Celandine Non-Alcohol [Discontinued] by Hawaii Pharm

POSSIBLY EFFECTIVE

• Dyspepsia. A specific combination product containing greater celandine (Iberogast, Medical Futures, Inc) seems to improve symptoms of dyspepsia. The combination includes greater celandine plus peppermint leaf, German chamomile, caraway, licorice, clown's mustard plant, lemon balm, angelica, and milk thistle (7049,12724). A meta-analysis of studies using this combination product suggests that taking 1 mL orally three times daily over a period of 4-weeks significantly reduces severity of acid reflux, epigastric pain, cramping, nausea and vomiting compared to placebo (13089).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Preliminary clinical research suggests that injecting a specific semi-synthetic derivative of the greater celandine constituent chelidonine (Ukrain; not available in North America) intravenously helps improve survival of some patients with colorectal, bladder, pancreatic, lung, or breast cancer. However, poor study design makes it difficult to draw conclusions about the efficacy of Ukrain for cancer (13409,53460,53472,53473,53497,53498). Also, some researchers suggest that doses sufficiently high to shrink tumors might be too toxic for clinical use (13412). In addition to assessing Ukrain, some research has assessed the effects of a greater celandine decoction in cancer patients. Some preliminary clinical research suggests that taking 30 mL of an oral solution containing greater celandine twice daily for 2 weeks might have antitumor effects in patients with esophageal squamous cell carcinoma. Each dose of solution was equivalent to 30 grams of rough herbs (53512). More evidence is needed to rate greater celandine for these uses.

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POSSIBLY UNSAFE ...when used orally. Greater celandine has been implicated in dozens of cases of liver damage, primarily in European countries including Germany (363,13410,16839,41412,53502,53504,53506,53507,53510). There is insufficient reliable information available about the safety of greater celandine when used topically or when derivatives of greater celandine constituents are used intravenously.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Research in vitro shows that chelidonine, a constituent of greater celandine, inhibits cytochrome P450 2D6 (CYP2D6) enzyme activity (99455). Theoretically, greater celandine might increase levels of drugs metabolized by CYP2D6.  Details Some drugs metabolized by CYP2D6 include amitriptyline (Elavil), clozapine (Clozaril), codeine, desipramine (Norpramin), donepezil (Aricept), fentanyl (Duragesic), flecainide (Tambocor), fluoxetine (Prozac), meperidine (Demerol), methadone (Dolophine), metoprolol (Lopressor, Toprol XL), olanzapine (Zyprexa), ondansetron (Zofran), tramadol (Ultram), trazodone (Desyrel), and many others.

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General ...Orally, greater celandine has been implicated in dozens of cases of liver damage (363,13410,16839,41412,53502,53504,53506,53507,53510). Greater celandine can also cause rash (13410). Greater celandine extract has caused a single case of hemolytic anemia (53508).
Topically, greater celandine can cause contact dermatitis (13411).
Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause gastrointestinal symptoms, increased body temperature, general burning sensations, and bleeding (13409,53460).

Dermatologic ...Orally, greater celandine can cause rash (13410). Topically, greater celandine can cause contact dermatitis (13411).

Gastrointestinal ...Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause gastrointestinal symptoms, including obstipation, nausea, and diarrhea (13409,53460).

Hematologic ...Orally, greater celandine extract has caused a single case of hemolytic anemia. This resulted in thrombocytopenia, destruction of liver cells, and kidney failure, requiring treatment (53508).
Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause bleeding (13409,53460).

Hepatic ...Orally, greater celandine has been implicated in dozens of cases of liver damage (363,13410,16839,41412,53502,53504,53506,53507,53510). The cause is unknown, but appears to be idiopathic. It seems to be independent of dose, and the amount of time before development of liver disease is generally long and variable (363,53506). The main symptom is usually jaundice (53506). Liver enzymes are elevated at least two-fold in all cases where measurements were completed (53506). Although other causes of liver toxicity cannot be ruled out in some cases, many reported cases of hepatotoxicity are probably or likely associated with the use of greater celandine. Recurrence of hepatitis with unintentional re-exposure has also been reported (53506,94282). Discontinuation of greater celandine usually results in a fairly rapid recovery although liver enzymes need months to return to normal (53506,94282). Death has occurred in one patient with hepatitis due to bleeding associated with colonic diverticulitis. Causality was described as possible, not probable, in this case (53506).

Neurologic/CNS ...Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause increased body temperature and general burning sensations (13409).

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