> What Invega is Known For


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Side Effects | Invega Index | Consumer Reviews & Comments
Return to the Invega Page

Why Don’t They Just Make Planes out of Black Boxes?

This is the stuff you actually need to be concerned about if you are currently taking, or considering taking, a medication. The black box 1 and other warnings are side effects that can be especially hazardous, if not fatal. These are often, but not always, what a med is most notorious for, e.g. The Lamictal Rash is a black box warning.

If a drug has a black box warning then a verbatim copy of it from its full US PI sheet will be here. We may comment on any black box warning. E.g. Translate doctorese, note just how rare the problem is, or how the warning is the result of the nexus of panic and politics. Any other warnings of note, the pregnancy category, and comments about them, will go here as well. As with Invega’s side effects, if you want to see them all, you’ll need to read the PI sheet. If you want to be paranoid pharmacophobic thorough, check Summary of Product Characteristics (SPCs) or other PI-equivalents we’ve found from other countries on the page of allegedly useful links. The US PI sheets have all the warnings you need to be actually concerned about, but once in awhile one will show up in some commie country on an overseas SPC before a PI sheet.

Black Box Warnings

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS

WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. INVEGA® (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis. [

Black Box Comments

Invega (paliperidone) Other Warnings & Things to Worry About

For all warnings, contraindications, etc., see the Invega (paliperidone) PI sheet.


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Invega (paliperidone) Pregnancy Category

C-Use with caution

Pregnancy Category Comments

What Do the Pregnancy Categories Mean?

Pregnancy categories A, B, C, D, and X are used to quantify both risk and the risk-to-benefit ratio. They are relatively neutral when it comes to severity of birth defects.

The only difference between categories A and B is that the drug companies conducted human trials to get that A rating, while the B rating means there has been no reported birth defect of any kind since the drug has been on the market. With both A and B, no matter how much of either med researchers give to critters, their cute little babies are just fine. Until dissected to prove there is no problem.

Category X is fairly straight-forward. You take this drug while pregnant, possibly pregnant, or potentially pregnant, your kid will be born with three arms and a total of two fingers. There are also plenty of alternatives available. So unless you’ve tried absolutely everything else already, and you insist on damning some innocent child to the same brain cooties that you have, talk to your doctor about another med.

It’s the meds that are categories C and D are difficult. C means animals gave birth to mutants when given anywhere from sub-therapeutic to ridiculously high amounts of the medication in question, and there have been reports of human birth defects that may be to probably are2 due to taking the med. Sometimes the data from the field are so vague (e.g. all or almost all the women were taking at least one other medication), and the critters didn’t spawn Roger Cormanesque offspring on anything lower than 50 times the maximum human dosage, that it’s pushing a C+ to B-. The important thing is category C meds are first-line drugs while category D meds are often, but not always, second- or third-line drugs.

For more information, see the Federal Regulations covering PI sheets and the FDA’s Summary of Proposed Rule on Pregnancy and Lactation Labeling. They’re both remarkably clear for legal / bureaucratic documents. Doubly so considering the FDA published them.


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Drug-Drug, Drug-Supplement, Drug-Food Interactions

Most drug-whatever interactions involve elimination metabolism. With crazy meds the best known example is Lamictal and Depakote or whichever flavor of carbamazepine you’re taking. If you’re taking Depakote you need to take less Lamictal less often. With Tegretol or Equetro you need to take more Lamictal more often. That’s not always the case. Interactions can affect transformation, which is why Paxil + tamoxifen = that breast cancer isn’t going anywhere, because tamoxifen itself doesn’t do shit, your liver turns it into endoxifen (and perhaps others), which does all the dirty work. Interactions can also be potentiations, where one drug enhances the effect of another without slowing its clearance. All patient information leaflets and drug-drug interaction checkers have boilerplate potentiation interactions along the lines of, “two or more antidepressants meds can make you extra drowsy/spacey/ready to go on a tri-state multicide spree.” Alcohol potentiates the sedative effects of TCAs, while alcohol and benzodiazepines potentiate each other3. There can be interactions that are beneficial, and those rarely show up in PI sheets or drug-drug interaction checkers.

Noted Drug-Whatever Interactions

Check for Drug-Drug-Drug Interactions

Drugs.com’s drug-drug and drug-food interaction checker

It’s always a good idea to check for drug-drug interactions yourself. Just because most people in the crazy meds business know about really important interactions (e.g. MAOIs and a lot of stuff, warfarin and everything on the planet) doesn’t mean the person who prescribed your meds told you about them, or the pharmacist has all the meds you take at their fingertips like they’re supposed to. Or they have the time to do their jobs properly when not dealing with complete idiots or playing Angry Farmers on the Faecesbooks.



