Documented evidence of sedative effects of Calpol.

Thought this might be useful to have a thread where these could be posted.

It's going to be a very, very short thread.
I can't understand where the Foundation are going on this.

CHEMICALS IN CALPOL :

Each 5ml contains 120mg of paracetamol P Eur
Sucrose (sugar )
Glycerol
Sorbitol
Methyl hydroxybenozate
Xanthan gum
srawberry flavouring
carmoisine ( E122)

Terence Stephenson, professor of child health at Nottingham University, believes their use by parents may be misguided.

"Paracetamol doesn't have any sedative properties whatsoever and neither does Nurofen," he says. "It's a widespread misconception that Calpol helps children to sleep. Doctors used to prescribe antihistamines to help children sleep, but not any longer."

"I've never seen an overdose of Calpol," says Dr Wayne Lenney, a consultant paediatrician. "The only liquid overdoses in children occur when teenagers drink too much alcohol."

Doctors agree that as painkillers these medications are effective and, most importantly, safe. "There was a study in the US of over 80,000 children given ibuprofen and paracetamol, and the number of those who developed side effects that could be attributed to the medicine was absolutely tiny," says Prof Stephenson.

I dont believe calpol had anything to do with this case

We agree on that Woodward.

As I haven't read all of Amaral's book, please could someone explain why he thought they were 'drugged' with calpol? Is there anything in the files about calpol being used?

As far as I am aware Autumn, all that was mentioned was that they had calpol. it certainly wasnt the calpol night as it wasnt released to the market till Dec 2009.

From memory it was first mentioned in the Portuguese press so was leaked and then Amaral mentioned it in an interview.

Have to say, bunny, the calpol thing is a sticking point for me. I don't think calpol had anything to do with what happened either.

Calpol is mentioned in his book Autumn.
I'll see if I can find a link.

Chapter 4 I think it is.

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Autumn wrote:Have to say, bunny, the calpol thing is a sticking point for me. I don't think calpol had anything to do with what happened either.

I agree. Its one of the worst myths around. I found it shocking hearing Amaral say it was used as a sedative. I just cant believe he could be that stupid! so who fed him this rubbish about calpol having sedative effects?

Dont laugh but......I saw it on 3as before Amaral discussed it or it was ever mentioned. I cant see Amaral being that stupid though to read and believe stuff from 3as.

So why? why did he get this so terribly wrong? It makes me wonder if someone is setting him up if Im honest.

Thanks, Inyx :flower:

Yes, I recall some discussion about it on 3As but have always been doubtful about why it was thougt to be relevant to the case. I wondered if something had got confused in translation as it is not a sedative.

I think someone, who is seen as a Anti should explain to Mr Bennett about Calpol. He seems convinced the McCanns used it.

Autumns, what's been amazing me is that Amaral (who should know better) is speculating about Calpol as a sedative.

And now the MF also seems to raise the issue. Or did I get that wrong?

I do not recall reading anywhere in the PJ files about the finding o Calpol, i do remember Amaral making mention to a Calpol like subtance. Calpol like substance - Medised

Two active ingredients, paracetamol and diphenhydramine hydrochloride.

We all know how paracetamol works - diphenhydramine is a sedating antihistamine, first generation. Interestingly, an advisory warning was applied to medised in early 2009.


[/quote] Medised is no longer recommended for children under six years of age. This is because there is no evidence that they work in this age group, and they can potentially cause side effects such as allergic reactions, effects on sleep or hallucinations [quote]

Note additional side effects - Given at recommended dosage side effects include profound drowsiness (very common), along with the possibilities of motor impairment (ataxia) and rapid or irregular heartbeat (tachycardia).

Whereas, considerable over dosage can lead to myocardial infarction (heart attack), serious ventricular dysrhythmias, coma and death.

Cue colomba connection perhaps...

kangdang wrote:I do not recall reading anywhere in the PJ files about the finding o Calpol, i do remember Amaral making mention to a Calpol like subtance. Calpol like substance - Medised

Two active ingredients, paracetamol and diphenhydramine hydrochloride.

