Adverse Events Reports Mount For Pristiq
Some of you remember that last year the FDA approved Wyeth’s new anti-depressant Pristiq for use in depression. The drug is a metabolite of Wyeth’s soon-to-go-off-patent Effexor, so it’s essentially old wine in a new bottle. At the time, Tufts University psychiatrist Danny Carlat was quite critical of the drug on his blog, especially over the drug’s slim effectiveness.
Last June, a Wyeth executive even publicly admitted that the company expected the drug to have withdrawal problems, much as Effexor does. Ever since, I’ve been getting sporadic reports of problems with the drug from people who’ve taken it, including two late last week which I reproduced below.
To put this in perspective, Pristiq was approved early in 2008 and has already generated 1,272 adverse events reports to the FDA through the end of 2008. That’s a lot in such a short period of time, especially considering that this drug isn’t exactly widely used. The company didn’t even detail Pristiq’s 2008 sales in its press release on its 2008 results, so it’s obvious that sales were small (Effexor, however, sold $3.9 billion in 2008). The company also didn’t detail Pristiq sales for the first quarter of 2009.
It’s discouraging that 17 of those reports involve completed suicides through the end of 2008. There are also 48 reports of suicidal ideation through the end of 2008. Other reported side effects through the end of 2008 include nausea, dizziness, confusion, tremor, drug-induced mania and so on.
It sounds like Wyeth has another winner on its hands.
Meanwhile, here are two recent patient comments on the drug:
“I took Pristiq for 8 days and while I started to feel better from my minor depression, my blood pressure went through the roof so I had to stop taking it. I am on day 3 off of it and I can barely function and that’s after taking it only for 8 days. I was told I didn’t have to taper off because I was only taking 50 mg and for such a short amount of time. I am dizzy, nauseous, can’t stop crying, having suicidal thoughts and basically uncontrollable emotionally. I never imagined I would suffer so much coming off of it after only taking it for 8 days. This medicine should not be sold. It hurts more than it helps. I pray this goes away soon before I lose everything that matters to me.”
I hope it goes away too. It’s worth noting that high blood pressure has turned out to be one of the main problems associated with Effexor.
Here’s another patient:
“Pristiq seemed to work for my depression but I went off of it (and went through the horrible w/d sxs!) because I am trying to ‘de-chemical’ my life. I went through neurofeedback and thought I could go off of Pristiq safely. Wrong.
“So now I am thinking of going back on it. The body aches, depression and lack of motivation for ANY activity may be worse than the thought of being on a chemical.
“But then again, I hate that we don’t know what these chemicals actually do to our brains!!
“I am between a rock and a hard, hard place.”
I hope this person is able to resolve whatever withdrawal symptoms they are experiencing without going back on the drug, as that’s how people turned into anti-depressant junkies for life. Or become physically-dependent, if you prefer.
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