In textbooks, manuals, and some types of web writing, boldface is often used to highlight the first instance of an important keyword that is central to the subject of a chapter or article. (1)
I guess we can now say, with confidence, that this also applies to warning labels for SSRIs.
Let's just take a look at the current Patient Information Leaflet (PIL) for Seroxat, which was last revised on 11 January 2017.
**Seroxat is the European brand name for paroxetine. In the US and Canada the brand name used is Paxil.
Click to enlarge
Well, according to the description quoted at the head of this blog post, "boldface is often used to highlight the first instance of an important keyword that is central to the subject of a chapter or article."
So, the 2017 warning label clearly shows that it's important for patients and healthcare professionals to know that the current paroxetine label emphasizes that being a young adult puts you at an increased risk of suicidal behaviour whilst taking antidepressants. Remember, this is taken from the current Seroxat (Paxil) PIL.
Why do we not see the same for all adults?
Also, whose idea was it to use boldface on the words "young adult"?
This is something I put to the MHRA Pharmacovigilance team:
Could you please explain why "young adult" is in boldface type font and who made the decision to include "young adult" in a boldface type font?
It's important to note, before I publish their response, that MAH stands for Market Authorisation Holder which, in essence, means the manufacturer of the product.
Below is the answer MHRA sent. Please note: MHRA's punctuation and spelling errors are as received. Ironically, my post today is about the importance of words used in drug labeling--words the MHRA accepted. Given that the MHRA doesn't take the time to check its own correspondence, they likely apply the same carelessness when approving drug company's labels.
MHRA's haphazardness is unprofessional; But the former (MHRA's letters) simply make their communications department look bad, while the latter (MHRA's labeling) is extremely hazardous to consumers...
Wednesday, April 5, 2017
Dear Mr Fiddaman
The SPC for Seroxat includes the following:
A meta‑analysis of placebo‑controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old (see also section 5.1).
As the above suggests that this particular age group are most at risk, the MAH will have suggested the emboldening of the text within the PIL. There are fors and againsts the use of emboldening, but in this particular case it has been considered appropriate.
--
I asked for further confirmation of this and was told...
Thursday, April 6, 2017
Dear Mr Fiddaman,
The emboldening would have been proposed by the MAH, who is this case are Smithkleine Beecham limited (part of the GSK group).
Kind regards,
--
So, there you have it folks. GlaxoSmithKline suggested that words "young adults" be highlighted in boldface font. As you will see from the current Seroxat Patient Information Leaflet there is no such boldface font for adults over the age of 24.
Surely, the FDA (the American drug regulator) would have also been in the same position as the MHRA, right? Did GlaxoSmithKline also suggest to the FDA that they should boldface the words "young adults"? If so, why didn't GlaxoSmithKline suggest the same for adults over the age of 24 given that the rate of suicidal behavior for adults over 24 taking Paxil showed a nearly 9-fold increase?
Don't GlaxoSmithKline have a responsibility to protect this patient population from potentially fatal or disabling risks like this?
I'm at a loss here. Who is actually protecting the adult consumers with regard to potential suicide risks with GSK's Paxil?
It appears through all the bickering between GSK and the regulators about which entity is responsible, they've both forgotten that, in the meantime, consumers are still taking a drug that is potentially life-threatening. You cannot stress a warning in boldface to one individual age group and, seemingly, ignore another age group. This is inadequate and misleading to both prescriber and patient, regardless of how GlaxoSmithKline wish to paint it.
The current Paxil warning label shows a distraction from the whole truth, it's procrastination, it's misdirection and it's doublespeak, with the sole aim of hiding the whole truth whilst offering a morsel of truth. It's lying by omission. Magicians and illusionists do the same thing because they don't want to show you how they are conning you, they will draw your attention to one thing whilst hiding another thing (the secret) - This is exactly what GlaxoSmithKline are doing, although they have been clever, they are showing a glimpse of the truth but carefully distracting you away from it by using boldface font.
Now, where have I seen American lawyers representing GSK arguing that warnings for suicide, over the age of 24, have been placed on their labeling, and that those warnings are adequate and not vague? Not vague? I'd suggest this was a boldface lie, or, at the very least, lying by omission.
Bob Fiddaman
(1) Boldface text - grammarist.com
Court transcripts from the Dolin Paxil trial
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