who need to use it for brief periods for other reasons (my sister used to work in an oral surgery practice, and the doctors prescribed it a lot for pre- and post-surgical pain relief). And believe me, I’m a drug minimalist; I don’t take anything without good reason, and 18 months is a long time to be taking anything. It seems that’s why the cardiovascular symptoms didn’t show up in significant numbers in Vioxx users until now.
There is a reason the FDA approved it to begin with; it works well for some people who shouldn’t be taking other NSAIDs, and heck, even aspirin is dangerous if used inappropriately. There are plenty of drugs out there that are dangerous if used inappropriately; that’s why they require prescriptions. I’m just aggravated that the choice to prescribe Vioxx has now been taken away from my doctor, even though the circumstances in which it has now been found to be potentially dangerous still leave huge numbers of people who could benefit from it.
Eva, I hear you on this whole thing. I mean, it’s a multi-billion dollar drug. Which means there are lots of people like you who have been enjoying what the drug does for them.
And now they are all wondering what the hell to do next.
According to your article, the FDA has been closely monitoring the company and its drug. Imagine that I were monitoring you, that people were beginning to complain about you, and that, upon anything that I had deemed a violation, I had the power to fine you a considerable sum of money. Now, imagine that a big chunk of my income comes from fining people like you. Do you see how the company might have been just a mite on edge, and decided to err on the side of caution?
Sure, I can see why Merck erred on the side of caution, but I’m very, very sorry that they did.
But to put it mildly, I don’t attribute any nefarious motives to the FDA in this instance. I’m no epidemiologist, but unless someone can point out a flaw in the studies which have shown an increased incidence of adverse cardiological effects in long-term Vioxx users, I have no issue with the FDA showing concern and/or keeping a close eye on how the drug is marketed. We’re not talking about people merely “complaining;” we’re talking about heart attacks and strokes here. I have no issue with the government wanting to keep close tabs on the use of an item which has the potential to kill people, but as I mentioned before, tons of prescription drugs can kill people if used inappropriately, as well as all sorts of OTC drugs. Hell, Viagra can kill people if used inappropriately, and I consider y ability to walk properly and in a pain-free manner at least as important as a man’s ability to get an erection. And so far, nobody’s talking about yanking Viagra.
There were already large categories of people who were contraindicated from using Vioxx (people with certain liver and kidney problems, among other things), but those contraindications were clearly labeled in the literature provided to patients and doctors. I just wish Merck had gone that route this time, rather than yanking the drug entirely.
They probably do, too. They probably wish it were still turning them a profit. I appreciate your point, but you must understand how heavy they perceive the disincentives to be. No CEO stops sales unless there is something ominous underfoot.
Perhaps they were balancing the disincentives against the fact that hope to have a second-generation drug coming out relatively soon which should counterbalance some of the lost sales. That, and how much more time did Vioxx have in-patent anyway?