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References

Invega’s Full US Prescribing Information

Poore, Jerod. “Lamictal (lamotrigine): a review of the literature and consumer experience. Highlighting its use, adverse events, and pharmacology from the educated consumers’ perspective.” Crazymeds www.crazymeds.us (2014).

“Code of Federal Regulations Title 21 PART 201 — LABELING Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin” U.S. Food and Drug Administration website Last accessed 16 July 2014

“Summary of Proposed Rule on Pregnancy and Lactation Labeling” Last Updated: 11/12/2009 U.S. Food and Drug Administration website Last accessed 16 July 2014

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Side Effects | Invega Index | Consumer Reviews & Comments


1 Called "black box warnings" because they appear in a box at the top of the PI sheets, written in big, bold print, and originally surrounded by a thick, black outline. Some companies still put black box warnings in a black box. There is no relationship to the black boxes in airplanes, although I haven't tried burning a number of different PI sheets to see if the black box warnings are still legible in the ashes.

2 Don't expect the drug companies to always cooperate in figuring out where on that scale their meds are.

3 Or: Alcohol + TCAs = Die like a 1960s trophy wife. Alcohol + Benzos = Die like a rock star.


If you have any questions not answered here, please see the Crazymeds Invega discussion board. We welcome criticisms of the articles, notifications of bad links, site problems, consumer experiences with medications, etc. I’m not always able to write back. Hence I never answer questions about meds via e-mail that are answered by this or other articles. Especially if they have been repeatedly asked on the forum. That’s why we write these damn things. Questions about which meds are best for your condition should also be asked on the forum; because this is a free site, so the price of admission is making things easier for somebody else searching for the same answer. We don’t deal with children on the forum or in private because after doing this for ten years I don’t have the emotional stamina to deal with kids who have brain cooties. How to contact Crazymeds. — Jerod Poore, CME, Publisher crazymeds.us


Last modified on Tuesday, 24 September, 2013 at 18:06:47 by JerodPoorePage Authors , Jerod PooreDate created 10 June 2011 at 17:09:23
“What Invega is Known For” by girrl88 is copyright © 2011 girrl88Published online 2011/06/10
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Invega, and all other drug names on this page and used throughout the site, are a trademark of someone else.

will probably have the name of the manufacturer and trademark owner (they’re not always the same company) at or near the very bottom. Or ask Google who the owner is. The way pharmaceutical companies buy each other and swap products like Monopoly™ real estate, the ownership of the trademark may have changed without my noticing. It may of changed hands by the time you finished reading this article.




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Almost all of the material on this site is by Jerod Poore and is copyright © 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, and 2014 Jerod Poore. Except, of course, the PI sheets - those are the property of the drug companies who developed the drugs the sheets are about - and any documents that are written by other people which may be posted to this site will remain the property of the original authors. You cannot reproduce this page or any other material on this site outside of the boundaries of fair use copying without the express permission of the copyright holder. That’s usually me, so just ask first. That means if want to print out a few pages to take to your doctor, therapist, counselor, support group, non-understanding family members or something like that - then that’s OK to just do. Go for it! Please. As long as you include this copyright notice and something along the lines of following disclaimer, I’m usually cool with it.



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1 While there are plenty of books to help you with hypochondria, for some reason there’s not much in the way of websites. Then again, staying off of the Internet is a large part of curing/managing the disorder.

2 Remember kids, Microsloth operating systems are like TOS Star Trek movies with in that every other one sucks way, way more. With TOS Star Trek movies you don’t want to bother watching the odd-numbered ones. With Microsloth OS you don’t want to buy and install the even-numbered ones. Anyone who remembers ME and Vista knows what I mean.

3 Have I mentioned how open source operating systems for commercial applications is one of the dumbest ideas in the history of dumb ideas? I don’t even need my big-ass rant any more. Heartbleed has made my case for me. And that’s just the one that got all the media attention. The very nature of an open source operating system makes security as much of an illusion of anonymity. Before you flip out too much: the domain Crazymeds is hosted on uses a version of SSL that is not affected by the Heartbleed bug. That’s one of the many reasons why I pay a lot of money and keep this site on Lunarpages.

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