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