Beeswax • Comfrey leaves • Olive Oil • Soybean Oil • Tallow .
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Below is general information about the effectiveness of the known ingredients contained in the product Comfrey Herbal Ointment. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Comfrey Herbal Ointment. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Beeswax has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used orally as a medicinal agent (11)....when used topically (11,55245,96328,96329).
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of medicinal amounts of beeswax during pregnancy and lactation.
POSSIBLY SAFE ...when used topically for less than 6 weeks on unbroken skin at a daily dose providing no more than 100 mcg of pyrrolizidine alkaloid (PA) constituents. PAs are absorbed through the skin (11990,44898,44902,92568).
POSSIBLY UNSAFE ...when used for extended durations or in high concentrations on unbroken skin. Topically, hepatotoxic pyrrolizidine alkaloids (PAs) in comfrey can be absorbed in quantities sufficient to cause toxicity with extended use for greater than 6 weeks or in quantities providing more than 100 mcg of PAs (11990,92568). ...when used topically on broken skin. PAs can be absorbed through broken skin. In countries where the PA content of comfrey is not regulated, including Australia and the United States, creams containing comfrey are required to include a warning not to use on broken skin (44950,44951).
LIKELY UNSAFE ...when used orally because of its potential for acute or chronic liver toxicity. Comfrey contains hepatotoxic pyrrolizidine alkaloids (PAs). Chronic ingestion of more than 1 mg daily for 2 weeks or more than 100 mcg daily for longer durations can cause liver disease. PAs may also be carcinogenic (11987,99068). The FDA has recommended removal of oral comfrey products from the market (11988).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically.
In addition to hepatotoxicity and possible carcinogenicity, the pyrrolizidine alkaloids (PAs) in comfrey might be teratogenic. PAs are absorbed through the skin (11987,11988,11990).
LIKELY SAFE ...when olive fruit is used orally and appropriately in amounts commonly found in foods.
POSSIBLY SAFE ...when olive leaf extract is used orally and appropriately. Olive leaf extract providing 51-100 mg oleuropein daily has been used with apparent safety for 6-8 weeks (92245,92247,101860). There is insufficient reliable information available about the safety of olive fruit extract when used in amounts greater than those found in foods.
PREGNANCY AND LACTATION:
Insufficient reliable information available; stick with amounts commonly found in foods.
LIKELY SAFE ...when used orally in amounts commonly found in foods. ...when used topically and appropriately. Health Canada considers soybean oil to be a safe alternative to low-dose DEET products when used topically as a mosquito repellent (13083,93685). There is insufficient reliable information available about the safety of soybean oil when used orally in medicinal amounts.
PREGNANCY: LIKELY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about soybean oil when used orally in medicinal amounts; avoid using in amounts greater than those typically found in foods.
LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about soybean oil when used orally in medicinal amounts; avoid using in amounts greater than those typically found in foods.
Below is general information about the interactions of the known ingredients contained in the product Comfrey Herbal Ointment. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, CYP3A4 inducers might increase the risk of adverse effects from the pyrrolizidine alkaloid constituents in comfrey.
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Theoretically, comfrey might have additive adverse effects on the liver when used with hepatotoxic drugs.
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Below is general information about the adverse effects of the known ingredients contained in the product Comfrey Herbal Ointment. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, beeswax is well tolerated.
Allergic reactions to beeswax are possible in some patients (11).
Topically, beeswax may cause allergic contact dermatitis. In most cases, this reaction is likely caused by the propolis component of beeswax (55245,102517).
Dermatologic ...Topically, beeswax may cause allergic contact dermatitis. In most cases, this reaction is likely caused by the propolis component of beeswax (55245,102517). While this reaction is thought to be rare in the general population, one cross-sectional study found that 18% of patients with a history of cheilitis or facial dermatitis experienced positive reactions to beeswax. While most of these patients also had a positive reaction to a propolis patch test, some did not, suggesting that a substance in beeswax itself may be involved in this sensitization (102517).
