A young girl was left in intensive care after taking cold and flu medicine, currently undergoing security clearance.
The 18-year-old from France was left confused, vomiting and struggling with blurred vision and headaches after taking pseudoephedrine.
She spent six days in intensive care after one of the extremely rare but deadly complications that has alarmed health chiefs across Europe.
Her case – and another similar case involving a Turkish man in his 50s – is expected to be reviewed by regulators assessing the health risks of pseudoephedrine.
The British medical regulator has launched a safety investigation into the drug, it was announced yesterday.
An 18-year-old from France became confused, vomited and struggled with blurred vision and headaches after taking pseudoephedrine. Her case – and another similar case involving a Turkish man in his 50s – is expected to be reviewed by regulators assessing the health risks of pseudoephedrine. The MHRA is “assessing available evidence” to determine whether rules on the sale of products such as Sudafed and Day & Night Nurse need to change
The Medicines and Healthcare products Regulatory Agency (MHRA) is “reviewing available evidence” to determine whether the rules governing the sale of products such as Sudafed and Day & Night Nurse should be changed.
New posts from two life-threatening complications, one of which can cause a stroke.
The conditions, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), occur when blood flow to the brain is reduced and it swells.
Pseudoephedrine may be pulled from the shelves or only available on prescription if MHRA officials decide that action is necessary.
However, Whitehall sources told MailOnline a rule change was unlikely.
ALSO READ: Revealed: Deadly Circumstances Behind Sudafed Security Audit That Wiped Millions Of Cold And Flu Prescription Drugs From Shelves
Other decongestants such as B. Benylin and Sinutab products will also be affected if a change is required.
Dozens of own-brand products – including those from Boots and Lloyds – also contain the chemical.
It comes after bosses at the European Medicines Agency (EMA) launched their own investigation into the drug’s safety less than two weeks ago.
It found that a “small number” of cases had been recorded in surveillance databases and medical literature.
One such case is probably that of the French girl who has not been identified.
Doctors at Amiens University Hospital reported the case of PRES in March 2022 in the journal Frontiers of Medicine.
The 18-year-old, who has kidney failure, was already undergoing hemodialysis – a treatment with a machine to filter waste and water from the blood – three times a week.
She also suffered from a bacterial infection in her bloodstream caused by a catheter.
The unidentified woman, who was admitted to the emergency room with mental confusion, blurred vision, headache and vomiting, had taken an oral decongestant containing 60 mg of pseudoephedrine earlier in the day.
Daily decongestant tablets found on pharmacy shelves often contain between 30 mg and 60 mg of pseudoephedrine hydrochloride.
About 60 mg is contained in Sudafed decongestant tablets or Benadryl Plus capsules, which are available over the counter in Boots or Lloydspharmacy, for example.
Signs of PRES are common headaches, vision problems and seizures – which occur in more than two-thirds of cases, according to the NHS. Symptoms of PRES usually appear quickly, within hours, and worsen over a period of 12 to 48 hours
While the woman’s blood and blood sugar levels were classified as normal, the doctors diagnosed high blood pressure of 210/100 mmHg.
The ideal blood pressure is between 90/60 mmHg and 120/80 mmHg.
She was transferred to the intensive care unit, where she was sedated and ventilated.
MRI brain scan results later showed swelling of her blood vessels and brain tissue, causing the blood-brain barrier to break down.
The woman – who made a full recovery – also had kidney failure and sepsis, tests revealed.
Doctors wrote, “Uncontrolled high blood pressure from oral decongestants in renal failure and sepsis can cause PRES.”
Read more: What should we do? Waiting two weeks to get a Sudafed prescription?
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.
Doctors are not quite sure what is behind PRES. But seven out of ten patients have high blood pressure, which puts pressure on blood vessels and causes surrounding brain tissue to swell.
Signs of PRES are common headaches, vision problems and seizures – which occur in more than two-thirds of cases, according to the NHS.
Symptoms of PRES usually appear quickly, within hours, and worsen over a period of 12 to 48 hours.
Later in September 2022, medics at Konya City Hospital in Turkey also noted a new case of PRES in a 56-year-old man.
To relieve his runny nose, sore throat and headache, the unidentified man took two doses of paracetamol and pseudoephedrine tablets.
But after his second dose, he had a generalized tonic-clonic seizure while sleeping—during which muscles would stiffen, the patient would lose consciousness, and arms and legs would rapidly twitch.
Doctors wrote in the journal Clinical Neuropharmacology that it was the man who are not known to have risk factors associated with the potentially fatal condition.
However, an MRI scan showed swelling on both sides of the brain, leading doctors to diagnose PRES.
The man was later diagnosed with high blood pressure and diabetes at a follow-up appointment.
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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.
