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Mesoglycan

Common Name(s): Aortic glycosaminoglycan, GAG, Glycosaminoglycan, Mesoglycan, Mesoglycan sodium, Prisma

Medically reviewed by Drugs.com. Last updated on May 1, 2019.

Clinical Overview

Use

Mesoglycan is approved in many European countries for the treatment of blood vessel homeostasis diseases. Mesoglycan has demonstrated efficacy in various conditions with vascular etiologies and/or manifestations, including diabetic retinopathy, ischemic stroke, deep vein thrombosis (DVT), venous ulcers, telangiectasias, Raynaud phenomenon, cerebrospinal-venous insufficiency, peripheral arterial disease, and mechanical edema caused by traumatic disease. Additionally, long-term administration of mesoglycan has been shown to improve insulin sensitivity in patients with metabolic syndrome.

Dosing

Oral: The usual dose of mesoglycan is 100 mg daily (given either once daily or in 2 divided doses of 50 mg), often as add-on therapy, for conditions with vascular etiologies and/or manifestations. Duration of therapy has ranged from 2 weeks to 3 years.

In one study, mesoglycan 60 mg/day orally was administered for 20 days in patients with peripheral obstructive arterial disease.

Intramuscular: Initial dosing with intramuscular (IM) mesoglycan (30 to 60 mg daily for up to 3 weeks; or a single dose of 60 mg) with or without continuation of an oral dosage of 100 mg/day for up to 18 months has been used in clinical trials in patients with chronic venous ulcers, ischemic stroke, or metabolic syndrome.

Contraindications

Contraindications have not been identified.

Pregnancy/Lactation

Avoid use. Information regarding safety and efficacy in pregnancy and lactation is lacking.

Interactions

None well documented.

Adverse Reactions

Mesoglycan is well tolerated.

Toxicology

No data.

Source

Mesoglycan is a sulfated polysaccharide extract usually obtained from porcine intestinal mucosa but sometimes from calf/beef aorta (ie, aortic glycosaminoglycan). It is composed of heparin sulfate (typically 52%), dermatan sulfate (35%), electrophoretically slow moving heparin (8%), and chondroitin sulfate (5%).Lee 2016, Tufano 2010, Varatharajan 2016 Vascular glycosaminoglycans are essential components of the endothelium and vessel wall.Tufano 2010

History

Aortic glycosaminoglycans and mucopolysaccharides (ie, mesoglycan) are authorized drugs in many European countries and, historically, have been used to treat a variety of diseases of blood vessel homeostasis.Lee 2016 Mesoglycan, a glycosaminoglycan compound, is available as a parenteral and oral formulation.Valvano 2015 Its mechanism of action as an antithrombotic and profibrinolytic is being studied.Andreozzi 2007, Lee 2016, Ryu 2011

Chemistry

Mesoglycan is a polysaccharide complex rich in sulfur radicals. It is reported to have several favorable actions on the fibrinolytic system and macrorheologic and microrheologic parameters, to restore the electronegativity of the vascular endothelium,Viliani 2009 to reduce capillary permeability, and to inhibit neutrophil adhesion and activation.Varatharajan 2016 Like the natural glycosaminoglycan heparin, heparan sulfate proteoglycan, one of the components of mesoglycan, has been reported to inhibit vascular smooth muscle cells in vitro, suggesting benefit in proliferative disorders such as atherosclerosis and cancer.Lee 2016 Heparin and dermatan sulfate are thrombin inhibitors that act through complementary pathways (ie, antithrombin and heparin cofactor II, respectively). Activated factor X is also inhibited by heparan sulfate.Tufano 2010

Endothelium-mediated activities include platelet adhesion, lipoprotein lipase stimulation, inhibition of smooth muscle cell proliferation, activation of antithrombin III and heparinic cofactor II, and tissue plasminogen activator stimulation.Andreozzi 2007

