Alkanet Non-Alcohol [Discontinued] by Hawaii Pharm

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Burns. Preliminary clinical research in adults and children with second degree burns shows that applying a dressing containing olive oil, natural beeswax, and alkanna root extract to burn wounds once daily, usually starting within 24 hours of injury, improves healing compared with applying a dressing containing nitrofurazone and rifamycin every two days. Skin epithelization was initiated approximately 4 days earlier and mean hospital stay was about 6 days shorter for patients treated with the alkanna dressing compared with the control dressing. Pain was also reduced by approximately 14% (96328). The validity of these results is limited by a lack of appropriate randomization and blinding, which introduces the potential for bias.
• Wound healing. Clinical research shows that applying alkanna root extract 20% ointment to the donor site after removal of a skin graft improves wound healing compared with applying base ointment alone. At 4 weeks, approximately 97% of patents using the alkanna ointment had complete healing compared with about 23% of patients using base ointment alone (99905). It is unclear if the alkanna ointment reduces pain or scarring at the site of skin graft removal compared to base ointment alone. More evidence is needed to rate alkanna for these uses.

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LIKELY UNSAFE ...when products containing hepatotoxic pyrrolizidine alkaloid (PA) constituents are used orally. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Tell patients not to use alkanna preparations that are not certified and labeled as hepatotoxic PA-free. ...when products containing hepatotoxic PAs are used topically on abraded or broken skin. Absorption of hepatotoxic PAs through broken skin can lead to systemic toxicities (12841). Tell patients not to use topical alkanna preparations that are not certified and labeled as hepatotoxic PA-free. There is insufficient reliable information available about the safety of PA-free alkanna when used orally or topically on unbroken skin.

PREGNANCY AND LACTATION: LIKELY UNSAFE
when alkanna preparations containing hepatotoxic pyrrolizidine alkaloids (PAs) are used orally. PAs might be teratogenic and hepatotoxic (12841,12842). There is insufficient reliable information available about the safety of alkanna products that do not contain hepatotoxic PAs when used during pregnancy and lactation; avoid using.

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General ...Orally, the major concern with alkanna is its pyrrolizidine alkaloid (PA) content. These constituents are hepatotoxic, pneumotoxic, carcinogenic, and mutagenic (12841,12842). Chronic exposure to other plants containing hepatotoxic PA constituents is associated with veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842).
Topically, PAs can be absorbed through the broken skin. Absorption of PAs can lead to systemic toxicities (12841).
There is currently a limited amount of information available about the adverse effects of PA-free alkanna.

Hepatic ...Orally and topically, alkanna might cause toxicity. The major concern with alkanna use is its hepatotoxic pyrrolizidine alkaloid (PA) content (12841,12842). Chronic exposure to other plants containing hepatotoxic PA constituents is associated with veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842).

Oncologic ...Orally and topically, alkanna might cause toxicity. The major concern with alkanna is its pyrrolizidine alkaloid (PA) content. These constituents are carcinogenic and mutagenic (12841,12842).

Pulmonary/Respiratory ...Orally and topically, alkanna might cause toxicity. The major concern with alkanna use is its pyrrolizidine alkaloid (PA) content. These constituents are pneumotoxic (12841,12842).

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