Zyrtec-D no longer available due to health risk concerns
Antihistamine and decongestant medication Zyrtec-D is no longer being produced and, in most markets including Singapore, is no longer available for sale at most clinics and pharmacies.
This follows a decision by the drug’s manufacturer, GSK, to discontinue its production. The pharmaceutical giant informed retailers and healthcare professionals worldwide of its decision in August 2023.
The medication contains pseudoephedrine, which acts as a decongestant. There has been concern in recent years because of pseudoephedrine’s link to posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
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.
According to the Cleveland Clinic in the US: “Up to 30 per cent of people with RCVS have a minor, lasting loss of an ability, such as lingering muscle weakness or balance difficulties. About 8 per cent of people have a more severe lasting problem.”
Pseudoephedrine is sold under many brand names, such as Sudafed, Congestaclear and Pseudocot. There are also dozens of medications that include pseudoephedrine as one of their ingredients, such as Zyrtec-D.
The company said the move was part of its “continual process to optimise the portfolio of medicines”.
In March, GSK sent a letter to healthcare professionals in Singapore, alerting them to the possible risk of PRES and RCVS.
It said there have been a few cases of PRES and RCVS overseas in patients who had taken medications containing pseudoephedrine. The letter added: “Most cases resolved following discontinuation and appropriate treatment.”
The Health Sciences Authority, which regulates medications and medical products here, said products containing pseudoephedrine have been registered in Singapore since 1989, with 31 products currently registered.
A GSK spokesman told The Straits Times that the company’s global safety board has concluded that pseudoephedrine is associated with a risk of developing PRES and RCVS.
He said: “Following considered assessment of the risk, GSK’s global team has determined that the safety profile of Zyrtec-D remains favourable, which is to say that the likelihood of an ‘adverse event’ occurring is low, and the benefit of the product outweighs the risk of its availability in the market.
“As such, it is not presently considered necessary that Zyrtec-D be formally recalled from the market.”
He added that there have been no cases of PRES or RCVS linked to Zyrtec-D in Singapore.
Other forms of Zyrtec, without the decongestant, are still on the market.
The European Medicines Agency warned of the risk in January and requires medications with pseudoephedrine to carry a warning.
It also urged people with severe or uncontrolled blood pressure, or those who suffer from chronic kidney disease or kidney failure, not to take medications containing pseudoephedrine as these are risk factors for developing PRES or RCVS.
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