Health watchdogs are reviewing the safety of some everyday decongestants for possible links to two deadly brain disorders.
Tablets and capsules taken to relieve nasal congestion, 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 blood vessels of the brain called posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS).
The Medicines and Healthcare Products Regulatory Agency (MHRA), which oversees the safety of medicines used in Britain, has launched a review of a number of over-the-counter medicines containing the drug. .
It comes after the heads of its EU counterpart, the European Medicines Agency (EMA), raised fears by launching its own review on drug safety 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 them?
Here is everything you need to know.
In rare cases, medications containing pseudoephedrine have been found to trigger Posterior Reversible Encephalopathy Syndrome (PRES). Signs often include headaches, vision problems and seizures, which are found in more than two-thirds of cases, according to the NHS.
In rare cases, medications containing pseudoephedrine have been found to trigger reversible cerebral vasoconstriction syndrome (RCVS). A strong thunderclap headache is the hallmark of RCVS and 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?
Both rare conditions involve reduced blood supply, known medically as ischemia, to the brain, causing it to swell.
PRES can develop at any age, from infants to the elderly, but dozens of studies have found that it most often affects adults in their 40s and 50s. It is also slightly more common in women.
RCVS is most often diagnosed in women between the ages of 20 and 50.
In younger women, it can sometimes be associated with changes that occur after childbirth, during pregnancy, or when starting or changing birth control pills.
PRES predominantly, but not exclusively, affects the posterior part of the brain.
Doctors don’t know exactly what’s behind PRES. But seven out of 10 patients have high blood pressure, which puts pressure on blood vessels and can cause surrounding brain tissue to swell.
Meanwhile, RCVS occurs when persistent contraction of the blood vessels (vasoconstriction) causes the arteries to narrow. This reduces blood flow and oxygen supply to the affected area of the brain.
How is it triggered?
PRES is linked to a number of conditions, though most often high blood pressure, eclampsia, severe infection, kidney disease, and some autoimmune diseases.
Certain medications, particularly decongestants such as Sudafed and Nurofen, or immunosuppressants and cancer chemotherapy, are also thought to increase the risk.
In rarer cases, it could occur as a side effect of the antibiotic linezolid, scorpion poisoning, or after the use of LSD and cocaine.
Risk factors associated with RCVS include certain prescription drugs, such as antidepressants, nasal decongestants, nicotine patches and head injuries.
It can also be triggered by blood transfusions and intravenous immunoglobulins, as well as by vasoactive-secreting tumors.
UK and EU health watchdogs are investigating the possible decongestant connection after reports of PRES and RCVS among people taking drugs containing pseudoephedrine.
What are the telltale symptoms?
Signs of PRES often include headaches, vision problems and seizures, which are found in more than two-thirds of cases, according to the NHS.
Those with the condition may also experience confusion, weakness in one or more limbs, nausea, and slurred speech.
PRES symptoms usually come on quickly, within hours, and worsen over a period of 12 to 48 hours.
A strong thunderclap headache is the hallmark of RCVS and may be the only symptom.
But other signs can include seizures, vision problems, and weakness on one side of the body.
Some also experience difficulty understanding others when they speak and difficulty speaking themselves.
Decongestants, including Sudafed and Day & Night Nurse, could be pulled from shelves or even sold on prescription due to links to rare but deadly brain disorders. The Medicines and Healthcare Products Regulatory Agency (MHRA), which oversees the safety of medicines used in Britain, is behind the review. The health watchdog told MailOnline yesterday that cases have been “reported very rarely with these drugs”.
Can kill?
In the vast majority of cases of PRES and RCVS, patients recover from their symptoms.
But in some cases, it can be life-threatening.
Recent studies also suggest that RCVS and PRES increase the long-term risk of stroke, thereby increasing the risk of death.
The mortality rate is believed to be between three and six percent of all PRES cases and less than five percent of RCVS cases.
Can it be treated?
The diagnosis of PRES and RCVS is difficult.
An MRI, CT scan, and angiogram (an X-ray of the blood vessels) may be needed.
But if recognized and treated promptly, PRES usually resolves completely within a week.
Experts often recommend that a patient’s blood pressure be lowered by 25 percent in the first few hours of treatment.
But PRES can come back in about five to ten percent of cases, most commonly in patients with uncontrolled hypertension.
The treatment of RCVS depends on the severity of the condition.
But it usually involves controlling blood pressure, severe headaches, and other complications, such as seizures.
Fluids are also often given through an IV drip and migraine treatments such as aspirin may also be prescribed.
When should I see a doctor?
Anyone who thinks they have the symptoms of PRES or RCVS should seek medical help immediately.
Severe forms of the condition will need to be treated in hospital.
After brain scans, sometimes more research is needed.
According to the NHS, this includes blood tests and a spinal tap (a thin needle is inserted between the bones of the lower spine) to rule out other causes of symptoms that may cause a similar narrowing of the blood vessels.