We all know how paracetamol works - diphenhydramine is a sedating antihistamine, first generation. Interestingly, an advisory warning was applied to medised in early 2009.

Medised is no longer recommended for children under six years of age. This is because there is no evidence that they work in this age group, and they can potentially cause side effects such as allergic reactions, effects on sleep or hallucinations

Note additional side effects - Given at recommended dosage side effects include profound drowsiness (very common), along with the possibilities of motor impairment (ataxia) and rapid or irregular heartbeat (tachycardia).

Whereas, considerable over dosage can lead to myocardial infarction (heart attack), serious ventricular dysrhythmias, coma and death.

Cue colomba connection perhaps...

Not worth really arguing. Check the ingredients between Calpol and Calpol nyte, then come back with the same conclusion, you won't be able to.

diphenhydramine hydrochloride is contained in |Calpol Nyte which was not released until Madeleine had gone missing.

whoknowsthetruth wrote:I think someone, who is seen as an 'anti', should explain to Mr Bennett about Calpol. He seems convinced the McCanns used it.

Well, let us start with what I think are four unassailable facts:

1. Dr Kate McCann's father Brian Healy said that the McCanns did use Calpol.

2. Calpol was found amongst the McCanns' luggage.

3. Madeleine was three years old at the time she was reported missing.

4. The twins were two at the time.

I do not say that Calpol is relevant to what really happened to Madeleine although I would also put on record that neither do I rule it out.

Against that background, here is a recent Ecologist article on Calpol which on this occasion I will reproduce in full and will bold the most important bits:

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Behind the Label: Calpol

Pat Thomas

29th October 2009

The season of flu (and fear of swine flu) is upon us. But before you reach for this sticky pink cocktail dished out by doctors and parents as a cure-all for children, think again...

Practically speaking, swine flu is not all that different from seasonal flu in symptoms and treatment. And children aren't at any particularly increased risk, above that they face from normal flu, but somehow the word 'swine' before flu has got parents in a panic - fuelled by the media - and feeling more helpless than ever.

Enter Calpol, uncritically accepted by parents - and bizarrely by doctors too - as a kind of sticky pink magic bullet for whatever ails your child. As far as we at the Ecologist know, Calpol is not a cure for swine flu but you wouldn't know if from the conversations floating around on parental e-forums:

‘Not much we can do, except keep shovelling in Calpol and keep an eye on them'.

‘I called the doctors and was told to give him Calpol and call back in the morning'.

‘They told us there [at the A&E] to carry on with Calpol, it most likely is swine flu and that we can put the Tamiflu in her strawberry milk'.

No wonder profits are soaring.

In the UK the whole of the children's medicine category is currently worth £137 million a year and is predicted to grow by more than £20 million in the next five years. This growth is apparently due to a greater emphasis on parents self-selecting over the counter (OTC) medicines to treat children's minor ailments.

The sickness business

Calpol, the number one selling children's medicine, has a commanding 70 per cent share of the 'pain and fever' sub-market, which accounts for around half of the total children's medicine market.

This lofty position, according to former manufacturers Pfizer (the medicine is now marketed by McNeil Healthcare UK), is testament to Calpol's 'heritage and commitment to meeting the changing needs of twenty-first century parents'.

Or maybe it is just a testament to parent's general feelings of fear and vulnerability when their kids get sick.

The Calpol range has grown considerably in recent years to include not just the original infant suspension (which contains paracetamol as its active ingredient and is now also available as handy Calpol Infant Suspension Sachets). It now includes Calprofen (with ibuprofen as its active ingredient) as well as Calpol Six Plus Fastmelts (melt in the mouth paracetamol for the over 6s) as well as Calcold (contains paracetamol and diphenhydramine), Calcough Chesty (contains guaifenesin) and Calpol Night (contains paracetamol and diphenhydramine).

