The information in this article is derived from a safety signal generated from reports of suspected adverse events available in the Malaysian Pharmacovigilance Database (QUEST). The aim of this article is to raise public awareness and encourage more reporting. It is important to note that a signal does not indicate a direct causal relationship between a side effect, but is essentially only a hypothesis that, together with data and arguments, justifies the need for further assessment.

Background

Aloe vera plants have been traditionally used for various purposes, including their health benefits for external treatment of wounds, burns, and skin irritations, as well as and for cosmetic and functional food purposes.^1-2 The clear thick gel from the centre of fresh leaves is known for its healing and soothing properties, while the latex (yellowish bitter exudate) has laxative effects.

In Malaysia, Aloe vera-containing products are available as registered traditional products or health supplements in various forms, such as capsules, tablets, gel, and ointment, as well as notified cosmetic products in cream and lotion forms.³ There are currently 76 registered products containing Aloe vera as a single active ingredients or in combination with other ingredients that are available in oral dosage forms in Malaysia. Of these, 56 products are classified as traditional products, while 20 are classified as health supplements.

From 2016 to 2021, the National Centre for Adverse Drug Reactions Monitoring, NPRA received 15 local adverse reaction reports related to the consumption of oral Aloe vera-containing products.⁴

Case Reports Related to the Safety Issue⁴

From February 2020 to the present date, the NPRA has received five (5) cases of kidney-related adverse reactions possibly linked to the consumption of oral Aloe vera products containing only a single active ingredient. The reactions reported include increased levels of creatinine and urea in the blood (loss of kidney function), acute kidney injury (damage to the kidneys occurring suddenly), and worsening of existing kidney problems. These adverse reactions were observed as early as one (1) day and up to five (5) months after consuming oral Aloe vera-containing products.

The affected patients were between 35 and 65 years of age. Most of them were concurrently taking other medications and had other underlying medical conditions, including existing reduced kidney function, high blood pressure, abnormal blood cholesterol levels, heart disease, diabetes, or gout.

All five (5) patients who experienced these adverse reactions were hospitalised. Among them, two (2) patients were reported to have shown signs of recovery, while the others had not recovered at the time of reporting after stopping the suspected products.

Safety Concerns

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 will continue to closely monitor this safety issue and keep the public informed of any significant findings.

Advisory^1,5

• Be aware that there have been local reports of kidney-related adverse reactions in some individuals following the consumption of oral Aloe vera-containing products. This risk could be higher in those with underlying medical conditions, including reduced kidney function.
• Consult with your health care providers before using oral Aloe vera-containing products if:
  • You have any existing medical conditions, especially kidney diseases;
  • You are pregnant; or
  • You plan to use it in children under 12 years old.
• Consult your health care providers if you experience any unusual symptoms after taking any oral Aloe vera-containing product, especially those related to your kidneys, such as decreased urine output, swelling, shortness of breath, nausea, or fatigue. 
• Report all side effects suspected to be related to oral Aloe vera-containing products to the NPRA [Consumers > Consumer Side Effect Reporting Form (ConSERF)]

References

1. World Health Organization (WHO) monograph on selected medicinal plants .1999; 1: 33-49 [cited 2023 Jun 15]. Available from https://apps.who.int/iris/handle/10665/42052
2. Guo X, Mei N. Aloe vera: A review of toxicity and adverse clinical effects. J Environ Sci Health C Environ Carcinog Ecotoxicol Rev. 2016 Apr 2;34(2):77-96. Available from: https://doi.org/10.1080%2F10590501.2016.1166826
3. National Pharmaceutical Regulatory Agency (NPRA). Malaysian Product Registration Database (QUEST 3+) [Internet]. 2023 [cited 2023 Jun 15]. Available from https://www.npra.gov.my
4. National Pharmaceutical Regulatory Agency. The Malaysian National ADR Database (QUEST 3+) [Internet]. 2023 [cited 2023 Jun 15]. Available from https://www.npra.gov.my (access restricted).
5. European Union Herbal Monograph on Aloe barbadensis Mill. and on Aloe (various species, mainly Aloe ferox Mill. and its hybrids), folii succus siccatus. 2016 Nov [cited 2023 Jun 15]. Available from https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-aloe-barbadensis-mill-aloe-various-species-mainly-aloe-ferox_en.pdf

Disclaimer: The information in this article is intended for general informational purposes only and is not specific to any particular product. Patients and consumers should consult their healthcare providers for personalised advice.

Written by: Jeeven Raj Rajagopal
Reviewed/Edited by: Choo Sim Mei, Nora Ashikin Mohd Ali, Norleen Mohamed Ali, Dr. Sunita Bavanandan