Adverse Event Associated with Turmeric Preparation :

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Adverse Event Associated with Turmeric
Preparation Consumer Reporting
Experiences by Mrs. Wimon Suwankesawong Thai
Adverse Product Reaction Monitoring Center Food
and Drug Administration Thailand
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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 of rhizomes are
  volatile oil (6) and curcumenoids(5)

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Introduction (2)

• 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

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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

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Objective

• To investigate and categorize adverse events
  associated with turmeric preparations

Study design

• Prospective time-series design

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Method (1)

• Setting
• Fifty government hospitals
• Study population
• Patients who prescribed turmeric product during
  April 1, 2001-March 30,2003

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Method (2)

• Data collection
• Hospital pharmacist interviewed the patients to
  collect baseline data
• Patients were asked to send back a postcard with
  formalized questions after
• 1-2 weeks to report their experience using
  turmeric products
• Effective
• Adverse event

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Result (1)

• Patients taking turmeric product 978
• Lost follow up 342 (34.96)
• Study population 636
• Patient with adverse event 220 (34.59)
• Female 158 (71.8)
• Mean age 48
• Underlying disease 126
• Number of adverse events 479

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Results (2)

• AEs System-organ classes n479 ()
• 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)

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Results (3)

• AEs System-organ classes n479 ()
• 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

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Discussion

• Lost of follow up
• Direct consumer reporting system
• Mild adverse event
• GI system disorder
• Volatile oil stomach distress
• Follow up period 2 week (too short)
• Quality of products ineffective
• Compliance low

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Conclusion

• Single turmeric product safe
• GI system disorder
• Further study
• GI system disorder associated with single
  turmeric preparation
• Labeled on product insert