Worrying research

So, there's something for everybody. And if it brings down fever and gives parents a better night's sleep what's the harm?

Well, late in 2008 a paper published in the respected medical journal The Lancet challenged many parent's perceptions of the harmlessness of Calpol. Researchers who analysed data on more than 200,000 children found strong links between their exposure to paracetamol as infants and the development of asthma, eczema and other allergies at age 6-7.

In fact using the drug in the first year of life increased the risk of hay fever and eczema at the age of 6 and 7 by 48 per cent and 35 per cent respectively.

The more paracetamol a child had in the early years of life, the higher the risk. Thus children under 12 months who were given a paracetamol-based medicine at least once a month more than tripled the chances of suffering wheezing attacks by the age of 6 or 7. The researchers noted that increased use of paracetamol - because of earlier fears about giving children aspirin - could be a factor in worrying rise in rates of asthma in many countries.

Fever phobia

The problem is that because it is so widely available, and recommended by everyone for everything, we don't tend to think of Calpol as medicine. Parents are not encouraged to be thoughtful or frugal in their use of Calpol.

Nor are they encouraged to understand the basic mechanisms of illness with which medicines like paracetamol interfere. In particular parents' fever phobia is something that urgently needs to be addressed

Many doctors will tell you that at least 95 per cent of childhood illnesses are self limiting. In other words they will heal by themselves and do not require any medical intervention. Of course prevention is an important part of health care, but just-in-case medicine, given without any clinical basis, can make symptoms worse and produce a whole range of new and even more debilitating side effects.

Good examples of this idea abound in our approach to common experiences such as fever, earache and coughs.

Fever often develops during an infection. Although we generally think of fever as a bad thing, fever enhances the inflammatory response of the body, and certain components of the immune system work optimally at increased body temperature. Also fever helps to limit the growth of some germs that cannot grow well at higher temperatures.

Suppressing fever with medicines like Calpol interferes with this essential mechanism.

For children, fever can serve another important function. Our children are not born with mature immune systems and fever is one way of activating and 'educating' the immune system to respond when needed. Because of this, temperatures up to 39 C (102 F) don't usually provide sufficient grounds for action unless your child is prone to convulsions.

There is even research to show that warm sponging can be just as effective at reducing skin temperature as paracetamol.

Other ingredients

Calpol of course doesn't just contain paracetamol. It is a veritable cocktail of sweeteners, flavourings, preservatives and colourants to make the product appealing and palatable to infants. These additives include strawberry 'flavouring' and carmoisine (E122- suspected carcinogen, banned in Austria, Japan, Norway, Sweden and the US) to produce its pink colour.

It also contains, Maltitol (a mild laxative), glycerol (E422 - large quantities can cause headaches, thirst and nausea), sorbitol (E420 - large quantities can cause stomach upset), the paraben preservatives methyl parahydroxybenzoate (E218 - suspected hormone disrupter and allergen), propyl parahydroxybenzoate (E216 - suspected hormone disrupter and allergen), ethyl parahydroxybenzoate (E214 - suspected hormone disrupter, banned in France and Australia), and a thickener xanthan gum (E415 - no known adverse effects).

Being such an interesting E-cocktail, it's not surprising that it can cause allergic reactions (such as skin rashes and hayfever-like symptoms), tiredness, unexpected bleeding or tendency towards bruising as well as headache, nausea.

Using paracetamol to treat fever may also result in your child having a seemingly endless round of colds, since the body's natural fever reaction was not allowed to kill the virus causing the illness leaving your child to be reinfected again and again.

E122 and E218 can lead to hyperactivity, and the Hyperactive Children's Support Group identifies them as likely causes of mysterious and sudden cases of ADHD-like hyper-activity.

Is neurofen better?

So is Calprofen, the childrens' neurofen suspension, a better option? Not really. The manufacturers of Nurofen, the UK's best selling adult ibuprofen, list the following adverse effects in their packaging:

Stomach discomfort or pain, nausea, stomach ulcer with or without bleeding, black tarry stools, worsening of asthma, unexplained wheezing or shortness of breath, liver and kidney problems, headache, dizziness, hearing disturbance and rarely skin rash, itching, peeling, easy bruising and facial swelling.

