September 15, 2009

Pristiq Gets New Warnings Over Hypertension, Sexual Dysfunction

The FDA today put out a list of drugs for which it ordered new warnings and other labeling changes in August. Among the drugs was Pristiq, Wyeth's newish anti-depressant that is a metabolite of Effexor.

Under "warnings" on the drug's package insert, the agency ordered the following update:

"Elevated Blood Pressure:

"Has occurred with Pristiq. hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment."

Under "adverse reactions," the agency ordered the following update:

"Clinical Studies Experience:

"Adverse reactions in patients in short-term fixed-dose studies (incidence ≥ 5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

The FDA adverse events database lists four reports of sexual dysfunction to date.

Sounds like yet another lovely anti-depressant.

Posted by Philip Dawdy at September 15, 2009 11:49 AM
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Comments

That adverse events FDA database is a very handy interactive tool, to search for a drug someone has taken, see events reported and with key words, thanks for that link. Found some scary adverse reactions listed for clozaril, zyprexa and abilify with 'psychosis' as a search word.

Posted by: Stephany at September 15, 2009 12:50 PM

Stephany,
Can you provide a link to the database? I can't find it on their site. I find lots of pages related to it, but can't seem to find the database itself. Or, if I have, I don't recognize it as such.

TIA,
Sherry

Posted by: Sherry at September 15, 2009 05:34 PM

Maybe Pristiq should consider replacing the wind-up doll in its ads -
http://www.pristiq.com - with this.
NSFW/Not safe for work
http://newsliteimgs.s3.amazonaws.com/090426_windupvib.jpg

Posted by: LOL NSFW at September 16, 2009 05:29 AM

Well, don't expect the psychiatrist to monitor the patient's blood pressure. I was on a hefty dose of Effexor and mine never checked my bp once when I was outpatient or even told me to get it checked. They don't have nurses so they're not going to monitor the patient's bp even though they are putting people on drugs that cause hypertension. However, once a patient is admitted and there are nurses around it will suddenly become important to check the bp every single day. Odd.

Posted by: Lisa at September 16, 2009 10:26 PM

Sexual effects & insomnia, right, to be expected, but "Somnolence"? With an SNRI? Who the hell gets that?

The same people who suffer "weight gain" on SSRIs I bet, i.e., they gained weight because they ate one too many donuts and blamed it on the drug they happened to be taking...

Posted by: Neuroskeptic at September 17, 2009 05:18 AM

"Ask your doctor..." Hmmm, apparently one thing I should ask is "Why didn't you EVER mention anything about BP and Effexor?" This is the first I've heard of this.

Soooo glad I got away from these con artists and their drugs. They're the Bernie Madoffs of the medical profession.

Posted by: Sherry at September 17, 2009 07:30 AM

"I am currently withdrawaling off effexor on my own and I also am experiencing the dizziness, chills, that everyone is describing. I really want to know if anyone has lost the weight that they have gained on this stuff?? I have gained 30 lbs and yet everytime I tried to tell the doctor
I thought it was making me gain weight he just said no it wouldn't affect
my weight. Now I'm depressed because I'm so large. Anyone have any suggestions??"

"I have been on Effexor for over two years now. When starting, I went from a size 3 to a size 13 and continuting getting fatter regardless of how little I eat and how much excersize I get!"

"I have been on Effexor for 13 years and have gained 80 pounds.
I stopped for about one year to try to get back to my normal body weight but found that I could not function without it."

http://www.steadyhealth.com/The_effexor_withdrawals_and_weight_gain_are_my_main_concern_t103944.html

Neuroskeptic,

Do you believe that these people, and many other testimonies that are on the Web, are lying?
Give me a break.
Go to Youtube to see more people making things up.
Yes, we are a bunck of people who likes to create conspiracy theories.
Why care about us? Our words are not heard you can be at peace with you holly bible and keep on researching.

I really don't understand why some people come here to say the obvious: we are all lunatics.
Bye cause I have to take my thorazine..oh my God! Father how are you today? Your beard seems a little.... no straight jack................


Posted by: Ana at September 17, 2009 01:06 PM

I know a patient who really believes that lithium gave him his bipolar disorder. He's not lying but he's not right.

Posted by: Neuroskeptic at September 17, 2009 06:05 PM

Now if we were talking about mirtazapine, that really does cause weight gain. Jesus. I put on 20 kg on that stuff. But then I started on venlafaxine and lost it again!

