Talk:Boxed warning

The Rule in Practice

"The Rule in Practice" section needs to be cleaned up and cited... was this written by a doctor or are there published sources to back this up, besides the one external link on this page? Moushi 22:08, 14 January 2007 (UTC)

links are not working

I tested out 6&7 and they don't work.--scuro (talk) 19:44, 23 September 2008 (UTC)

This article could use a picture

Surely a picture wouldn't be too hard to create, and it would add a much-needed visual element to what is a pretty dry wall of text. Badger Drink (talk) 08:06, 1 December 2009 (UTC)

Additional examples

natalizumab —Preceding unsigned comment added by Acgator09 (talk • contribs) 02:25, 17 May 2010 (UTC)

  -- I was also looking for natalizumab in the examples section, so I added it.  Please let me know if there are any errors in my submission.  Schlice (talk) 17:43, 8 September 2016 (UTC)

Changing the title of this page

The FDA uses the term "Boxed Warning" to describe the subject at hand - that is its official title. The term "black box warning" is a sensational phrase, commonly used by the lay-press to convey a sinister meaning (like "black magic" or "black lie" do). Rather than using the sensational term as the title, and giving brief mention to other names including "boxed warning," I propose that it would be more appropriate to rename the page "Boxed Warning," and then give the colloquial names their due mention subsequently. DoctorEric (talk) 02:49, 16 September 2011 (UTC)

I agree that we should use the official term and have a redirect from more collaquial terms to the official term. We can also have a brief discussion of the issue on the page. I will note that FDA has used the term "black box warning" in some of their discussions (See [1]) but it does appear that "Boxed Warnings" is the more official term. Remember (talk) 11:57, 16 September 2011 (UTC)

Wikipedia's rule is in most cases to use the name by which an article's subject is most commonly known, which is not necessarily the same as the name as authorities would use. 121a0012 (talk) 20:26, 22 October 2011 (UTC)

I disagree with your assertion. As a test, I looked up another medical term by its common name, "partial-birth abortion," and was redirected to the Intact dilation and extraction page (I don't know anyone who uses THAT term! But it is the correct name of the procedure, just as "Boxed Warning" is the correct name for the topic at hand). DoctorEric (talk) 02:48, 1 November 2011 (UTC)

The title has been changed, as proposed last year, and the text within the article cleaned up to reflect that change. There are still plenty of minor problems with the article (mostly flow) that I'll leave to others to clean up. DoctorEric (talk) 22:52, 30 January 2012 (UTC)

List of drugs with boxed warnings

Parasbuy22 just added a list of drugs with boxed warnings. I removed it. The immediate problem was that no reference was provided to verify the information. This might be useful information if a source was provided to confirm this and especially if there are other sources which give commentary on the list, but before adding this the sources should be identified. It might be best for this list to go in its own article and for this article to link to the list. Blue Rasberry (talk) 14:10, 27 March 2014 (UTC)

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American or global?

The term 'boxed warning' is unclear. The article is not global. This article should not open with 'in the United States' or needs its named changed, or the 'in other jurisdication' section should be split into its own article. I am unsure if this should be rewritten to be about the global concept of warnings in drug labels and package or safety information on drug labels (to use some phrasing from cited sources) or if we need to create a new article, but the way this is written right now is just bad. _{Piotr Konieczny aka Prokonsul Piotrus| reply here} 03:23, 12 December 2023 (UTC)

General information about warnings and safety belong in Medication package insert#Sections of the Prescribing Information. There isn't much to say: The first thing to say is that they exist. The second thing to say is that legal department of pharma companies want every possible side effect warned against in the US, and the FDA restricts them to listing only those things that can be proven to the FDA's satisfaction to be real. (The lawyers want this so that they can respond to Product liability lawsuits with "We officially told you that there was a risk that your skin would turn bright blue on alternate Tuesdays, so we aren't liable".) There isn't much else to say about it. WhatamIdoing (talk) 20:36, 12 December 2023 (UTC)

Several of the "other countries" aren't related to this subject at all. I removed two countries, and it's possible that the others need to be removed as well. This really is a US-specific subject. WhatamIdoing (talk) 20:38, 12 December 2023 (UTC)

