Adverse Event Associated with Turmeric Preparation :Consumer Reporting Experiences

byMrs. Wimon Suwankesawong

Thai Adverse Product Reaction Monitoring Center Food and Drug Administration

Thailand

Turmeric, Curcuma longa Linn., is a h erbal plant extensively cultivated in T

hailand

1Introduction ( )

Its rhizome is used intraditional medicines for many indicationsMajor chemical constituents of rhizomes

are volatile oil 6( %) and (5 %)

In 1999,the single formulation of turmeric was selected as herbal medicine for the Thai National Essential Drug List for anti-flatulence

- 250 mg powder of dried turmeric rhizome

2Introduction ( )

Turmeric is believed to be ef fective and safe

adverse effect : nausea, vomiting diarrhea constipation, pruritus, h eadache, dizziness, palpitation

Curcumin, an active ingredi ent in t urmeric, has been re

ported to induce gastric ulce ration in rats

(3)Introduction

Objective

To investigate and categorize adverse events associated wi

th turmeric preparations

SSSSS SSSSSS - Prospective time series desig

n

(1)

Setting and Study population Patients who were prescribed

turmeric products during April 1, 2001-March 30,2003 in fifty government hospitals were enrolled in the study

Data collection Hospital pharmacist interviewed the

patients to collect baseline data Patients were asked to send back a

postcard with structured questions after1-2 weeks to report their experience using turmeric products

Effectiveness Adverse event

2Method ( )

Demographic Data Patients taking turmeric product 978=

Lost to follow up 342= (35%)

Study population 636=

Patient with adverse event 220 34= ( .6%)

Female = 158 (71.8%)

Mean age 48 Underlying disease 126

Number of adverse events 479 None of serious adverse event

Adverse Events classified by System Organ Class (1)

- System organ classes n=479 (%)

GI system disorders 186 3883( . )

abdominal pain, n/v, anorexia, diarrhea

- Body as a whole general 148 3090( . )

disorders fatigue, chest discomfort,

therapeutic response decreased(ineffective)

Adverse Events classified by System Organ Class (2)

- System organ classes n=479 (%)

Central & peripheral nervous 5 1 (1 0 .8 2 )

system disorder headache, dizziness

Respiratory system disorders 48 1002( . )

dyspnoea,cough

Skin and appendages disorders 32

084( . ) rash, pruritus

Discussion Lost to follow up

Direct consumer reporting system : awareness of reporting

None or Mild adverse event GI system disorder

Volatile oil : stomach distress Patients with underlying disease :

Peptic Ulcer Quality of products : ineffective Patient Compliance : low

Conclusion & Recommendaton

Single turmeric product : safe

GI system disorder Further study

GI system disorder associated with single turmeric preparation are needed

be used to Label the product accurately to promote national and safe use of the product