Reporting a Problem With an Ayurvedic Product or Treatment

If it is urgent, do this first

Reporting is for after you are safe. For trouble breathing, swelling of the face, lips or throat, fainting, chest pain, a seizure, confusion or heavy bleeding, call 911 in the US (or your local emergency number) before anything else. If you think someone swallowed something harmful, call Poison Help at 1-800-222-1222 in the US; see Poison Help by country for other places. Then tell a clinician what the product or treatment was. For warning signs and what to do, see warning signs after Ayurvedic treatment.

Why a report helps

Regulators say reports from the public help them spot unsafe products they could not otherwise see. The FDA, for example, says it does not approve dietary supplements before sale, so reports of health-related reactions help it evaluate the marketplace and act. [1] A survey of Ayurveda physicians and teachers in one Indian state found that good attitudes toward reporting were not matched by actual reporting, which is another reason patient reports matter. [2]

What to gather before you report

• The product name, brand, ingredients on the label and any lot or batch number; keep the package and photograph the label.
• Where and when you bought it, and what you paid; keep the receipt or order page.
• When you started, how much and how often you used it, and what else you were taking.
• What happened, when it started, and whether it improved after stopping.
• Names of any clinicians who treated you.

Do not throw the product away, and do not keep using it if you had a serious reaction. The FDA's advice is to stop using the product immediately if it caused a serious reaction or illness. [1]

How to report, by place

United States details. The FDA lists examples of serious reactions: itching, rash, hives, throat or tongue swelling, wheezing, low blood pressure, fainting, chest pain, shortness of breath and irregular heartbeat. [1] Others include blood in urine, stool or vomit, abnormal bleeding from the nose or gums, fatigue, loss of appetite and yellowing of the skin or eyes. [1] The FDA says complete reports help most, but even pieces of information can help identify potentially dangerous products. [1]

United Kingdom. The Yellow Card scheme is run by the Medicines and Healthcare products Regulatory Agency. [3] The site's front page lists medicines, vaccines, devices and other products; if your product does not obviously fit, tell the scheme what you used and ask. [3]

Canada. Health Canada's consumer page lists traditional medicines such as Ayurvedic medicines among the natural health products you can report on. [4] A health care provider can also help you submit a report.

India. India's pharmacovigilance programme covers Ayurveda, Siddha and Unani drugs. [5] A survey of Ayurveda physicians and teachers in one Indian state found that positive attitudes toward reporting were not reflected in actual reporting. [2] If you are in India, ask your treating doctor to file a report, and also consider telling the pharmacovigilance centre directly.

Reporting a treatment or a practitioner

No source we read describes a single complaint route for Ayurvedic treatments in the United States, where NCCIH says there is no significant regulation of Ayurvedic practice or education and no state license is required of Ayurvedic practitioners. [6] The World Health Organization's practice benchmarks say adverse effects should be reported within the specified time to local health authorities and pharmacovigilance centres, and that clinics should have a plan to manage adverse events. [7] So:

1. Tell the clinic in writing, and keep a copy.
2. Tell your own doctor or pharmacist so the event is on your record.
3. If the practitioner also holds a license in another health profession (for example as a doctor or nurse), ask that licensing body how complaints are handled.
4. Report any product used in the treatment through the routes above.

For a broader guide see reporting adverse events from therapies and practitioners and side effects, allergic reactions and reporting. To understand who regulates what, see how Ayurvedic products are regulated.