Adverse Event Associated with Turmeric Preparation : Consumer Reporting Experiences by Mrs. Wimon Suwankesawong Thai Adverse Product Reaction Monitoring Center Food and Drug Administration Thailand

 Turmeric, Curcuma longa Linn., is a herbal plant extensively cultivated in Thailand Introduction (1)  Its rhizome is used in traditional medicines for many indications  Major chemical constituents of rhizomes are volatile oil (6%) and curcumenoids(5%)

 In 1999,the single formulation of turmeric was selected as herbal medicine for the Thai National Essential Drug List for anti-flatulence mg powder of dried turmeric rhizome Introduction (2)

 Turmeric is believed to be effective and safe  adverse effect : nausea, vomiting diarrhea constipation, pruritus, headache, dizziness, palpitation  Curcumin, an active ingredient in turmeric, has been reported to induce gastric ulceration in rats Introduction (3)

Objective  To investigate and categorize adverse events associated with turmeric preparations Study design  Prospective time-series design

Method (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 after 1-2 weeks to report their experience using turmeric products  Effectiveness  Adverse event Method (2)

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 disorders186 (38.83)  abdominal pain, n/v, anorexia, diarrhea Body as a whole-general 148 (30.90) disorders  fatigue, chest discomfort, therapeutic response decreased(ineffective)

Adverse Events classified by System Organ Class (2) System-organ classes n=479 (%) Central & peripheral nervous 51 (10.82) system disorder  headache, dizziness Respiratory system disorders 48 (10.02)  dyspnoea,cough Skin and appendages disorders 32 (0.84)  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