1. 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 paranoidpharmacophobic 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.
2. 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. [
3. Black Box Comments
4. Invega (paliperidone) Other Warnings & Things to Worry About
For all warnings, contraindications, etc., see the Invega (paliperidone)PI sheet.
5. Invega (paliperidone) Pregnancy Category
C-Use with caution
5.1 Pregnancy Category Comments
5.2 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.
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.
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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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.
Date created 10 June 2011 at 17:09:23 Page Author: girrl88 Last edited by: JerodPoore on 2014–03–08
Invega (paliperidone) Black Box Warnings, Notable Traits & Effects by girrl88 is copyright 2011 girrl88
All rights reserved. No warranty is expressed or implied in this information. Consult one or more doctors and/or pharmacists before taking, or changing how you take any neurological and/or psychiatric medication. Your mileage may vary. What happened to us won’t necessarily happen to you. If you still have questions about a medication or condition that were not answered on any of the pages you read, please ask them on Crazy Talk: the Crazymeds Forum.
The information on Crazymeds pertains to and is intended for adults. While some information about children and adolescents is occasionally presented (e.g. US FDA approvals), pediatric-specific data such as dosages, side effects, off-label applications, etc. are rarely included in the articles on drugs or discussed on the forum. If you are looking for information regarding meds for children you’ll have to go somewhere else. Know your sources! Nobody on this site is a doctor, a therapist, or a pharmacist. We don’t portray them either here or on TV. Only doctors can diagnose and treat an illness. While it’s not as bad as it used to be, some doctors still get pissed off by patients who know too much about medications, so tread lightly when and where appropriate. Diagnosing yourself from a website is like defending yourself in court, you suddenly have a fool for a doctor. Don’t be a cyberchondriac, thinking you have every disease you see a website about, or that you’ll get every side effect from every medication1. Self-prescribing is as dangerous as buying meds from fraudulent online pharmacies that promise you medications without prescriptions.
All information on this site has been obtained through our personal experience and the experiences family, friends, what people have reported on various reputable sites all over teh intergoogles, the medications’ product information / summary of product characteristic (PI/SPC) sheets, and from sources that are referenced throughout the site. As such the information presented here is not intended as a substitute for real medical advice from your real doctor, just a compliment to it. You should never, ever, replace what a real doctor tells you with something from a website on the Internet. The farthest you should ever take it is getting a second opinion from another real doctor. Educate yourself - always read the PI/SPC sheet or patient information leaflet (PIL) that comes with your medications and never ever throw them away.
Crazymeds is not responsible for the content of sites we provide links to. We like them, or they’re paid advertisements, or they’re something else we think you should read to help you make an informed decision about a particular med. Sometimes they’re more than one of those things. But what’s on those sites is their business, not ours.
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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 Internetis 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?
[begin rant] I rent a dedicated server for Crazymeds. It’s sitting on a rack somewhere in Southern California along with a bunch of other servers that other people have rented. The hardware is identical, but no two machines have exactly the same operating systems. I don’t even need to see what is on any of the others to know this. If somebody got their server at the exact same time, with the exact same features as I did, I’m confident that there would be noticeable differences in some aspects of the operating systems. So what does this mean? For one thing it means that no two computers in the same office of a single company have the same operating system, and the techs can spend hours figuring out what the fuck the problem could be based on that alone. It also means that application software like IP board that runs the forum here has to have so many fucking user-configurable bells and whistles that even when I read the manual I can’t find every setting, or every location that every flag needs to be set in order for a feature to run the way I want it to run. And in the real world it means you can get an MBA not only with an emphasis on resource planning, but with an emphasis on using SAP - a piece of software so complex there are now college programs on how to use it. You might think, “But don’t people learn how to use Photoshop or Adobe Illustrator in college?” Sure, in order to create stuff. And in a way you’re creating stuff with SAP. But do you get a Bachelor of Fine Arts degree with an emphasis on Photoshop?
Back in the Big Iron Age the operating systems were proprietary, and every computer that took up an entire room with a raised floor and HVAC system, and had less storage and processing power than an iPhone, had the same operating system as every other one, give or take a release level. But when a company bought application software like SAP, they also got the source code, which was usually documented and written in a way to make it easy to modify the hell out of it. Why? Because accounting principles may be the same the world over, and tax laws the same across each country and state, but no two companies have the same format for their reports, invoices, purchase orders and so forth. Standards existed and were universally ignored. If something went wrong it went wrong the same way for everyone, and was easy to track down. People didn’t need to take a college course to learn how to use a piece of software.
I’m not against the open source concept entirely. Back then all the programmers read the same magazines, so we all had the same homebrew utilities. We even had a forerunner of QR Code to scan the longer source code. Software vendors and computer manufacturers sponsored conventions so we could, among other things, swap recipes for such add-ons and utilities. While those things would make our lives easier, they had nothing to do with critical functions of the operating system. Unless badly implemented they would rarely cause key application software to crash and burn. Whereas today, with open source everything, who the hell knows what could be responsible some part of a system failing. [/end rant]