Summary of cases for which causality assessment was undertaken
| Case | Age Ethnicity Sex | Tobacco use; alcohol use; ethnicity | Prescription and over-the-counter drugs (oral administration unless otherwise specified) | Natural health products† (brand name, where known) (oral administration unless otherwise specified) | Adverse event description | Outcome of Causality assessment |
|---|---|---|---|---|---|---|
| 1 | 68-year–old Caucasian Female | None; none; | Amlodipine, bisoprolol, ezetimibe, levothyroxine, ramipril, rosuvastatin, clopidogrel | Flaxseed oil, omega-3 fatty acids, vitamin D, calcium/magnesium/zinc* | Severe bruising | Likely caused by NHP |
| 2 | 25-year–old Caucasian Female | None; <1 drink/week | Cyproterone acetate/ethinyl estradiol*, ketorolac, escitalopram | Calcium carbonate, vitamin D, multivitamin | Nausea and vomiting | Likely caused by NHP |
| 3 | 8.5-year–old Chinese Female | None; none | Sertraline, polyethylene glycol, metoclopramide, mineral oil, fluticasone propionate inhalation aerosol | Chinese herbal tea; laboratory analysis detected camphor | Cardiac arrest | Possibly caused by NHP |
| 4 | 2-year-old Spanish Female | None; none | None | Ganoderma lucidum/cocoa (Cocozhi)*; laboratory analysis detected caffeine | Status epilepticus | Possibly caused by NHP |
| 5 | 6-month–old Caucasian/Aboriginal Female | None; none | Ibuprofen | Belladonna/Chamomilla vulgaris/Ferrum phosphoricum (Camilia—Canadian formulation)*, Chamomilla/Phytolacca decandra/Rheum officinale (Camilia—USA formulation)*, Calcium carbonicum Hahnemanni/Pulsatilla/Chamomilla/Plantago major/Dulcamara/Belladonna (Viburcol)*; no significant findings detected by laboratory analysis | Absence seizures and status epilepticus | Possibly caused by NHP |
| 6 | 16-year–old Caucasian/Metis Female | None; 6–7 drinks/week | None | Rosemary, honey, witch hazel, fenugreek seed, black seed, King Solomon seed, ginseng powder, damiana leaves, marshmallow, sage, juniper berries, chamomile flowers, cloves, cinnamon, spearmint, thyme (RespirActin)* | Shallow breathing, fatigue and convulsions | Possibly caused by NHP |
| 7 | 60-year–old Caucasian male | None; none | Gabapentin, telmisartan/hydrochlorothiazide*, simvastatin, amlodipine, naproxen, oxycodone/acetaminophen, acetaminophen/codeine/caffeine* | Vitamin C | Vertigo | Unlikely caused by NHP |
| 8 | 65-year–old German/French Female | None; <1 drink/week | Amlodipine, lisinopril, hydrochlorothiazide, cyclobenzaprine, betahistine | Vitamin D, calcium, magnesium, 14-mushroom complex | Vertigo, head ‘pain and fullness’ | Unlikely caused by NHP |
| 9‡ | 58-year–old British Female | None; none | Amlodipine | Several combination products consisting of >55 individual NHP ingredients | Severe epigastric pain | Unlikely caused by NHP |
*Denotes combination products as indicated by a ‘/’ between ingredients.
†Products and ingredients are as stated on the manufacturers’ product package.
‡Details of case, including all NHPs and their ingredients, have been published elsewhere.49
NHP, natural health product.