"This really is a US-specific subject." Agree. Appropriate to See also/main article/broader Medication package insert. I'm adding it. RudolfoMD (talk) 22:38, 19 December 2023 (UTC)

Image

Is this relevant? File:Front of a box of ammonia inhalants.jpg. For global stuff: File:Autoinjector with Trulicity by Lilly (Dulaglutid)-3129.jpg may have some symbol of relevance? _{Piotr Konieczny aka Prokonsul Piotrus| reply here} 03:36, 12 December 2023 (UTC)

No, those pictures aren't relevant. A boxed warning is printed on the Medication package insert. It usually looks like this:

The 500 mcg/mL strength product should be diluted prior to use in an appropriate solution.

(This example is from XGen Pharmaceuticals' injectable clonidine formulation.) WhatamIdoing (talk) 20:32, 12 December 2023 (UTC)

https://www.fda.gov/media/96657/download?attachment, pages 45 and 46 (bottom) have examples, former w/ context. And Template:PD-USGov applies. RudolfoMD (talk) 03:52, 14 December 2023 (UTC)

@Piotrus How are those? Should we include the whole slide or just the box itself, with a bit of margin? RudolfoMD (talk) 04:02, 21 December 2023 (UTC)

@RudolfoMD Seems good but I am no expert here, @WhatamIdoing - what do you think? _{Piotr Konieczny aka Prokonsul Piotrus| reply here} 09:49, 21 December 2023 (UTC)

Piotrus, WhatamIdoing, and RudolfoMD, I uploaded an image to Commons several hours ago of a boxed warning issued by the FDA. Is the image sufficient enough? — B. L. I. R. 17:36, 21 December 2023 (UTC)

@BeywheelzLetItRip, that looks okay to me. Do you want to add it to the article yourself? WhatamIdoing (talk) 18:27, 21 December 2023 (UTC)

 Done It should be there now. — B. L. I. R. 18:49, 21 December 2023 (UTC)

@BeywheelzLetItRip Thank you. Any chance we get get freely licence photo of this in practice (3D, in the box?). _{Piotr Konieczny aka Prokonsul Piotrus| reply here} 03:07, 22 December 2023 (UTC)

I think that Acetaminophen (e.g, Tylenol) would be the most accessible product for getting a photo. If it's on the outside of the box, I might be able to get a photo the next time I'm in a drug store. WhatamIdoing (talk) 06:11, 23 December 2023 (UTC)

A Tylenol box or bottle is

1. copyrighted. So a photo would not be free, surely.
2. doesn't have a boxed warning on it. It's in the insert.

If I'm not mistaken, https://commons.wikimedia.org/wiki/File:Boxed_warning.svg is mis-tagged and not PD. RudolfoMD (talk) 01:30, 24 December 2023 (UTC)

Copyright is complicated. That image was taken from an FDA document, so it might be public domain. AIUI the appearance of the boxed warning itself is too simple (uncreative) to be eligible for copyright, but it's possible that the text would be eligible for copyright if it were written by the manufacturer and not dictated by the FDA. I don't know how likely that is. ¯\_(ツ)_/¯ WhatamIdoing (talk) 04:43, 24 December 2023 (UTC)

Exactly. Even if we knew FDA wrote it (and we don't), point 2 makes it a non-starter. RudolfoMD (talk) 21:37, 24 December 2023 (UTC)

How about reproducing it ourselves, similar to the example above? Is this text copyrightable? _{Piotr Konieczny aka Prokonsul Piotrus| reply here} 12:22, 26 December 2023 (UTC)

The appearance itself is not copyrightable. There is a chance that the text is copyrighted. WhatamIdoing (talk) 17:04, 26 December 2023 (UTC)

I'm noticing that "suicide" only appears in a parenthetical. My money is on the pharmaceutical company being the author.

I think the example I pointed to is better. I'm thinking the image should be of most of the slide, enough to show the box in context, not just the box itself. Thoughts?

It's better to feature FDA-written exemplary language, IMO. RudolfoMD (talk) 19:13, 26 December 2023 (UTC)

Right, that would surely be PD. _{Piotr Konieczny aka Prokonsul Piotrus| reply here} 03:03, 27 December 2023 (UTC)