Between February 2020 and August 2023, five cases of kidney-related adverse reactions that were “possibly linked” to the consumption of oral aloe vera products containing only a single active ingredient were received, said the National Pharmaceutical Regulatory Agency (NPRA).
The adverse reactions included acute kidney injury, worsening of existing kidney problems, and an increased levels of creatinine and urea in the blood, which signals a loss of kidney function. All five were hospitalised as a result of the adverse effects.
These reactions were observed one day or even up to five months after consuming oral aloe vera-containing products, the NPRA said.
The cases involved individuals between 35 and 65 years old.
Most of them have underlying medical conditions such as reduced kidney function, high blood pressure, abnormal blood cholesterol levels, heart disease, diabetes, or gout, and many were on medications.
The NPRA has advised consumers to exercise caution when considering to ingest aloe vera products.
However, it acknowledged that there is a lack of scientific data showing that aloe vera could induce adverse reactions related to the kidneys.
“While there is currently insufficient scientific data concerning Aloe vera-induced adverse reactions specifically related to the kidneys, the NPRA would like to advise consumers to exercise caution when considering the use of oral Aloe vera-containing products.
“This is particularly important for patients with underlying medical conditions, including reduced kidney function,” the NPRA said, adding that it would continue to monitor the situation.
It also advised consumers who are pregnant or below 12 years old to consult health care providers before taking oral aloe vera-containing products.
Between 2016 and 2021, it received 15 adverse reaction reports related to the consumption of aloe-vera containing products.
In Malaysia, products containing aloe vera for oral consumption could be registered as traditional products or health supplements in the form of capsules, tablets, and gel etc.
According to the NPRA, there are 20 such health supplements and 56 traditional products registered.
Regulations elsewhere
From January 1 this year, Taiwan is requiring aloe vera raw materials used in food to be derived from the leaves of the aloe ferox and aloe vera species.
Aloin, which is derived from the sheath cells of the leaves, should not exceed 10 parts per million (ppm) in a food product.
The Taiwan Food and Drug Administration said that international scientific research has reported that long-term consumption of hydroxyanthracene derivatives foods or dietary supplements was linked to safety concerns.
The European Commission also announced in 2021 a ban on botanical species containing hydroxyanthracene derivatives, including aloe extracts, in foods.