How Sudafed drug behind safety review is controlled across the world

From being BANNED by Dutch health chiefs over heart fears to prescription-only in the US because it’s so easy to turn into meth: How Sudafed drug behind safety review in the UK and Europe is already controlled across the world

  • Decongestant pseudoephedrine has been found to trigger PRES and RCVS 
  • The EMA and MHRA are now undertaking safety reviews of the medicine
  • Over 10 countries already implement restrictions on sale of pseudoephedrine
  • Read more: Are THESE what spooked health chiefs into the safety reviews?

It was the news that shocked millions of Brits.  

Sudafed could be pulled from shelves or even made prescription-only because of links to extremely rare but deadly brain disorders.

But some countries have already taken similar action to control access to cold and flu remedy pseudoephedrine.

For example, the drug — which unblocks noses — has been banned from shelves in the Netherlands for over 30 years over heart concerns. 

And in France, drugs containing the chemical are only available after a pharmacist consultation. 

More than 10 countries worldwide already implement restrictions on sale of pseudoephedrine-containing medicines. in the Netherlands, drugs containing pseudoephedrine have already been banned from shelves for over 30 years, over heart concerns. The Colombian government meanwhile, prohibited the trade of medicines containing the chemical more than a decade ago after it was found to make crystal meth

Meanwhile, some countries — including the US — have tougher limits on how much pseudoephedrine consumers can purchase because of how easily it can be turned into meth.  

Tablets and capsules taken to relieve a blocked nose — including some made by Day & Night Nurse and Benadryl — contain pseudoephedrine.

In exceptionally rare cases, this drug can trigger posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS).

These reactions can both increase the risk of strokes, by putting pressure on blood vessels, reducing blood supply to the brain, causing it to swell. 

Although known about for decades, regulators are spooked by the ‘new cases’.  

Read more: Are THESE what spooked health chiefs into safety review of Sudafed? Cases of French girl, 18, and Turkish man, 56, struck down with extremely rare yet deadly side effect

Bosses at the UK’s Medicines and Healthcare products Regulatory Agency, which polices the safety of drugs, is ‘reviewing available evidence’ to see if the sale rules need to change. 

Whitehall sources told MailOnline, however, that such a decision was unlikely.

Michelle Riddalls, chief executive of PAGB — the consumer healthcare association, which represents manufacturers of OTC medicines, said: ‘Warnings related to these concerns are already present on the product information in the UK. 

‘However as is right, MHRA will also being making an assessment to see if any changes are needed in the UK.’

She added: ‘If people have any concerns about the medicines they are taking, they can speak to a pharmacist. 

‘Pharmacists are expert healthcare professionals who can provide advice and support on self-treatable conditions and consumer healthcare products.’ 

The European Medicines Agency is carrying out its own probe into the medicine’s side effects.

Officials on the continent had noted a ‘small number’ of new PRES and RCVS cases in surveillance databases and medical literature.

Initiated at the request of the French medicines agency, the review will determine whether pseudoephedrine should ‘be maintained, varied, suspended or withdrawn across the EU’. 

In France, access to pseudoephedrine was tightened back in 2020 in response to cases of serious adverse events – in particular heart attacks and strokes. 

It followed warnings in 2008 and again in 2012 by the country’s own National Pharmacovigilance Commission about the cardiovascular side effects.

Recent studies suggest that RCVS and PRES both increase the long-term risk of strokes, raising the risk of death. PRES is linked with a swathe of conditions, though most frequently with high blood pressure, eclampsia, severe infection, kidney disease and some autoimmune diseases

Risk factors associated with RCVS include certain prescription medications, such as anti-depressants, nasal decongestants, nicotine patches and head injuries

Drugs containing the chemical are now only available to patients after a consultation with a pharmacist.  

But the Netherlands withdrew pseudoephedrine completely in 1989 over similar fears.   

Concerns over pseudoephedrine are not just limited to health, however.  

Crystal meth in recent years has become more available, potent, and cheaper than ever before.

And as Netflix hit Breaking Bad illustrated, pseudoephedrine also works as an ‘essential’ ingredient in making the recreational drug.  

Read more: Revealed: Deadly conditions behind Sudafed safety review which could see cold and flu remedies taken by millions pulled from shelves or made prescription-only

Mexico enforced a ban in 2007 after concerns over its use in making meth. 

It means people in Mexico cannot legally use medicines containing the chemical. 

Colombia followed for the same reason in 2010.  

In the US, attempts to control the sale of medicines with the chemical date back to 1986, to prevent illegal manufacture of crystal meth. 

How you purchase medications containing pseudoephedrine varies state by state. 

In nearly 40 states, including Florida, Ohio and California, there are laws requiring pharmacies to sell it ‘behind the counter’.

But the US Food and Drug Administration also sets limits nationwide on how much pseudoephedrine consumers can purchase over a month-long period.

Across the country, no-one can purchase more than 3.6g of pseudoephedrine a day or 9g over a 30 day period. 

Everyday decongestant tablets found on pharmacy shelves often contain between 30mg and 60mg of pseudoephedrine hydrochloride. 

In the UK for instance, 60mg can be found in Sudafed decongestant tablets or Benadryl Plus Capsules, for example, available over the counter in Boots or Lloydspharmacy.

The US isn’t alone in restricting its use. 

Sales restrictions are already placed on pseudoephedrine in the UK, despite it being widely available for decades. 

It has been illegal to sell or supply any product to Brits which contains more than 720mg of pseudoephedrine without a prescription since 2008. 

Everyday decongestant tablets found on pharmacy shelves often contain between 30mg and 60mg of pseudoephedrine hydrochloride. In the UK for instance, 60mg can be found in Sudafed decongestant tablets or Benadryl Plus Capsules, for example, available over the counter in Boots or Lloydspharmacy

It followed a ruling from the Commission on Human Medicines, which claimed it implemented the restriction ‘to manage the risk of misuse of pseudoephedrine’. 

Under the Misuse of Drugs Act 1975, in New Zealand it is also only possible to get medications containing pseudoephedrine on prescription. 

First classified in 2004, over fears it was the ‘essential’ component to crystal meth, it was only in 2009 that then Prime Minister John Key revealed pseudoephedrine-based cold and flu tablets would become prescription-only, becoming law in 2011.  

Likewise, in Australia, illicit use of pseudoephedrine saw all products containing the chemical labelled either ‘pharmacist only medicines’ or ‘prescription only medicines’ in 2006. 

Whether they can be sold when a pharmacist is directly involved or require GP intervention depends on the amount of the chemical in the medicine. 

The nation also encourages its pharmacists to log purchases of pseudoephedrine containing products on the online database Project STOP, helping to prevent people buying small amounts of the medicines from different pharmacies in a short space of time. 

Meanwhile in Japan, medications that contain more than 10 per cent pseudoephedrine are prohibited under their Stimulants Control Law.

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