Adulterated Traditional-Herbal Medicinal Products and Its Safety Signals in Malaysia

Abstract

Background

Usage of traditional-herbal medicines (THM) for various illnesses has been increased around the world, so does the adulteration of these products with hazardous compounds. There are limited Malaysian data that have been published on the characteristics trend and adverse events associated with adulterated THM products.

Aim

This study described characteristics of adulterated THM products in Malaysia and aimed to quantify THM products’ safety signals of adverse reactions (ARs).

Methods

THM products that were seized by Pharmacy Enforcement Division between 2008 and 2014 were extracted and analysed for 59,440 THM products. Of these, only 6452 THM products with complete information were included in the final analyses. Safety signalling tools were used to measure AR signals from AR reports obtained from the National Pharmaceutical Regulatory Agency Adverse Drug Reaction Database.

Results

More than half of adulterated THM products originated from countries outside of Malaysia, with the majority were from Indonesia. The most common claimed indication of adulterated THM products was for pain and fever relief, while steroids were the most common adulterant. AR signals were generated for cough and cold products for respiratory and thoracic disorders, weight-loss products for cardiac disorders, and women’s health products for reproductive and breast disorders.

Conclusion

Health authorities from various fields can work collaboratively by implementing strategic actions that include the use of safety signalling tools to curb the increasing number of adulterated THM products in the Malaysian market.

Keywords:

• adulterated
• safety
• signal
• traditional
• products

Acknowledgment

We would like to thank Malaysia Ministry of Health (MOH) Pharmacy Enforcement Division and National Pharmaceutical Regulatory Agency (NPRA) for providing data used in this study. The study results, discussion and conclusion are from authors and do not represent the opinion of MOH.

Disclosure

The authors declare that they did not receive funding nor have no other potential conflicts of interest for this work.