Cold medicine facing over-the-counter ban pending brain disease probe

Sudafed could become a prescription-only medicine or end up pulled from pharmacy shelves altogether as regulatory authorities investigate a possible connection to a rare but deadly brain disorder. Medical regulators are investigating whether they should change rules on selling pseudoephedrine due to its links to two reported incidents where people developed rare conditions that cause strokes. Officials are “reviewing available evidence” for several branded products, including other decongestants made by Benylin, Nurofen and Day & Night Nurse.

Pseudoephedrine is an ingredient in several decongesting medications that reduces swelling in blood vessels that block nasal cavities.

Most pseudoephedrine products are available over the counter, with people able to buy tablets or liquids that help ease the symptoms of a cold.

But regulators will investigate the relationship between the decongestant and two rare conditions; posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

The Pharmaceutical Journal first identified the connection and called on regulators to decide whether they should change marketing authorisations for “pseudoephedrine-containing medicines”.

The British Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) will launch reviews after indicating “concerns” about the connections between the medication and conditions.

Speaking to the Daily Mail, a spokesman for the MHRA said the agency would “provide any further advice as appropriate”.

They added that anyone concerned about the products should “speak to their pharmacist or doctor”.

While it is possible the review could see pseudoephedrine products banned, the Mail added that Whitehall sources said it is unlikely rules surrounding the decongestant would change.

The EMA will decide whether European authorities maintain, vary, suspend or withdraw marketing authorisations for pseudoephedrine-containing medicines.

The MHRA said cases of PRES and RCVS are “very rarely reported with these medicines” but did not provide an approximate number.

PRES is defined by brain swelling, which causes headaches, vision issues, mental changes, and seizures.

The swelling can occasionally prove fatal, but people diagnosed with PRES usually recover.

RCVS is characterised by sudden constriction of vessels in the brain that causes severe “thunderclap” headaches, with strokes and brain bleeds rarer but possible.

Again, people usually recover from the condition, but it can cause life-threatening complications.

Consumer groups maintain that pseudoephedrine products are safe to consume, but they have known side effects.

They include feeling or being sick, trouble sleeping, headaches and more, and regulators limit the amount of pseudoephedrine people can buy without a prescription to 720mg.

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