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Adverse Event Associated with Turmeric Preparation : Consumer Reporting Experiences by

Adverse Event Associated with Turmeric Preparation : Consumer Reporting Experiences by Mrs. W i mon Suwankesawong Thai Adverse Product Reaction Monitoring Center Food and Drug Administration Thailand. Introduction (1).

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Adverse Event Associated with Turmeric Preparation : Consumer Reporting Experiences by

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

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

  3. Introduction (2) • In 1999,the single formulation ofturmeric was selected as herbal medicine for the Thai National Essential Drug List for anti-flatulence - 250 mg powder of dried turmeric rhizome

  4. Introduction (3) • 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

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

  6. 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

  7. Method (2) 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

  8. 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

  9. Adverse Events classified by System Organ Class(1) • System-organ classes n=479 (%) • GI system disorders 186 (38.83) • abdominal pain, n/v, • anorexia, diarrhea • Body as a whole-general 148 (30.90) • disorders • fatigue, chest discomfort, • therapeutic response • decreased(ineffective)

  10. 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

  11. 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

  12. 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

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