Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study

Ajanal, Manjunath; Nayak, Shradda U; Kadam, Avinash; Prasad, Bhavan

doi:10.4103/0974-8520.175539

Cited by 5 publications

(7 citation statements)

References 13 publications

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“…So the overall percentage of patients who have developed SCAR which maybe attributable to Ayurvedic drugs among the total patients with SCAR in this study period is 3.4%. The female to male ratio was 6:1 and this trend of a female preponderance was also seen in a study conducted by Ajanal et al 11 ; though only a slightly higher incidence of adverse drug reactions i.e. (1.3:1) was noticed.…”

Section: Resultssupporting

confidence: 77%

Severe cutaneous adverse reactions to Ayurvedic drugs: a ten year study from a tertiary care centre in South India

Nair¹,

Gmc²

2019

jmscr

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Background: Though the system of Ayurveda has traditionally been acclaimed for its safety, questions are being raised by the scientific community regarding the documentation of safety of Ayurveda Medicines. In this article we address cases of severe cutaneous adverse reactions which are possibly related to Ayurvedic drugs. Materials and Methods: A ten year retrospective study was carried out where the case sheets of patients admitted in dermatology ward of a tertiary care centre with cutaneous drug reactions were reviewed. Cases with clinical diagnosis of severe cutaneous adverse reactions (SJS, TEN, DRESS or AGEP) along with history of intake of Ayurvedic drugs were collected. Demographic data, clinical data, drug history and blood investigations were recorded. ALDEN scoring was done to determine causality and SCORTEN score in cases of SJS-TEN cases to assess severity. Results: Seven out of 179 patients (3.9%) who were admitted with SCAR (4 TEN, 2 SJS and 1 DRESS) had a history of taking Ayurvedic drugs with an ALDEN score of 2-3 implying possible causality. Most were in the 30-40 age group. Female to male ratio was 6:1.Hepatic involvement with elevated liver enzymes and hyperbilirubinemia was the commonest systemic association. Severity of disease based on SCORTEN score in patients with SJS-TEN ranged from 0-4. All the patients were treated with the withdrawal of the culprit drug and administration of systemic steroids and supportive measures. One patient out of the seven, with extensive TEN expired, thus giving a mortality rate of 14.2% Limitations: Being severe cutaneous drug reactions, drug rechallenge was not done Conclusion: Though rare we may have to consider the potential of Ayurvedic drugs to cause even severe cutaneous adverse reactions. However to ascertain causality and identify culprit agents, collaborative studies with Ayurvedic practitioners are needed.

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Section: Resultssupporting

confidence: 77%

Severe cutaneous adverse reactions to Ayurvedic drugs: a ten year study from a tertiary care centre in South India

Nair¹,

Gmc²

2019

jmscr

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“…By complying with QA/QC standards and requirements of regulatory agencies, the quality, efficacy, and safety are ensured [74]. The patient surveillance and biomarker detection are desirable when taking Bhasmas [75]. The personalized medication is important to balance benefits and risks.…”

Section: Chemical Compositions Of Metals Determine Therapeutic Effmentioning

confidence: 99%

“…Clinical efficacy is of utmost importance as exemplified by the use of arsenic sulfide in combination with other drugs in the treatment of acute promyelocytic leukemia [90]. Pharmacovigilance is also important to ensure the safety as exemplified by experience in an Ayurvedic Teaching Hospital ([75]), and in patients taken Tibetan medicines [67, 72, 73].…”

Section: Research Needs and Perspectivesmentioning

confidence: 99%

“…Padma Inc. in Switzerland has been producing selected complex formulas such as Padma-28 (70W) from Tibetan medicine for 40 years, with satisfactory clinical therapeutic effects and safety. By complying with QA/QC standards and requirements of regulatory agencies, the quality, efficacy, and safety are ensured [ 74 ].The patient surveillance and biomarker detection are desirable when taking Bhasmas [ 75 ]. The personalized medication is important to balance benefits and risks.…”

Section: Chemical Compositions Of Metals Determine Therapeutic Effmentioning

confidence: 99%

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Chemical Compositions of Metals in Bhasmas and Tibetan Zuotai Are a Major Determinant of Their Therapeutic Effects and Toxicity