Uses and Pharmacology

Mesoglycan is an antithrombotic and profibrinolytic. Its components, heparin and dermatan sulfate, are thrombin inhibitors that act through complementary pathways. Inhibition of neutrophil adhesion and activation, decreased capillary permeability, and enhanced systemic fibrinolysis have been demonstrated in a clinical trial (2001).Arosio 2001 More recent studies reveal that mesoglycan reduces proliferation of vascular smooth muscle cells, a critical component of atherosclerosis and tumor development, through nonapoptotic processes. In vitro studies support G0/G1 cell cycle growth suppression via activation of adenosine monophosphate–activated protein kinase (AMPK) that mediates cell cycle regulation and inhibits protein synthesis. Mesoglycan has been shown to induce the expression of the protein p53 (a key regulator of the cell cycle) and p21 (a downstream target of p53); cell cycle arrest appears to be via AMPK-dependent phosphorylation of p53 in human vascular smooth muscle cells. Additionally, mesoglycan may inhibit mammalian target of rapamycin (mTOR) signaling via AMPK activation, which could be responsible for the antiproliferative effect of mesoglycan in vascular smooth muscle cells.Andreozzi 2007, Lee 2016 Mesoglycan has also been shown to inhibit production of endothelial microparticles (EMPs) in vitro under uremic conditions. EMPs tend to reflect cellular injury, are elevated in many vascular diseases, and are thought to play a direct role in thrombogenesis.Ryu 2011

Diabetes/Metabolic syndrome

Clinical data

An Italian 6-month, placebo-controlled, observational study in 68 adult patients with diabetic retinopathy investigated the effects of mesoglycan on the pathology of this microcirculatory disorder. The average age of participants was approximately 60 years, and approximately half (51%) had disease duration of more than 10 years. Overall, diabetic retinopathy was confirmed in 85% (115) of eyes and contrast sensitivity was altered in 75%. Results data supported a benefit of controlled-release mesoglycan 100 mg/day for 6 months compared with placebo. Compared with baseline, the number of eyes with impaired visual acuity and impaired visual field decreased with mesoglycan from 58 to 14 and from 52 to 6, respectively. The placebo group experienced either no improvement or worsening. The difference between the groups was significant for both visual acuity (P=0.0012) and visual field (P=0.0001) measurements. Contrast sensitivity, originally impaired in 79% (54) of eyes in the placebo group and 43% (29) in the treatment group, did not improve with placebo but persisted in only 10% (7) of eyes treated with mesoglycan at study end. Overall, a significant reduction from baseline in microhemorrhages (70% to 27%), microaneurysms (67% to 33%), and hard exudates (80% to 0%) was documented. No adverse effects were reported.Pacella 2012

A randomized, double-blind, placebo-controlled trial investigated the acute and chronic effects of mesoglycan on endothelial function and arterial elastic properties, as well as on insulin sensitivity in 30 patients with metabolic syndrome. Significant improvements in endothelial function (as measured by flow-mediated dilation [FMD]) and arterial elasticity (ie, improved distensibility, compliance, stiffness) were observed after administration of a single dose of mesoglycan 60 mg intramuscularly (IM), followed by long-term oral administration of 50 mg twice daily for 3 months compared with baseline and placebo. Mesoglycan-treated patients exhibited near normalization of depressed endothelial function. Additionally, insulin sensitivity (ie, fasting glucose, insulin and homeostatic assessment model algorithm [HOMA] index) improved with long-term mesoglycan treatment. The significant predictive factor of vascular improvement was the HOMA index (P=0.02). Mild dyspepsia was reported by 4 patients taking mesoglycan and 2 taking placebo.Valvano 2015

Ischemic stroke

Clinical data

Data from a 2010 review of studies investigating mesoglycan for vascular diseases suggest a role for mesoglycan in treatment of arterial disease (ie, atherosclerotic, hypertensive, diabetic arterial disease), primarily in the initial stages of disease when reduced arterial wall elasticity is one of the functional impairments. Four small studies (3 prospective, 1 randomized controlled published between 1988 and 2002), ranging in size from 20 to 46 patients and investigating mesoglycan in patients with a recent history of ischemic stroke or transient ischemic attack (TIA) and increased plasma fibrinogen levels (a risk factor for ischemic stroke and myocardial infarction) were identified. In 2 of the prospective studies and the 1 randomized controlled trial, mesoglycan was administered at 50 mg orally twice daily for 2 months to more than 3 months; in the other prospective study, mesoglycan was administered at 30 mg IM twice daily for 15 days. Mesoglycan was effective in reducing plasma fibrinogen levels without interfering with other coagulative parameters. In one of the studies that also evaluated the effects of mesoglycan in chronic cerebrovascular disease, decreases in neurologic deficits were observed. Additionally, in a large multicenter clinical trial (N=1,398), mesoglycan (30 mg twice daily IM for 2 weeks, then 100 mg daily orally; median therapy duration, 18 months) was as effective as aspirin (300 mg daily) in preventing vascular events after cerebral ischemic events in patients with a history of atherothrombotic stroke, TIA, reversible ischemic neurological deficit, or minor stroke; more adverse effects were reported in the aspirin group than the mesoglycan group.Tufano 2010 A small 2002 study (N=46) compared mesoglycan 50 mg twice daily to ticlopidine 250 mg twice daily in patients with previous ischemic stroke and found similar, though slightly less consistent, reductions in plasma fibrinogen levels in both treatment groups.Orefice 2002

