New safety warnings: BioCeuticals’ ArmaForce to bear new labelling after taste-loss complaints
The new labelling will state clearly the dosage recommendation for the product, which is one tablet per day for a maximum of two weeks.
ArmaForce with the new labelling will be out in the market in September, a BioCeuticals spokeswoman told NutraIngredients-Asia.
“BioCeuticals has taken the proactive decision to update product labels with a new safety warning,” she said. The product is currently sold from behind the counter, which means that it is only available for sale upon a pharmacist's advice.
The new label will also contain the warning about the product’s potential side effect of taste disturbance.
In the past few months, there has been a spike in consumers who reported adverse reactions relating to taste loss after taking the product.
The spokeswoman said the spike in reported adverse events was due to the increased purchase of ArmaForce in March and April.
In fact, the product was the firm’s best-selling immune health product during that period.
As taste loss is one of the symptoms of COVID-19, there were concerns that the side-effect coming from the use of this product might lead to a misdiagnosis.
According to the spokeswoman, the side effect was coming from the intake of andrographis, the active ingredient in ArmaForce.
The botanical is used to relieve symptoms of common cold, including sore throat, runny nose, headache, and fatigue.
The company’s investigations have suggested that the spike in reported taste-loss cases might be due to the product being purchased without healthcare professional advice.
Consumers could also have used the product for prolonged periods at high doses as they attempted to strengthen their immunity in light of COVID-19.
Nonetheless, the company has advised consumers not to take the side-effect of taste loss lightly.
“Consumers who experience any symptoms of taste disturbance while taking ArmaForce should stop taking the product as soon as possible and seek medical advice from their healthcare practitioner as soon as possible,” the spokeswoman said.
There are some interim arrangements made as BioCeuticals prepare the products with the new labelling.
For instance, interim labels which recommended the “dosage of 1 tablet per day” and taste disturbance warnings are already out in the market.
At the same time, pharmacists and healthcare professionals had been reminded of adhering to prescribing guidelines. They should also provide consumers with information on how to use the product safely.