Liu

Zhang

Velagapudi

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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Minerals are alchemically processed as Bhasmas in Ayurvedic medicines or as Zuotai in Tibetan medicines. Ayurveda is a knowledge system of longevity and considers the mineral elixir made from “nature” capable of giving humans perpetual life. Herbo-metallic preparations have a long history in the treatment of various diseases in India, China, and around the world. Their disposition, pharmacology, efficacy, and safety require scientific evaluation. This review discusses the Bhasmas in Ayurvedic medicines and Zuotai in Tibetan medicines for their occurrence, bioaccessibility, therapeutic use, pharmacology, toxicity, and research perspectives. A literature search on Mineral, Bhasma, Ayurvedic medicine, Zuotai, Tibetan medicine, and Metals/metalloids from PubMed, Google and other sources was carried out, and the relevant papers on their traditional use, pharmacology, and toxicity were selected and analyzed. Minerals are processed to form Bhasma or Zuotai to alter their physiochemical properties distinguishing them from environmental metals. The metals found in Ayurveda are mainly from the intentional addition in the form of Bhasma or Zuotai. Bhasma and Zuotai are often used in combination with other herbals and/or animal-based products as mixtures. The advanced technologies are now utilized to characterize herbo-metallic preparations as Quality Assurance/Quality Control. The bioaccessibility, absorption, distribution, metabolism, and elimination of herbo-metallic preparations are different from environmental metals. The pharmacological basis of Bhasma in Ayurveda and Zuotai in Tibetan medicines and their interactions with drugs require scientific research. Although the toxic potentials of Bhasma and Zuotai differ from environmental metals, the metal poisoning case reports, especially lead (Pb), mercury (Hg), and arsenic (As) from inappropriate use of traditional medicines, are increasing, and pharmacovigilance is desired. In risk assessment, chemical forms of metals in Bhasma and Zuotai should be considered for their disposition, efficacy, and toxicity.

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“…Ensuring that a working pharmacovigilance cell exists in every Ayurveda college and hospital will help in generating the data required for future updating and revising these guidelines. One of the available reports that deals with the adverse events observed in one teaching hospital gives an idea about the importance of such an activity [22] . There could be a few drugs that have a narrow therapeutic range where, the difference between toxic and therapeutic doses could be very small.…”

Section: Clinical Monitoring Guidelinesmentioning

confidence: 99%

Ayurveda formulations: A roadmap to address the safety concerns

Patwardhan

Pathak

Acharya

2017

Journal of Ayurveda and Integrative Medicine

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It is a matter of serious concern that the number of case reports pointing at a possible association between the clinical toxicity and the use of Ayurveda formulations is increasing significantly over the years in scientific medical literature. Though most of these cases are connected with the presence of heavy metals such as lead, mercury and arsenic in these formulations, there are also reports suggesting toxicity due to the presence of toxic chemicals of herbal origin. In the year 2008, the Government of India took an initiative of establishing the National Pharmacovigilance Programme for Ayurveda, Siddha and Unani drugs in a structured way. However, due to lack of sustained support, this program has now become defunct. This issue is of vital importance and needs to be addressed effectively on a priority basis. In this communication, we propose the following crucial policy interventions to be introduced at different levels: a. Amendments to Drug and Cosmetic Act, b. Issuing consumer guidelines, c. Issuing prescription guidelines, d. Issuing clinical monitoring guidelines, e. Implementation of good manufacturing guidelines, f. Promoting documentation of clinical safety, g. Identifying the sources of contamination, and, h. Provision for stringent punishment. If these policy interventions are taken up and implemented, a significant positive change in the scenario can be expected in the near future.

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Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study

Cited by 5 publications

References 13 publications

Severe cutaneous adverse reactions to Ayurvedic drugs: a ten year study from a tertiary care centre in South India

Severe cutaneous adverse reactions to Ayurvedic drugs: a ten year study from a tertiary care centre in South India

Chemical Compositions of Metals in Bhasmas and Tibetan Zuotai Are a Major Determinant of Their Therapeutic Effects and Toxicity

Ayurveda formulations: A roadmap to address the safety concerns

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