Peripheral arterial disease

Clinical data

The effects of 2 months of mesoglycan as add-on therapy were investigated in 540 adults (mean age, 70.9 years) with lower-extremity peripheral arterial disease in a prospective, nonrandomized, noncontrolled, open-label study. Mesoglycan 50 mg twice daily was administered for two 60-day treatment cycles separated by a 60-day washout period. Most patients had more than one risk factor; the prevalence of hypertension and smoking was high, as was that of dyslipidemia, diabetes, and organ insufficiency or failure. Prior medication regimens were not changed during the study. After 6 months (4 months total of mesoglycan therapy), mean brachial artery FMD increased significantly by 15.7% (P<0.001). FMD increased continuously during the first mesoglycan cycle, stabilized during the washout period, and increased again in the majority of patients (84%) during the second treatment cycle. Baseline data were different according to risk factor group (ie, hypertension, dyslipidemia, diabetes, smoker). FMD changes were higher for the youngest patients and for females, and were lowest for hypertensive patients and smokers. Intimal media thickness and walking distance also improved significantly, by 0.05 mm and approximately 47 m, respectively (P<0.001 each). Mesoglycan treatment resulted in an improvement in patient condition by 71.6% according to investigator assessment and by 64.5% according to patient assessment. Mesoglycan was well tolerated.Gossetti 2015 In a 2010 review of studies suggesting a role for mesoglycan in treatment of arterial disease, improvements in cell wall responsiveness, signs and symptoms, and walking capacity were noted in patients with peripheral obstructive arterial disease in 2 small prospective studies (N=10 and N=36) published in 1987 and 1997, respectively, and one larger double-blind, randomized controlled trial (N=242) from 2001. Doses ranged from 60 to 100 mg daily for 20 days to up to 1 year.Tufano 2010

Raynaud phenomenon

Clinical data

In an observational study (case series), adult patients with primary or secondary refractory Raynaud phenomenon (N=25) received mesoglycan 50 mg as add-on therapy twice daily for 12 months. Treatments used prior to add-on therapy and allowed during the study included calcium channel blockers, prostanoids, angiotensin receptor blockers, angiotensin-converting enzyme (ACE) inhibitors, methylprednisolone, methotrexate, cyclosporine, and simvastatin. At the 12-month follow up, a significant and consistent improvement in nailfold video capillaroscopy was documented in 83% of patients and more than half of the total group (P<0.0001). Prevalence of daily attacks decreased from 80% at baseline to 28% at 6 months and 13% at 12 months of mesoglycan therapy. Additionally, a significant decrease was observed in average monthly frequency of attacks compared with baseline, with a 41% decrease at 6 months and 74% decrease at 12 months (P<0.0001). Of the 24 patients who completed 1 year of mesoglycan add-on therapy, 2 became attack free.Di Biase 2013

Telangiectasias

Clinical data

A retrospective observational study in women assessed the effects of a multitherapy protocol that included mesoglycan on the anatomopathologic and pathophysiologic aspects of telangiectases. The study used the following treatment regimen: Initially, reflux was eliminated from type A telangiectasias associated with saphenous vein reflux and followed after 3 weeks by sclerotherapy with internal and external compression of type B telangiectasias; this was followed after 3 months by dermal stimulation with intradermal injections of mesoglycan (Prisma) to stimulate collagen around type C telangiectasias. Patients continued treatment with oral mesoglycan 100 mg/day for 3 weeks. A statistically significant difference was shown for the multitherapy approach for both clinical examination (P=0.0002) and photographic analysis (P<0.0001).Ferrara 2013