Putting it in a lower dose in a sweet syrup, with a reassuring picture of a happy baby on the packaging, may not be enough to protect your child from such effects. In fact in the US concern was heightened in 2003 when an 11 year old girl developed Stevens Johnson Syndrome - a devastating inflammatory disease that can result in serious gastrointestinal problems, blindness and death - soon after being given a children's ibuprofen for a mild fever.

In 2008 a jury decided, bizarrely, that although manufacturers Johnson & Johnson failed to adequately warn of risks of contracting Stevens-Johnson syndrome on the label, this lack of adequate warning did not make the manufacturers liable for the girl's blindness.

Nevertheless the Stevens Johnson syndrome foundation still insists that the number of reported cases of ibuprofen-related SJS has risen in recent years.

Watch and wait

The medical model of care is action oriented. It pursues germs and suppresses symptoms with single-minded determination. When learning how to take care of their children, parents are encouraged to take this model on board.

The idea of 'watch and wait' caring is still not widely encouraged. Not surprisingly, when faced with the combination of medical opposition to a watch and wait approach and the blind panic whipped up by the media about things like swine flu, many parents end up toeing the line. Calpol is dispensed and all is right with the world - until of course it isn't.

To be health conscious is to understand that there is always 'something going around' which is 'probably a virus'. There are viruses and bacteria in us and around us all the time.

The virus that causes flu or measles may be inside you or your children right now. But you are not ill because your immune system is working efficiently. What makes your child susceptible to these things - allergies, run-down immune system, diet, sleep, emotional distress - is the real question and all play a part in susceptibility to infection and in the course of healing.

Addressing these things first, before you reach for the Calpol, is the most important part of prevention and combined with cuddles, kisses and patience is probably the best way to ensure the speedy recovery of a child with a cold.

[Pat Thomas is a former editor of the Ecologist]

That is a very interesting article, thanks Tony.
Just wondering - do you have a link please, as I would like to post it on a health forum I contribute to.

Ruby wrote:That is a very interesting article, thanks Tony. Just wondering - do you have a link please, as I would like to post it on a health forum I contribute to.

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The manufactrurers' warnings about Calpol Night are at:

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Here are some extracts:

Children under 6 years: Calpol Night is contraindicated in children under the age of 6 years (see section 4.3).

Not to be used for more than 3 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
Do not exceed the stated dose.

Keep out of the reach and sight of children.

Contraindications

Hypersensitivity to paracetamol, diphenhydramine hydrochloride or any of the other constituents.

Large doses of anti-histamines may precipitate seizures in epileptics.

Calpol Night should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOIs) or those patients who have received treatment with MAOIs within the last two weeks (see section 4.5).

Special warnings and precautions for use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease. Patients with hepatic or moderate to severe renal dysfunction or urinary retention should exercise caution when using this product.

Diphenhydramine should not be taken by patients with susceptibility to angle-closure glaucoma or symptomatic prostatic hypertrophy unless directed by a doctor.

Alcohol or other potential sedating medicines should not be used concurrently with Calpol Night.

This product contains propylene glycol and may cause alcohol-like symptoms. Children should be supervised while on this medication.

This product may cause drowsiness. This product should not be used to sedate a child.

Warnings to appear on labelling:

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Do not take with any other cough and cold medicine.

Dose should not be repeated more frequently than four hour intervals.

Not more than 3 doses should be taken in 24 hours.

Special label warnings

Do not give with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if the child seems well.

Do not use to sedate a child.

Special leaflet warnings

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicinal product.

Interaction with other medicinal products and other forms of interaction

The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

CNS Depressants: Diphenhydramine may potentiate the sedative effects of CNS depressants, including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.

Antimuscarinic Drugs: may have an additive muscarinic action with other drugs such as atropine and some antidepressants.

