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S. El-Masry, PharmSci 2012
Post-Marketing Surveillance of Some Herbal Remedies Marketed in
Egypt: Paediatric Preparations
Sawsan El-Masry* ,Mohammed Bahey-El-Din**Departments of Pharmacognosy * & Pharmaceutical
Microbiology ** Faculty of Pharmacy, Alexandria University, Egypt
Eber’s Papyrus in Hieratic Script
• The complete record of ancient Egyptian medicines• Contains 700 magical formulae and remedies
(1550 B.C.)
Herbal Remedies in Egypt
¡ Majority of products are registered as
Botanical dietary supplements(BDS)
¡ Wide variation in quality
¡ Product inserts claim absolute safety and
efficacy
BDS in Egypt : The Problem
¡ Inadequate regulations
¡ Absence of PMS Systems
l Adverse reactions are underestimated
¡ Poorly informed physician
l Absence of BDS from medical curricula
Objectives
¡ Assess safety of some herbal products
marketed in Egypt for pediatric use
¡ Assess product inserts for evidence of
declared safety and efficacy
¡ Microbiological conformity to USP &
Eur.P.
Methods
¡ Categorization of selected herbal
products according to their pediatric use
or adult use.
¡ Literature survey to assess safety and
efficacy of ingredients highlighted on the
label
Methods
¡ Determination of levels of microbial
contaminants according to USP and
Eur.Ph.
¡ Determination of levels of lead
contamination
Products Examined (n = 100)
¡ 56 for paediatric use
l Thirty (54%) products for infants
¡ Popular products include Guava, thyme,
peppermint, Echinacea, Fennel, Nigella,
Liquorice and Chamomile
Echinacea Products Marketed in Egypt For Paediatric Use (n=18)
¡ All recommended for
upper respiratory tract
infections
¡ Reports suggest it is not
effective in treating
colds in children
Taylor JA et al. JAMA,
2003;290:2924
Guava Products Marketed in Egypt For Paediatric Use (23)
¡ Infant use (14)
¡ Quantities not specified
¡ Antitussive, bronchitis,
mucolytic, pneumonia
¡ Efficacy questionable
¡ No compendial monograph
Ginseng Products in Egypt: Conflicting Claims of Safety & Efficacy
¡ Five Products contraindicate use for
children under 12 years of age
¡ Three products are promoted for
infants and children
Recommended Microbial Limits for Herbal Medicinal Products in USP 34 & Eur. Ph.
Botanical Dietary Supplements
USP Eur. Ph.
Herbal Teas
USP Eur. Ph.
Syrups
USP &
Eur. Ph.
TAMC CFU/g 104 104 - 105 105 107 102
TYMC CFU/g 103 102 - 104 103 105 101
Salmonella
absence10 g 25 g NS 25 g NS
E. Coli
absence10 g 1 g 10 g <103g 1g
Microbiological Quality of Some Herbal Products Marketed in Egypt
PreparationsCFU/g or ml
TAMC TYMC
11 Herbal teas ⃰ boiling water
9 x 104 - 5.5 x107 5x 103 - 3 x106
13 oral aqueousFor paediatric use
‹ 10 – 1.8 X102 ‹ 10 - 10
5 oral botanicals ⃰No boiling water
1 x 103 - 5 x104 ‹ 102 – 5.5 x102
at least one product for paediatric use ⃰
Microbiological Conformity Results According to USP & Eur Ph
product USP 34Conforming
EUR Ph.Conforming
11Herbal Teas 27 % 91%
13 Oral aqueous (syrups) 100% 100%
5 Oral botanicals 100% 80%
Lead Contamination of Some Herbal Products Marketed in Egypt Using Atomic Absorption
Number of Products
Form Pb>(10ppm) Pb≤(10ppm)
8 Teas 3 products(12-15)
5 products(9-10)
9 Dosage forms
4 products*(13-25)
5 products(8-10)
* 2 products are marketed for children
Possible Hazards of Paediatric Herbal Remedies
¡ IQ affected by Lead levels*
¡ Zn & Mg from guava extracts**
¡ Dramatic infections due to microbial
contamination***
¡ Possible herb-drug interactions* Canfield RL et al (2003) N Engl J Med,348:1517
** Okunrobo, LO et al (2010) International J of Health research,3(4):217
*** David Sas et al (2004) The Pediatric infectious disease J.,23 (2):176
Conclusions
¡ Botanical dietary supplements (BDS) for
paediatric use can pose a real health threat
¡ BDS should be subjected to scientific testing
no less rigorous than that required for
conventional medicines
¡ Paediatric products carrying medical claims
should apply evidence-based concepts for
their claims of safety and efficacy
Recommended