Venous insufficiency

Cerebrospinal venous insufficiency

Clinical data

Mesoglycan 100 mg/day has been used safely as add-on therapy to standard immunomodulatory or immunosuppressive therapies for up to 12 months in patients with multiple sclerosis undergoing endovascular treatment for cerebrospinal venous insufficiency to help normalize coagulation activation and endothelial dysfunction. In a prospective observational study (N=110), more than half of patients (55%) experienced a favorable outcome within 1 month after endovascular treatment, 25% regressed in the following 3 months, and 25% did not experience benefit. No analysis of the potential effect of mesoglycan was conducted.Napolitano 2014

Chronic venous insufficiency

Clinical data

The effect of add-on mesoglycan to standard care on cutaneous blood flow was investigated in 75 women with chronic venous disorders. Women were divided into 4 groups based on disease severity (CEAP classification [C1, C2, C3, or C4]); the treatment group received mesoglycan 50 mg twice daily for 90 days plus standard care (ie, exercise, leg elevation, weight loss, blood pressure control, compression stockings), while the control group received only standard care. After 90 days of treatment, improvement in mean peak flow, measured by laser Doppler flowmetry, was observed in all 37 women receiving mesoglycan (about 14% to 20% increase from baseline). The control group showed no change. Patients with CEAP C1 classification (mild disease) experienced a dilation of skin microvasculature increase of +18.2 perfusion units compared with a decrease of −3.6 perfusion units in CEAP C1 controls (P=0.027). Significant improvement was also seen by clustering CEAP C1 and C2 groups, with a trend towards benefit in CEAP C3 and C4 groups.Maresca 2015

A large (N=1,066) study of the impact of mesoglycan treatment on quality of life in patients with chronic venous disease noted improvements in subjective quality-of-life scores and objective measures such as edema.Allegra 2014

Deep vein thrombosis

Clinical data

A retrospective analysis evaluated the effects of mesoglycan therapy in 265 cases (from 1988 to 1997) of previous DVT and chronic venous insufficiency. After 3 or 6 months of anticoagulant therapy, mesoglycan 100 mg/day was administered with compression stockings for 3 years to patients with primary (n=56) or recurrent (n=27) DVT. The prevalence of postthrombotic syndrome during the treatment period was significantly lower compared to the previous thrombotic episode (P<0.0004). Additionally, mesoglycan was effective in patients with chronic venous insufficiency; all chronic venous dysfunction scores (ie, disability, pain, edema) were improved during the 3-year follow-up period.Andreozzi 2007

Mechanical edema

Clinical data

The effectiveness of mesoglycan in managing mechanical edema was investigated in a prospective, randomized, open-label study conducted in 44 adult patients with unilateral lower-limb edema caused by traumatic disease of the lower limb, fracture, total hip or knee replacement, immobilization, or plantar weight disorders. Compared with patients receiving physiotherapy alone, self-reported pain and lymphedema symptoms were significantly improved with mesoglycan 50 mg twice daily plus physiotherapy at the 1-month follow-up (P<0.0001). Objective measurements of the malleolus and calf circumferences also significantly decreased compared with physiotherapy alone (mean reductions of 3.1 cm vs 1 cm and 1.6 cm vs 0.3 cm, respectively [P<0.0001 each]). However, tibia-tarsal movement parameters did not change significantly. Results did not change when evaluated in the intention-to-treat (ITT) population. Mesoglycan was well tolerated, with only one adverse event reported but not confirmed to be related to therapy.Viliani 2009