MAOI's: Not to be used in patients taking MAOI's or within 14 days of stopping treatment as there is a risk of serotonin syndrome.

Pregnancy and lactation

Safety in pregnancy has not been established. Pregnant or lactating patients should not take this medication unless it is considered essential by a doctor.

Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.

Diphenhydramine hydrochloride crosses the placenta and is excreted in breast milk.

Effects on ability to drive and use machines

May cause drowsiness, dizziness or blurred vision. If affected do not drive or operate machinery. Avoid alcoholic drink.

Undesirable effects

Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdosage with the drug.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

Adverse effects for diphenhydramine include:

Common side effects

• CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headache, psychomotor impairment

• Antimuscarinic effects: Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions

Rare side effects:

Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions, blood disorders and liver dysfunction.

Hypersensitivity reactions to diphenhydramine have been reported, in particular, skin rashes, erythema, urticaria and angiodema.

Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

a) is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b) regularly consumes ethanol in excess of recommended amounts.

Or

c) is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Symptoms of diphenhydramine overdose include drowsiness, hyperpyrexia and anticholinergic effects. In children, CNS excitation, including hallucinations and convulsions may appear; with larger doses, coma or cardiovascular collapse may follow.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the National Poisons Information Service (NPIS) or a liver unit.

REST SNIPPED

whoknowsthetruth wrote:

kangdang wrote:I do not recall reading anywhere in the PJ files about the finding o Calpol, i do remember Amaral making mention to a Calpol like subtance. Calpol like substance - Medised

Two active ingredients, paracetamol and diphenhydramine hydrochloride.

We all know how paracetamol works - diphenhydramine is a sedating antihistamine, first generation. Interestingly, an advisory warning was applied to medised in early 2009.

Medised is no longer recommended for children under six years of age. This is because there is no evidence that they work in this age group, and they can potentially cause side effects such as allergic reactions, effects on sleep or hallucinations

Note additional side effects - Given at recommended dosage side effects include profound drowsiness (very common), along with the possibilities of motor impairment (ataxia) and rapid or irregular heartbeat (tachycardia).

Whereas, considerable over dosage can lead to myocardial infarction (heart attack), serious ventricular dysrhythmias, coma and death.

Cue colomba connection perhaps...

Not worth really arguing. Check the ingredients between Calpol and Calpol nyte, then come back with the same conclusion, you won't be able to.

diphenhydramine hydrochloride is contained in |Calpol Nyte which was not released until Madeleine had gone missing.

Who is arguing?? I am simply stating what i know. Medised has been on the market for a considerable length of time, long before May 2003.

On the general subject of what was happening in Praia da Luz, is it not true that several of the 'Tapas' children were ill in one way or another that week?

Wilkins' and O'Donnell's baby apparently was crying and Wilkins had to take her out for an hour-long walk on 3 May...hmmm.

Is it out of the question that this holiday was paid for by a medical company which was trialling a sedative for children?

Tony, might I suggest you find out the quality of the food served in the Millenium restaraunt. I think you may find the answer lies there.

bunny wrote:Tony, might I suggest you find out the quality of the food served in the Millenium restaurunt. I think you may find the answer lies there.

Defamation.

Google it Tony.

Tony Bennett wrote:On the general subject of what was happening in Praia da Luz, is it not true that several of the 'Tapas' children were ill in one way or another that week?

And so were some of the adults.
The food at the Millennium Restaurant seems to be a good guess.

Tony Bennett wrote:On the general subject of what was happening in Praia da Luz, is it not true that several of the 'Tapas' children were ill in one way or another that week?

Wilkins' and O'Donnell's baby apparently was crying and Wilkins had to take her out for an hour-long walk on 3 May...hmmm.

Is it out of the question that this holiday was paid for by a medical company which was trialling a sedative for children?

Anything's possible, but I still can't see how the tragic accidental death of a small child could result in the parents doing this afterwards:

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So were other adults as well. Just read some of the reviews.