Breaking news : FDA authorises Viagra for children...(this is not a joke)

https://twitter.com/_/status/1678839794955329549

1. Well... i am ALL in for medical progress.
But there is one detail that bugged me here... based on ADULT safety data, FDA declared it also safe for children - between age 1 and 17.
Does this even make sense? This is NOT normal protocol, but here is the full story...

The indication - a form of Pulmonary Hypertension - is very rare.

Checked on the official web site from all clinical trials in the US, they had 6 patients at children age - enrolled in the phase III open table clinical trials.
(See image #1)

To ascertain absence of side effects, one would need 1000's of cases, which are just not there.

So given the paucity of the phase 3 data, what is any decent regulatory agency to do? - to make it CONDITIONAL, which avoids denying some beneficial therapy but at the same time, avoids making things up and do NOT say it is safe!
We just do not know THAT yet... see my problem?

2. What is the situation in children on the field (outside of this phase 3)?

- In a review and meta-analysis of the cases reported to the FDA between November 1997 and December 2009 588 pediatric adverse event reports, including 257 deaths for sildenafil, bosentan, and epoprostenol. (2 other drugs given alone or in combination).

- But because there was a need for better clinical matching (patient specific data), we have this interesting an RELEVANT paper about all of this.
[link to frontiersin.org (secure)]

There were known side effects in children (known for years, that i why this paper is relevant. It confirms the high frequency of side effects of this drug used in children (See image #2). The deaths were linked to high doses - which is NOT a surprise right!
(See Image #4 - extract from PDR - product drug summary usage)

Extract:
"In conclusion, side effects of sildenafil are common in pediatric PAH patients and more common than previously reported. In addition, side effects occur more commonly when used in combination with other therapies for PAH."

Another Hyper-Interesting fact (see in bold):
It was commonly used in off-label in children. This means - that for years - without any clinical trials the product was used in children because the clinical expertise was present. This is exactly the same as HCQ, an off-label BUT logical usage! (le fameux 2 poids- 2 mesures!)

Extract:
"Sildenafil, a phosphodiestase type 5 inhibitor, was approved in 2005 for the treatment of pulmonary arterial hypertension (PAH) in adults and is commonly used off-label for pediatric patients. Little is known, however, about sildenafil’s side effects in this population."

3. Now Sildenafil is better known as Viagra (from Pfizer too!).

- Well... this molecule is known to black PDE5 (phosphodiesterase 5- which increases then cGMP concentrations and then Nitric Oxide...) and because this PDE subtype is mostly present/located in heart tissue but also in the nerves controlling erections... you see why it is effective in Erectile dysfunction.

- This molecule was first selected for improving blood flow for erections in patients with chronic diseases affecting arterial blood flow like diabetes for ex... Well the SIDE effect was ERECTIONS, but it led to some weird heart effects (sudden loss of any blood pressure and deaths during trials), and then the final product was COUNTER-indicated in the initial population it was designed for.

See here a publication from the American Herat Association (AHA) about this very fact -
[link to ahajournals.org (secure)]

Extract from paper:
"Given the increasing reports of deaths in which the use of Viagra may be implicated, clinicians need to exercise caution when advising their patients with heart disease about taking this medication. Specific recommendations regarding sildenafil (Viagra) and the cardiac patient are summarized in the following Table."

- This explains the fact that Viagra was ended up used by a small part of its intended users, and mostly by a larger group who did NOT need it, but were "anxious" about performance. We know that ED (erectile dysfunction) is mostly psychological as the people - when tested - are perfectly capable to have erectiosn during their sleep.

Very recent paper on the topic - only 1/3 of usage is medical, the rest is to PARTY!
[link to ncbi.nlm.nih.gov (secure)]

Extract:
"A total of 65 men participated in the study. Of the total study participants, 33.8% were aged 25–34 years and about 40% of them had multiple sexual partners. The use of sildenafil for recreational purposes was 66.2% and was found to be higher than its use for medical purposes 33.8%."

- And in children?
In children, there are a few reports like these
(see image 3# for full abstract): A 2-year old had painful priapism!
[link to researchgate.net (secure)]
Would be even worse for a 13 years old - with som psychological effets in addition!

4. What to conclude?

- This molecule is mostly a party drug ( I wonder what millennial and younger females would think when hearing that)
- This molecule may improve some pathology even in children, but was given for years in OFF-Label, wit some death costs. (then why this scandal about the SAFER off-label usage of hydroxy-chloroquine?)
- The ideal dosage seems critical - evident in kids!
- It can give an erection to even a 2 years old...
but what if given to young males around puberty? What would the impact be on that population?

Now I will finish with another (funny) info - it seems that the youth using such drugs (Viagra, but also Cialis, and the other one) are becoming psychologically-dependent on this drug - their INITIAL fears becoming even more present if they DO not have the pill before trying to be intimate.

Sounds like Karma?

Last Edited by JADR+ on 07/14/2023 09:20 PM