Venous ulcers

Clinical data

In a double-blind, multicenter Italian study (N=183), ambulatory adult patients with a history and current clinical diagnosis of chronic venous insufficiency, plus the presence of a leg ulcer (maximum diameter, 4 to 20 cm2), were randomized to receive mesoglycan or placebo. Mesoglycan was initiated at 30 mg IM once daily for 3 weeks and followed by 50 mg orally twice daily until complete target ulcer healing or the final scheduled visit (24 weeks ± 1 week). All patients received compression therapy and topical wound care (ie, saline cleansing, local antiseptics). By study end, the estimated rate of healing was significantly better for mesoglycan (97%) versus placebo (82%) (P<0.05); differences were still significant after adjusting for baseline ulcer area. The corresponding relative risk for healing was 1.48 (95% confidence interval [CI], 1.05 to 2.09) at study end and was 1.43 (95% CI, 1.01 to 2.04) after baseline adjustment. The estimated time to heal 75% of patients was 90 days with mesoglycan versus 136 days with placebo. Complete healing of a concomitant ulcer was achieved in 7 of 10 mesoglycan-treated patients and 1 of 5 patients receiving placebo.Arosio 2001 Systematic reviews (2011 and 2016) of available evidence regarding clinical benefit of adjunctive treatments for chronic venous ulcers identified one study that investigated systemic mesoglycan. The evidence was considered to be of moderate quality.Nelson 2011, Varatharajan 2016 Data from a randomized controlled trial (N=40) evaluating the effects of topically applied mesoglycan compared with a plant-based extract on healing rates of chronic venous ulcers were of low quality and inconclusive.Nelson 2011

Other uses

Mesoglycan has been evaluated in small studies for treatment of cutaneous necrotizing venulitis, chronic vascular encephalopathy, and cerebrovascular ischemia, with some beneficial effects noted.Lotti 1993, Mansi 1988, Orlandi 1991, Vecchio 1993

Dosing

Oral

The usual dose of mesoglycan is 100 mg daily (given either once daily or in 2 divided doses of 50 mg), often as add-on therapy, for conditions with vascular etiologies and/or manifestations (eg, chronic venous insufficiency, cerebrospinal venous insufficiency, diabetic retinopathy, deep vein thrombosis, ischemic stroke, mechanical edema caused by traumatic injury, peripheral arterial disease of the lower extremity, Raynaud phenomenon, metabolic syndrome, telangiectasias). Duration of therapy has ranged from 2 weeks to 3 years.Andreozzi 2007, Di Biase 2013, Ferrara 2013, Gossetti 2015, Maresca 2015, Napolitano 2014, Pacella 2012, Tufano 2010, Valvano 2015, Viliani 2009

In one study, mesoglycan 60 mg/day orally was administered for 20 days in patients with peripheral obstructive arterial disease.Tufano 2010

IM

Initial dosing with IM mesoglycan (30 to 60 mg daily for up to 3 weeks; or a single dose of 60 mg) with or without continuation of an oral dosage of 100 mg/day for up to 18 months has been used in clinical trials in patients with chronic venous ulcers, ischemic stroke, or metabolic syndrome.Arosio 2001, Tufano 2010, Valvano 2015

Pregnancy / Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking.

Interactions

None well documented. Mesoglycan has been used without safety concerns in numerous clinical trials as add-on therapy to regimens that included immunomodulators, immunosuppressives, calcium channel blockers, prostanoids, angiotensin receptor blockers, ACE inhibitors, methylprednisolone, methotrexate, cyclosporine, and simvastatin in patients with hypertension, dyslipidemia, diabetes, metabolic syndrome, multiple sclerosis, and Raynaud phenomenon.Di Biase 2013, Gossetti 2015, Napolitano 2014, Tufano 2010

A review of mesoglycan studied in vascular diseases reported that activated partial thromboplastin time values increased 2 times that of control in 81% (n=29) of patients during intravenous administration of mesoglycan; values returned to normal at the end of administration.Tufano 2010

Adverse Reactions

Mesoglycan has been well tolerated in studies; 2 minor cases of headache and diarrhea have been reported.Tufano 2010

An erythematous irregular bald patch of alopecia was observed a few days after a mesotherapy session with a formulation that contained mesoglycan (Prisma). At 3 months, a small area of residual cicatricial alopecia persisted. Hair loss has been previously associated with heparin derivatives.Duque-Estrada 2009

Toxicology

No data.

