https://www.straitstimes.com/singapore/benefits-of-pseudoephedrine-decongestant-outweigh-risks-hsa
2025-01-17
SINGAPORE – The Health Sciences Authority (HSA) said the benefits of pseudoephedrine, a decongestant found in 31 medications here, outweigh the risks it poses, in response to reports overseas of adverse effects.
The regulatory body told The Straits Times on Jan 15 that it has not received any local report of severe adverse effects associated with medicines containing pseudoephedrine, “which have a widespread and long history of use”.
Such medications include Clarityn-D, Telfast-D and Sudafed.
Pseudoephedrine is commonly used to clear a blocked nose. It constricts blood vessels in the nose and sinuses, shrinking swelling and draining fluids to allow for easier breathing. But the drug also tightens blood vessels throughout the body, and can raise blood pressure.
The HSA spokesperson said: “If consumers have symptoms such as severe headaches, nausea, vomiting, visual disturbances, seizures and altered mental status after taking pseudoephedrine-containing medicines, they are advised to stop the medicine and seek immediate medical attention.”
HSA had published a safety alert in April 2024 on the rare risk of posterior reversible encephalopathy syndrome (Pres) and reversible cerebral vasoconstriction syndrome (RCVS), which have been reported overseas as being associated with pseudoephedrine.
These two conditions are rare but potentially fatal.
Pres can cause visual problems, seizures and headaches, and affects thinking. It is treatable with early diagnosis. Symptoms of RCVS are very much like those of stroke, as it is caused by blood vessels that suddenly spasm and constrict. Globally, there have been a few deaths linked to these side effects.
British pharmaceutical GSK announced in 2023 that it planned to stop producing its popular Zyrtec-D, an antihistamine and decongestant that contains pseudoephedrine, citing business reasons. However, this raised concerns that the move was sparked by the link to Pres and RCVS.
Doctors say that while medication with pseudoephedrine is generally safe for the majority of people, there are some who should be cautious, such as those with heart disease or glaucoma.
Dr Melvyn Wong, medical director of Raffles Medical, said such medicines are highly effective in relieving nasal and sinus congestion. “Their ability to shrink swollen nasal mucosa and reduce inflammation makes them particularly useful for short-term relief in conditions such as the common cold, sinusitis, or allergic rhinitis,” he said.
However, he noted that doctors are more cautious about prescribing them to patients who are at higher risk of getting Pres or RCVS. Such patients include those with uncontrolled hypertension, heart disease or migraines.
The risk of adverse effects is carefully weighed against the benefits, and should the patient be prescribed the drug, they must be given clear instructions, both verbal and written, to minimise misuse and adverse effects, Dr Wong said.
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Because the medication enters the bloodstream, it affects the entire body and could lead to side effects like increased heart rate, elevated blood pressure, or, in rare cases, conditions such as Pres or RCVS.
There are alternative treatments for patients at higher risk of side effects, said Dr Wong. Some options include nasal sprays like oxymetazoline, which provide effective relief with fewer systemic effects, and saline nasal sprays or irrigation, which are both safe and help moisten the nasal passages, flush out allergens and reduce congestion.
But he warned that while nasal sprays do not affect the entire body, they can be used for only three to five days. Using them for longer periods could cause rebound congestion, where the nose feels itchy and stuffy.
Dr Wong added: “For patients with multiple symptoms, combinations with antihistamines and analgesics (such as paracetamol or ibuprofen) may be more suitable without pseudoephedrine.”
In an earlier report, Dr John Cheng, chief medical officer of Healthway Medical Group, told ST that severe reactions “are exceedingly rare”.
He explained that such reactions are “associated with multiple contributing factors, such as pre-existing conditions, excessive dosing, or concurrent use with other medications that affect the central nervous system or blood pressure”.
Dr Cheng added that it is important for patients to strictly adhere to the dosing instructions and to speak to their doctors or pharmacists before starting on the medicine.
In its statement, HSA said it “will continue to monitor the situation and take the necessary regulatory actions if there are any significant safety concerns detected locally or globally.”
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