Panoderm I by American Biologics

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Although there has been interest in using oral shark liver oil for cancer, there is insufficient reliable information about the clinical effects of shark liver oil for this purpose.
• Chemotherapy-induced leukopenia. Although there has been interest in using oral shark liver oil for chemotherapy-induced leukopenia, there is insufficient reliable information about the clinical effects of shark liver oil for this purpose.
• Common cold. Although there has been interest in using oral shark liver oil for the common cold, there is insufficient reliable information about the clinical effects of shark liver oil for this purpose.
• Influenza. Although there has been interest in using oral shark liver oil for influenza, there is insufficient reliable information about the clinical effects of shark liver oil for this purpose.
• Radiation-induced nausea and vomiting. Although there has been interest in using oral shark liver oil for radiation-induced nausea and vomiting, along with other adverse effects of radiation therapy, there is insufficient reliable information about the clinical effects of shark liver oil for this purpose.
• Wound healing. Although there has been interest in using topical shark liver oil for wound healing, there is insufficient reliable information about the clinical effects of shark liver oil for this purpose. More evidence is needed to rate shark liver oil for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related macular degeneration (AMD). Preliminary clinical research shows that weekly intravenous infusions of squalamine lactate 25 or 50 mg/m² for 4 weeks improves visual acuity compared with baseline in 26% of patients with choroidal neovascularization or "wet" AMD (96042).
• Lung cancer. Preliminary clinical research shows that squalamine, given intravenously along with carboplatin and paclitaxel, results in objective tumor response in 23% to 28% of patients with advanced non-small cell lung cancer. A dosing regimen consisting of squalamine 100-400 mg/m² daily given as a 5-day continuous infusion, with paclitaxel and carboplatin given on day 1, repeated once every 3 weeks for 6 cycles, seems to be more effective than weekly doses of squalamine 100-200 mg/m² along with weekly doses of paclitaxel and carboplatin for 12 weeks. The one-year survival rate is 40% with the 5-day infusion. However, the weekly dosing regimen appears to be better tolerated (96043,96045).
• Retinal vein occlusion. Preliminary clinical research shows that adjuvant treatment with eye drops containing squalamine lactate (OHR-102, Ohr Pharmaceuticals) 0.2% twice daily for 38 weeks along with intravitreal ranibizumab as needed every 4 weeks moderately improves best-corrected visual acuity compared to ranibizumab alone in patients with macular edema due to retinal vein occlusion. However, concomitant use of squalamine does not appear to delay the time until recurrent edema or reduce the need for ranibizumab injections (96044).
• Tinea capitis (scalp ringworm). Preliminary clinical research shows that topical application of squalamine 1% lotion once daily for 3 weeks does not cure scalp ringworm, or improve the size of scalp lesions, in boys aged 6-15 years with scalp ringworm. However, squalamine appears to increases hair growth nearly two-fold compared with a placebo ointment (96041). More evidence is needed to rate squalamine for these uses.

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POSSIBLY SAFE ...when used orally and appropriately, short-term. Shark liver oil 1.5 grams once daily has been used safely for 8 weeks (94286).

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

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POSSIBLY SAFE ...when used topically and appropriately. Squalamine eye drops have been safely used twice daily for up to 38 weeks (96044). ...when used intravenously and appropriately. Squalamine has been safely used at a dose of up to 50 mg/m2once weekly for up to 4 weeks, or 300 mg/m2 daily as a 5-day infusion once every 3 weeks for up to 6 cycles (96040,96042,96045). There is insufficient reliable information available about the safety of squalamine when used orally.

CHILDREN: POSSIBLY SAFE
when used topically and appropriately, short-term. Squalamine 1% lotion has been safely applied to the scalp once daily for up to 3 weeks in children aged 6-15 years (96041).

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

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General ...Orally, shark liver oil seems to be well tolerated.

Cardiovascular ...Orally, shark liver oil 15 grams daily for 4 weeks has been shown to increase levels of total cholesterol by about 41. 5 mg/dL to borderline high, and decrease levels of high-density lipoprotein (HDL) cholesterol, in healthy adults. These changes in lipid levels normalized after discontinuation of shark liver oil (94284). Lower doses of shark liver oil, 1.5 grams daily for 8 weeks, do not appear to significantly affect total cholesterol, low-density lipoprotein (LDL) cholesterol, HDL cholesterol or triglyceride levels in healthy patients (94286).

Gastrointestinal ...Orally, shark liver oil has been reported to cause gastrointestinal side effects in one clinical study when taken in doses of 1. 5 grams daily; however, these side effects did not occur more frequently than with placebo (94286).

Hepatic ...Orally, a case of severe acute hepatitis probably related to use of shark liver oil twice daily for 2 weeks has been reported. The patient presented with abdominal discomfort, jaundice, malaise, pruritus, and elevated levels of bilirubin and liver enzymes. Other potential causes were ruled out (94285).

Pulmonary/Respiratory ...Both shark liver oil and the constituent squalene have been associated with cases of aspiration and subsequent lipoid pneumonia (2546,2547,2548).

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General ...Topically, squalamine seems to be well tolerated (96041,96044). No adverse effects have been reported. However, a thorough evaluation of safety outcomes related to topical use has not been conducted.
Intravenously, squalamine also seems to be well tolerated (96040,96042,96045). Possible adverse effects include nausea, vomiting, mild loss of appetite, transient elevation of liver markers, myalgias and muscle cramps, and fatigue (96040).

Gastrointestinal ...Intravenously, squalamine has been associated with reports of mild to moderate nausea and vomiting, as well as mild loss of appetite, in clinical research (96040).

Hepatic ...Intravenously, squalamine at doses above 192 mg/m2 daily has been associated with reports of elevated hepatic transaminase levels. Levels of aspartate aminotransferase and alanine aminotransferase were about 5 to over 20 times above upper normal levels in some patients. The increased levels were noted 2-5 days after beginning squalamine. Both values returned to baseline within 6-23 days. These patients also had mildly elevated alkaline phosphatase and lactate dehydrogenase and one patient had a moderately elevated bilirubin level (96040).

Musculoskeletal ...Intravenously, squalamine has been associated with reports of mild to moderate myalgias and muscle cramps in clinical research (96040).

Neurologic/CNS ...Intravenously, squalamine has been associated with reports of mild to moderate fatigue in clinical research (96040).

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