References

Allegra C, Antignani PL. Quality of live as measured by the CIVQ 20. Questionnaire following oral mesoglycan treatment of patients with chronic venous disease. Int Angiol. 2014;33(5):407-418.24566500
Andreozzi GM. Effectiveness of mesoglycan in patients with previous deep venous thrombosis and chronic venous insufficiency. Minerva Cardioangiol. 2007;55(6):741-753.18091643
Arosio E, Ferrari G, Santoro L, Gianese F, Coccheri S; Mesoglycan Venous Insufficiency Group. A placebo-controlled, double-blind study of mesoglycan in the treatment of chronic venous ulcers. Eur J Vasc Endovasc Surg. 2001;22(4):365-372.11563899
Di Biase A. Mesoglycan treatment in Raynaud phenomenon: a case series. Minerva Cardioangiol. 2013;61(3):323-331.23681135
Duque-Estrada B, Vincenzi C, Misciali C, Tosti A. Alopecia secondary to mesotherapy. J Am Acad Dermatol. 2009;61(4):707-709.19577328
Ferrara F, Ferrara G. Treating telangiectasias: my method. Minerva Cardioangiol. 2013;61(2):221-227.23492605
Gossetti B, Antignani PL, Jabbour J, Martinelli O. Flow-mediated dilation benefits of mesoglycan in peripheral artery disease. Int Angiol. 2015;34(4):398-406.25972138
Lee KY, Lee DH, Choi HC. Mesoglycan attenuates VSMC proliferation through activation of AMP-activated protein kinase and mTOR. Clin Hypertens. 2016;22:2.26893937
Lotti T, Celasco G, Tsampau D, et al. Mesoglycan treatment restores defective fibrinolytic potential in cutaneous necrotizing venulitis. Int J Dermatol. 1993;32(5):368-371.8505166
Mansi D, Sinisi L, De Michele G, et al. Open trial of mesoglycan in the treatment ofcerebrovascular ischemic disease. Acta Neurol (Napoli). 1988;10(2):108-112.2969172
Maresca L, Foggia C, Leonardo G. Restoring microvascular efficiency with mesoglycan in women affected by moderate chronic venous disease. Minerva Cardioangiol. 2015;63(2):105-111.25711836
Napolitano M, Bruno A, Mastrangelo D, et al. Endovascular treatment of chronic cerebro spinal venous insufficiency in patients with multiple sclerosis modifies circulating markers of endothelial dysfunction and coagulation activation: a prospective study. Blood Coagul Fibrinolysis. 2014;25(7):716-720.24806325
Nelson EA. Venous leg ulcers. BMJ Clin Evid. 2011;2011.22189344
Orefice G, Brancacio V, Coppola G, et al. Comparative effects of mesoglycan and ticlopidine treatment on some coagulative parameters in patients with previous ischemic stroke: results of a randomized controlled trial. Curr Ther Res. 2002;63(5):337-343.
Orlandi G, Viapiano F, Massetani R, Ferrari M, Murri L. Clinical-instrumental evaluation of the effects of mesoglycan sulphate in chronic vascular encephalopathy. Acta Neurol (Napoli). 1991;13(3):255-260.1833956
Pacella E, Pacella F, Turchetti P, et al. A pilot clinical study on the effectiveness of mesoglycan against diabetic retinopathy. Clin Ter. 2012;163(1):19-22.22362228
Ryu JH, Kim SJ. Clopidogrel effectively suppresses endothelial microparticle generation induced by indoxyl sulfate via inhibition of the p38 mitogen-activated protein kinase pathway. Blood Purif. 2011;32(3):186-194.21811066
Tufano A, Arturo C, Cimino E, et al. Mesoglycan: clinical evidences for use in vascular diseases. Int J Vasc Med. 2010;2010:390643.21152191
Valvano A, Bosso G, Apuzzi V, Riccone F, Saccà L, Oliviero U. Mesoglycan improves vascular reactivity and insulin sensitivity in patients with metabolic syndrome. Atherosclerosis. 2015;243(2):407-413.26520894
Varatharajan L, Thapar A, Lane T, Munster AB, Davies AH. Pharmacological adjuncts for chronic venous ulcer healing: a systematic review. Phlebology. 2016;31(5):356-365.26036247
Vecchio F, Zanchin G, Maggioni F, Santambrogio C, De Zanche L. Mesoglycan in treatment of patients with cerebral ischemia: effects on hemorheologic and hematochemical parameters. Acta Neurol (Napoli). 1993;15(6):449-456.8160557
Viliani T, Scarselli M, Pieri A, Gatti M, Santini M, Pasquetti P. Pharmacological treatment of mechanical edema: a randomized controlled trial about the effects of mesoglycan. Eur J Phys Rehabil Med. 2009;45(1):21-29.19270639

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