Health Authority Stands Firm: Pseudoephedrine’s Benefits Outweigh Risks Despite Global Concerns

SINGAPORE – In a recent statement, Singapore's Health Sciences Authority (HSA) confirmed that the benefits of pseudoephedrine, an active ingredient found in numerous over-the-counter decongestants, significantly outweigh the associated risks. This announcement comes as overseas reports highlight possible adverse effects linked to the medication.

Speaking to The Straits Times on January 15, the HSA emphasized that no local reports have surfaced concerning severe adverse events tied to pseudoephedrine, which has been widely used for decades in products like Clarityn-D, Telfast-D, and Sudafed.

Pseudoephedrine is primarily recognized for its effectiveness in alleviating nasal congestion by constricting blood vessels in the nasal passage, resulting in reduced swelling and improved airflow. However, the drug's systemic effects can increase blood pressure, prompting caution in specific populations.

In light of emerging global studies, the HSA had released a safety alert in April 2024, addressing the rare risk of two serious conditions: posterior reversible encephalopathy syndrome (Pres) and reversible cerebral vasoconstriction syndrome (RCVS). Although rare, cases of these syndromes have been reported, raising concerns about their potential link to pseudoephedrine use. Both conditions present with serious symptoms such as seizures and severe headaches and may result in lasting neurological impact if not diagnosed promptly.

The pharmaceutical company GSK also generated discussion in 2023 when it announced plans to discontinue Zyrtec-D, a popular antihistamine and decongestant combination. While GSK cited business reasons for the decision, speculation arose about whether concerns over potential links to Pres and RCVS influenced the move.

Healthcare professionals generally deem pseudoephedrine safe for a significant majority of users; however, certain populations – such as individuals with existing heart conditions or glaucoma – are urged to exercise caution.

Dr. Melvyn Wong, medical director at Raffles Medical, explained, "These medications are highly effective in providing relief from nasal and sinus congestion," underscoring their importance for short-term relief during illnesses like the common cold or allergic rhinitis. Nevertheless, he advised close monitoring for patients with high-risk conditions including uncontrolled hypertension, heart disease, or severe migraines. Such patients may require alternative treatments to mitigate the risk of adverse effects.

For individuals prone to side effects, alternatives do exist. Options include topical nasal sprays, such as oxymetazoline, which deliver localized relief with fewer systemic complications. Saline nasal sprays are also recommended, as they help to moisten nasal passages and flush out allergens without the risk of systemic side effects. However, caution is necessary with the duration of use for nasal sprays; prolonged use beyond three to five days may cause rebound congestion.

In addition, Dr. Wong suggested that patients experiencing multiple symptoms may find more suitable relief through combinations of antihistamines and analgesics, which alleviate symptoms without employing pseudoephedrine.

Echoing similar sentiments, Dr. John Cheng, chief medical officer at Healthway Medical Group, emphasized that severe reactions to pseudoephedrine are “exceedingly rare,” typically arising from a combination of pre-existing health issues, excessive dosages, or interactions with other medications.

The HSA reiterated its commitment to safety, stating, “We will continue to monitor the situation and take any necessary regulatory action if significant safety concerns arise, whether locally or globally.”

As discussions around pseudoephedrine continue, it’s more important than ever for users to consult healthcare providers about their individual health situations and adhere strictly to prescribed dosages. So, while pseudoephedrine remains a staple in many medicine cabinets, being informed about its risks and benefits is crucial for safe usage.