It was the news that shocked millions of Britons.
Sudafed can be taken off the shelves or even made by prescription because of links to extremely rare but deadly brain diseases.
However, some countries have already taken similar measures to control access to pseudoephedrine, a cold and flu drug.
For example, the drug that causes nasal congestion has been banned from the shelves in the Netherlands for more than 30 years because of heart problems.
And in France, medicines containing the chemical are only available after consulting the pharmacist.
More than 10 countries worldwide already restrict the sale of drugs containing pseudoephedrine. In the Netherlands, drugs containing pseudoephedrine have been banned from the shelves for more than 30 years because of heart problems. The Colombian government, meanwhile, banned the trade in drugs containing the chemical more than a decade ago after it was found to be producing crystal meth
Meanwhile, some countries, including the US, have stricter limits on the amount of pseudoephedrine consumers can buy because it can be so easily converted into meth.
Tablets and capsules used to relieve nasal congestion — including some from Day & Night Nurse and Benadryl — contain pseudoephedrine.
In extremely rare cases, this drug can cause posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS).
Both of these reactions can increase the risk of stroke by putting pressure on blood vessels, reducing blood flow to the brain and causing it to swell.
Although it has been known for decades, regulators are appalled by the “new business.”
Read more: Are these the things that alarmed health chiefs about Sudafed’s safety clearance? Cases of a French girl (18) and a Turkish man (56) affected by an extremely rare but fatal side effect
Chiefs of Britain’s medicines and healthcare products regulator, which oversees drug safety, are “examining the available evidence” to see if sales rules need to be changed.
However, Whitehall sources told MailOnline that such a decision was unlikely.
Michelle Riddalls, chief executive of PAGB – the consumer health organization representing manufacturers of OTC medicines, said: “Warning statements about these concerns are already present in product information in the UK.
“But as befits the MHRA will also undertake an assessment to see if any changes are needed in the UK.”
She added: “If people are concerned about the medicines they are taking, they can speak to a pharmacist.
“Pharmacists are healthcare professionals who can provide advice and support on self-treatable conditions and consumer healthcare products.”
The European Medicines Agency is conducting its own study on the side effects of the medicine.
Officials on the mainland have noted a “small number” of new PRES and RCVS cases in surveillance databases and medical literature.
The review, launched at the request of the French Medicines Agency, will determine whether pseudoephedrine should be “maintained, modified, suspended or withdrawn” across the EU.
In France, access to pseudoephedrine was restricted in 2020 in response to cases of serious side effects, particularly heart attacks and strokes.
Warnings followed in 2008 and again in 2012 from the country’s national pharmacovigilance commission about its cardiovascular side effects.
Recent studies suggest that both RCVS and PRES increase the risk of long-term stroke and therefore the risk of death. PRES is associated with a variety of conditions, but the most common are high blood pressure, eclampsia, serious infections, kidney disease and some autoimmune disorders
Risk factors associated with RCVS include certain prescription medications, such as antidepressants, nasal decongestants, nicotine patches, and head injuries
Drugs containing the chemical are only available to patients after consulting a pharmacist.
But the Netherlands withdrew pseudoephedrine entirely in 1989 over similar concerns.
However, concerns about pseudoephedrine are not just limited to health.
Crystal meth has become more available, more effective and cheaper than ever in recent years.
And as the Netflix hit “Breaking Bad” demonstrated, pseudoephedrine also functions as an “essential” ingredient in the production of the recreational drug.
ALSO READ: Revealed: Deadly Circumstances Behind Sudafed Security Audit That Wiped Millions Of Cold And Flu Prescription Drugs From Shelves
Mexico imposed a ban in 2007 after concerns about its use to make meth.
This means that people in Mexico cannot legally take drugs that contain the chemical.
Colombia followed in 2010 for the same reason.
In the US, efforts to control the sale of drugs containing the chemical date back to 1986 to prevent the illegal manufacture of crystal meth.
How you buy drugs that contain pseudoephedrine varies by state.
Nearly 40 states, including Florida, Ohio and California, have laws requiring pharmacies to sell it “behind the counter.”
But the U.S. Food and Drug Administration also sets nationwide limits on how much pseudoephedrine consumers can buy in a month.
Nationwide, no one can buy more than 3.6g of pseudoephedrine per day, or 9g over a 30-day period.
Daily decongestant tablets found on pharmacy shelves often contain between 30 mg and 60 mg of pseudoephedrine hydrochloride.
For example, in the UK 60mg is contained in Sudafed decongestant tablets or Benadryl Plus capsules which are available over the counter from, for example, Boots or Lloydspharmacy.
The US is not the only one restricting their use.
Pseudoephedrine is already subject to sales restrictions in the UK, although it has been widely used for decades.
Since 2008, it has been illegal to sell or supply any product containing more than 720mg of pseudoephedrine to Britons without a prescription.
Daily decongestant tablets found on pharmacy shelves often contain between 30 mg and 60 mg of pseudoephedrine hydrochloride. For example, in the UK 60mg is contained in Sudafed decongestant tablets or Benadryl Plus capsules which are available over the counter from for example Boots or Lloydspharmacy
It followed a ruling by the Commission for Medicinal Products for Human Use, which claimed it had imposed the restriction “to manage the risk of pseudoephedrine abuse”.
Also in New Zealand, according to the Misuse of Drugs Act 1975, it is only possible to obtain drugs containing pseudoephedrine on prescription.
Similarly, the illegal use of pseudoephedrine in Australia led to all products containing the chemical being labeled as either “Pharmaceutical Drugs” or “Prescription Medicines” in 2006.
Whether it can be sold when a pharmacist is directly involved or whether GP intervention is required depends on the amount of the chemical In treatment.
The county is also encouraging its pharmacists to track purchases of pseudoephedrine-containing products in Project STOP’s online database to prevent people from buying small amounts of the drugs in different pharmacies within a short period of time.
Meanwhile, in Japan, drugs containing more than 10 percent pseudoephedrine are banned under their Stimulant Control Law.
Source link
Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
