The deadly conditions behind Sudafed safety review
The deadly conditions behind Sudafed safety review which could see cold and flu remedies taken by millions pulled from shelves or made prescription-only
- Decongestant pseudoephedrine has been found to trigger PRES and RCVS
- Studies suggest RCVS and PRES both increase the long-term risk of strokes
- Both are usually reversible after prompt diagnosis and treatment of symptoms
- Read more: Brits react to news that decongestants could be pulled from shelves
Health watchdogs are reviewing the safety of some everyday decongestants over potential links to two deadly brain disorders.
Tablets and capsules taken to relieve a blocked nose, including some options made by Sudafed, Nurofen and Day & Night Nurse, contain pseudoephedrine.
In rare cases, this drug can trigger a life-threatening reaction in the brain’s blood vessels called posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS).
The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, has launched a review into a host of over-the-counter medicines that contain the drug.
It comes after bosses at its EU counterpart, the European Medicines Agency (EMA), sparked fears by launching their own review into the safety of the medicines less than a fortnight ago.
But what are the two deadly brain conditions? How can they be treated? And who is most at risk of developing the two deadly conditions?
Here’s everything you need to know.
Medicines containing pseudoephedrine have been discovered in rare cases to trigger posterior reversible encephalopathy syndrome (PRES). Signs often include headaches, vision problems and seizures – found in over two thirds of cases – according to the NHS
Medicines containing pseudoephedrine have been discovered in rare cases to trigger reversible cerebral vasoconstriction syndrome (RCVS). A severe ‘thunderclap’ headache is the hallmark sign of RCVS and it may be the only symptom. But other signs of the condition could also include seizures, vision problems and weakness on one side of the body
What are PRES and RCVS?
The rare conditions both involve reduced blood supply — known medically as ischaemia — to the brain, causing it to swell.
PRES may develop at any age from infants to the elderly, but dozens of studies have found it most frequently affects adults in their 40s and 50s. It is also slightly more common in women.
Likewise, RCVS is also more often diagnosed in women between the ages of 20 and 50.
In younger woman, it can sometimes be associated with the changes that happen after giving birth, during pregnancy or when starting or changing birth control pills.
Read more: ‘What are we supposed to do? Wait two weeks to get a Sudafed prescription?’: Britons react to news that drug could be pulled from UK shelves or made prescription-only because of links to rare brain disorders
PRES predominantly – but not exclusively – affects the back of the brain.
Normally associated with high blood pressure, this excessive pressure causes blood vessels to become permeable allowing the surrounding brain tissue to swell.
RCVS meanwhile occurs when persistent contraction of the blood vessels – vasoconstriction – causes arteries to narrow. This reduces blood flow and oxygen delivery to the affected area of the brain.
How is it triggered?
PRES is associated with numerous conditions, though most frequently with high blood pressure, eclampsia, severe infection, kidney disease, and certain autoimmune diseases.
It is also associated with the use of several medicines, particularly decongestants like Sudafed and Nurofen or immunosuppressants and cancer chemotherapy.
In rarer cases, it could occur as a side effect of the antibiotic linezolid, scorpion poisoning and after LSD and cocaine use.
Risk factors associated with RCVS include certain prescription medications, such as anti-depressants, nasal decongestants, nicotine patches and head injuries.
It could also be triggered by blood and intravenous immunoglobulin transfusions, as well as vasoactive secreting tumours.
What are the tell-tale symptoms?
Signs of PRES often include headaches, vision problems and seizures – found in over two thirds of cases – according to the NHS.
Those suffering from the condition may also experience confusion, weaknesses of one or more limbs, nausea and difficulty when speaking.
The symptoms of PRES usually come on quickly in a matter of hours and worsen over a period of 12 to 48 hours.
A severe ‘thunderclap’ headache is the hallmark sign of RCVS and it may be the only symptom.
But other signs of the condition could also include seizures, vision problems and weakness on one side of the body.
Some also experience difficulty understanding others when they’re speaking and difficulty speaking themselves.
Decongestants including Sudafed and Day & Night Nurse might be pulled from shelves or even made prescription-only because of links to the rare but deadly brain disorders. The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, is behind the review. The health watchdog told MailOnline yesterday that cases have been ‘very rarely reported with these medicines’
Can it kill?
In the vast majority of cases of PRES and RCVS, patients recover from their symptoms.
But in some instances, it can be life-threatening.
Recent studies also suggest that RCVS and PRES both increase the long-term risk of strokes, raising the risk of death.
The mortality rate is thought to sit between three and six per cent of all cases of PRES and under five percent of RCVS cases.
Read more: Sudafed, Nurofen and Day & Night Nurse could be BANNED or become prescription-only as officials launch probe into rare yet deadly brain side effects linked to decongestant taken by millions
Can it be treated?
Diagnosis of both PRES and RCVS is difficult, and clinical judgement is essential.
MRI and CT scans are used to see the area affected by constricted or permeable blood vessels. An angiogram may also be used to view the arteries.
If recognized and treated promptly, the rapid-onset symptoms of PRES usually fully resolve within a week.
Experts often recommend that patient’s blood pressure is reduced by 25 per cent in the first few hours of treatment.
But PRES may recur in around five to ten per cent of cases, more commonly in patients with uncontrolled hypertension.
Treatment of RCVS depends on the severity of the condition.
Supportive care is directed toward managing blood pressure, severe headaches, and other complications such as seizures.
Fluids are also often administered intravenously and migraine treatments such as aspirin or Depakote may also be prescribed.
When should I see a doctor?
Anyone thought to have the symptoms of PRES or RCVS should seek medical help immediately.
Severe forms of the condition will need to be treated in hospital.
Following brain imaging in hospital, sometimes further investigations may need to be performed.
According to the NHS, this includes blood tests and a lumbar puncture to rule out other causes of your symptoms that may cause similar narrowing of the blood vessels.
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