Immunologic ...Orally, beeswax may cause allergic reactions (11). Topically, beeswax may cause allergic contact dermatitis. In most cases, this reaction is likely caused by the propolis component of beeswax (102517).
General
...When used orally, comfrey may be unsafe.
Topically, comfrey is generally well tolerated when applied to intact skin.
Most Common Adverse Effects:
Topically: Eczema, erythema, irritation, itching, rash.
Serious Adverse Effects (Rare):
All ROAs: Ascites, cirrhosis, death, hepatic fibrosis, hepatomegaly, pulmonary hypertension, and sinusoidal obstruction syndrome. These adverse effects are likely related to the pyrrolizidine alkaloid constituents of comfrey.
Dermatologic ...Topically, comfrey-containing creams and ointments may cause skin redness, irritation, itching, rash, and eczema (44902,44912,44917,44919,92566,92570,92571).
Hepatic ...The pyrrolizidine alkaloid constituents of comfrey can cause acute sinusoidal obstruction syndrome characterized by sudden abdominal pain, vomiting, ascites, and hepatomegaly. In subacute disease, comfrey can cause ascites, hepatomegaly, abdominal pain, diarrhea, vomiting, and abdominal swelling. Chronic toxicity appears as asthenia and progressive ascites. Hepatic fibrosis and inflammation may resolve, but hepatic failure is common with more severe disease. This may occur as late as 2 years after the initial ingestion. Other signs and symptoms of pyrrolizidine toxicity include bile duct proliferation, fatty changes of the liver, fibrosis, cirrhosis, and vascular lesions (11988). The mortality associated with comfrey toxicity is 50%. However, specific toxic levels seem to vary among individuals (11990).
Pulmonary/Respiratory ...The pyrrolizidine alkaloid constituents of comfrey can damage the lungs, resulting in pulmonary hypertension (11987,11988,11990). A case report involving a 66-year-old female with known arterial hypertension, mild kidney insufficiency, and type 2 diabetes described severe partial respiratory insufficiency and pulmonary hypertension. The patient admitted to using a number of alternative therapies daily, including comfrey (44911).
Other ...Comfrey contains toxic pyrrolizidine alkaloids, which are carcinogenic and mutagenic (12841,12842).
General
...Orally, olive fruit is well tolerated when used in typical food amounts.
Olive leaf extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache and stomach discomfort.
Dermatologic ...Orally, one patient in one clinical trial reported bad skin and acne after using olive leaf extract (101860).
Gastrointestinal ...Orally, three patients in one clinical trial reported stomach ache after using olive leaf extract (101860).
Neurologic/CNS ...Orally, three patients in one clinical trial reported headache after using olive leaf extract (101860).
Psychiatric ...In one case report, a 67-year-old female experienced irritability, anger, a lack of control, and feelings of sadness and negativity after consuming a multi-ingredient product containing olive leaf extract 5 grams, horseradish root, and eyebright daily for 38 days. All psychiatric symptoms disappeared within days of stopping the combined product. It is hypothesized that the hydroxytyrosol component of olive leaf extract contributed to these symptoms due to its chemical similarity to dopamine; however, it is not clear if these symptoms were due to the olive leaf extract or to the other ingredients (96245).
Pulmonary/Respiratory ...Olive tree pollen can cause seasonal respiratory allergy (1543).
General ...Orally, soybean oil seems to be generally well tolerated. No adverse effects have been reported in clinical trials in adults eating foods enriched with soybean oil or taking supplements containing soybean oil unsaponifiable fractions (10693,10694,33238,33257,93110,93111). Soybean oil can cause an allergic reaction in sensitive individuals (4079,4080,93683).
Immunologic ...Soybean oil can cause an allergic reaction in individuals allergic to the Fabaceae/Leguminosea family. Members of this family include peanuts, soybeans, and others (4079,4080). The inclusion of soybean oil as an inactive ingredient in a generic formulation of the drug omeprazole caused anaphylaxis in two females with soybean allergies (93683).
