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.)

Back to Nature

¡ Worldwide increase in consumption

of herbal remedies

¡ Poor evidence- based

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

Results

Medicinal

Nutritional

5%

95%

Registration Categories of the

Examined 100 Herbal Products

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

Assessment of Product Inserts (n=56)

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

Thank you

Questions?