Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, May 14, 2015

GSK Given Warning Over Baby and Infant Medicine







It's only being reported in one news media outlet and I have wrote to them to ask for confirmation but, it seems like, GSK have been given a warning by the UAE ministry regarding the dosage instructions for Panadol.

The National UAE write the following...

The Ministry of Health has issued a warning to pharmaceuticals company GlaxoSmithKline telling it to modify the dosage instructions on the packaging of Panadol Baby and Infant Suspension. 
The ministry said that it discovered a mistake in the prescribed dosage that could lead to overdose, which could cause liver poisoning in children. 
Paediatricians, pharmacists and medical practitioners have been told to calculate the adequate dose based on the child’s age and weight and not rely on the dosage instructions shown on the outer package of the medicine until they are duly modified and approved by the drug department at the ministry.

It's a surprisingly short article given that parents may be administering potentially lethal doses of Panadol to their infants and children without actually realizing it!

The Ministry of Health UAE make no mention of the above on their website so I flicked GlaxoSmithKline an email to ask for confirmation of the alleged warning they had received.

Dear GSK,
I am writing to you in regard of a recent article that appeared in The National UAE that made reference to your product Panadol.
The article suggests that GSK were issued a warning by the UAE Ministry because, and I quote,  "they discovered a mistake in the prescribed dosage that could lead to overdose which could cause liver poisoning in children."
 Can you confirm if, in the interests of transparency, this article is correct please.
Sincerely,
--
Bob Fiddaman

Given that GSK normally make you jump through hoops before they answer a straight forward question, I've decided to run with this article and also highlight where Panadol has been in the news before.

In 2013 the Essential Baby online magazine wrote an article regarding a safety scare over GSK's Panadol. At the time, GSK acted promptly. They had learned that Children's Panadol Baby Drops syringes were faulty and could lead to parents giving their children more medication than is required.

Here's a photo of the faulty syringe compared to the correct syringe.


I'm sure you'll agree that's quite a faulty product. GSK's Children's Panadol Baby Drops  is for babies and children aged between one month and two years of age.

At the time GlaxoSmithKline medical director Andrew Yeates said even if babies had been given the incorrect doses of medication using the syringes, there was a "low risk" to their health.

Hmm, thanks for the reassurance!

One year later and the Essential Baby online magazine were once again reporting on GSK's Panadol.

This time they learned that GSK's Children's Panadol 1-5 Years Colour free Suspension also had a faulty syringe. Here's what they wrote...

The confusion with the Panadol syringe stems from the fact that to measure a correct dose, the widest part of the plunger needs to be in line with the desired dosage marking on the syringe.
"This differs from most syringes which measure to the tip of the plunger where the liquid finishes," the advisory reads. 
"With the Children's Panadol syringe, the liquid continues past the tip of the plunger and therefore needs be measured to where the widest sides of the plunger meet the barrel of the syringe."
If the syringe is used to measure in the incorrect way, an extra 1.26mls will be given with each dose of Children's Panadol.
Excessive doses of paracetamol can be harmful to the liver and the harmful effects can be fatal if not detected and treated.

So, if the story currently being covered by The National UAE is, in fact, correct then one has to ask, why can't GSK get their dosages right, more importantly, isn't it about time that they did? The target population for these products, infants and babies, really can't do it for themselves!

When we also take into account that GSK have been accused of making payments of $1,500 each to two doctors to promote Panadol in Syria then alarm bells must surely be calling for Andrew Witty to get his house in order.

This company, it could be argued, could damage your child's health.


Bob Fiddaman.

**If I get a response from either GSK or The National UAE then I shall amend this blog post accordingly.**






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