Posted by: Neuroskeptic at September 17, 2009 06:15 PM

Yes, it's all in our heads. Just like when Effexor (probably in combination with all the other shit the doc had me on) shut down my bladder. The shrink immediately thought I was making it up. Because patients so often hold their urine all day allowing their bladders to expand to the size of beach balls just so they can have something exciting to tell their shrinks. In fact, I liked to take it to a whole new level. I enjoyed it so much I thought hey, let me writhe in pain and ask to be cathed. That will be cool. The urologist, unlike my shrink, recognized anticholinergic toxicity - fever, tachycardia, urine retention. The urologist told me he was seeing this more and more in patients on these drug cocktails. It's just too bad my shrink was a complete doofus.

I will say the placebo effect of Flomax did help with my pseudo bladder spasms. Going off Effexor cured me of this disorder that was all in my head.

Posted by: Lisa at September 17, 2009 08:34 PM

Neuroskeptic, I didn't gain weight on Remeron so I think you're making it up about gaining weight.


Heck,you judge people by your own experiences so I thought I would do the same to you.


All sarcasm aside, if someone commented they had gained weight on Remeron, would you blame them since you had also? Just curious

Posted by: AA at September 18, 2009 03:10 AM

Wow!!!!!!!!!!!!
As always when we put data even the hateful anecdotal evidence that is part of the 4th phase of clinical trials process, FDA should study it ... they don't answer, they change the subject.

Yes Lisa it's all in our heads!
lol

I'm glad you could get out off Effexor. I tapered for 19 months and 3 months after being off the drug I was in such a state that I had to go back.
Will have to take it till the day I die.
If I miss one dose... chaos.

According to David Healy some people are unable to withdraw.

One of the most funny stories I have is the psychiatrist while I was tapering many drugs:

"Come to my office at 5 p.m. and I will prove to you that it's not withdrawal, it's psychological."

It's funny but this was the person responsible for the Effexor I take. Instead of waiting till the end of the process of all drugs - Paxil included - she decided to put me on Effexor.
I took it.
My fault.

Posted by: Ana at September 18, 2009 04:36 AM

Ana, I understand your decision to go back on Effexor. When I quit the first time, I did it cold turkey and the withdrawal was so bad I went to the ER begging for a refill. Considering my experiences on the drug and with psychiatry, that should tell you how bad the withdrawal was. (I was able to take Effexor at the high doses without the bladder issues, as long as I was also on Flomax which is a drug they give men with prostate issues. I was a twenty something female taking a prostate med, lovely).

This was many years ago, so I didn't know anything really about withdrawal except what I had experienced. It's not like the doctor warned me about it, but I definitely learned my lesson.

Withdrawal from that drug can be awful. It sucks that you have to feel so trapped on this drug. I have heard other people say that, too. Many doctors don't take psych drug side effects and withdrawal issues seriously enough.

I will say, however, to the credit of the psychiatrist who happened to be in the ER the evening I came in begging for relief, he did attribute the vomiting, diarrhea, fever, and dehydration to withdrawal from Effexor. I guess I wasn't the first.

God only knows how much money I wasted over those years not only on the drugs but all the treatment required to address the side effects/withdrawal from the drugs.

In all the years since getting off those drugs, I think the extent of my medication usage has been one bottle of antibiotics for an upper respiratory infection and some steroids to treat fire ant bites. That's pretty much it. When I was under psych care it was a paper bag full every month. No wonder I was crazy.

Posted by: Lisa at September 19, 2009 11:02 PM

Lisa,
"In all the years since getting off those drugs, I think the extent of my medication usage has been one bottle of antibiotics for an upper respiratory infection and some steroids to treat fire ant bites. That's pretty much it. When I was under psych care it was a paper bag full every month. No wonder I was crazy."

Yeah! I now take one thyroid pill per day. No more of those horrible little plastic daily pill strips. No more paper bags. No more sinus infections, either. My lifelong sinus problems have disappeared in the 2.5 years I've finally been treated for hypothyroidism.

I could have worn a tee shirt that said "This woman is HYPOTHRYOID, Idiot!" and the psychiatrists (and, to be fair, PCPs) would have missed it. My laundry list of symptoms were brushed off for 25 years. A pox on their houses.

Posted by: Sherry at September 21, 2009 11:25 AM
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