Each softgel contains: Borage seed Oil (borago officinalis, supplying 285 mg gamma-linolenic acid [GLA]) 1300 mg • Sesame Seed lignan extract (sesamum indicum) 10 mg. Other Ingredients: Magnesium Stearate, Soy Lecithin, Carob, Glycerin, Gelatin, Water.
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Below is general information about the effectiveness of the known ingredients contained in the product Mega GLA with Sesame Lignans. 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
Below is general information about the safety of the known ingredients contained in the product Mega GLA with Sesame Lignans. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when borage seed oil is used orally or topically and appropriately. Borage seed oil has been used with apparent safety in clinical trials at a dose of up to 4 grams daily for up to 12 weeks (7632,8458,11341,13305,36804,88185,5244).
LIKELY UNSAFE ...when products containing hepatotoxic pyrrolizidine alkaloids (PA) are used orally. Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. 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 borage preparations that are not certified and labeled as hepatotoxic PA-free.
CHILDREN: POSSIBLY SAFE
when borage seed oil is used orally and appropriately.
Borage seed oil has been used with apparent safety at a dose of 2 grams daily for 12 weeks (11341).
CHILDREN: LIKELY UNSAFE
when products containing hepatotoxic PAs are used orally.
Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. 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 to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when products containing hepatotoxic pyrrolizidine alkaloids (PA) are used orally.
Borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic, mutagenic, and teratogenic. These constituents are also excreted in breast milk (12841,12842). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free.
There is insufficient reliable information available about the safety of borage seed oil when used orally or topically during pregnancy or lactation.
LIKELY SAFE ...when used orally in amounts commonly found in food. Sesame has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when sesame oil is used orally and appropriately, short-term. Sesame oil has been used with apparent safety in doses up to 35 grams daily for up to 12 weeks (96179,96180,108354). The sesame constituent sesamin has been used with apparent safety at doses of 200 mg daily for 6 weeks (103230) and 10 mg daily for 12 weeks (99863). Sesame oil 150 mL has also been administered via nasogastric tube with apparent safety as a single dose (27645). ...when sesame oil is used in a nasal spray, short-term. A specific nasal spray (Nozoil) containing sesame oil has been used with apparent safety for up to 20 days (27658,27659,27660). ...when sesame oil is applied topically (96178,103227,103228). There is insufficient reliable information available about the safety of other forms of sesame when used in medicinal amounts.
CHILDREN: POSSIBLY SAFE
when sesame oil is used orally and appropriately in medicinal amounts, short-term.
Sesame oil 5 mL has been used safely at bedtime for up to 3 days (27647).
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of sesame when used in medicinal amounts during pregnancy and lactation.
Below is general information about the interactions of the known ingredients contained in the product Mega GLA with Sesame Lignans. 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, borage seed oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
In healthy individuals, borage seed oil supplementation does not seem to affect platelet aggregation (36823). However, gamma-linolenic acid, a constituent of borage seed oil, seems to decrease platelet aggregation by 45% and increase the risk of bleeding by 40% in animal and clinical research (1979).
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Theoretically, taking borage with drugs that induce CYP3A4 might increase levels of pyrrolizidine alkaloid (PA) toxic metabolites.
Details
Although borage seed oil contains little to no PAs, some borage plant parts, such as the leaf, flower, and seed, can contain hepatotoxic PAs. Hepatotoxic PAs are substrates of CYP3A4, which converts these chemicals into toxic metabolites (12841,12860). Tell patients to avoid borage preparations that are not certified and labeled as hepatotoxic PA-free.
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Theoretically, taking borage sed oil with phenothiazines might increase the risk of seizures.
Details
Borage seed oil contains gamma-linolenic acid (GLA). There is concern that taking supplements containing GLA might cause seizures, or lower the seizure threshold, when taken with phenothiazines. This is based on limited data from two reports published in the 1980s. In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with evening primrose, another source of GLA. However, none experienced an actual seizure (21013). In the other report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose 4 grams daily was added. One of these patients had a prior history of seizures (21010). It is unclear whether evening primrose had any additive epileptogenic effects with the phenothiazines, but there is no evidence that taking GLA-containing supplements alone can cause seizures (88187).
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Taking sesame oil with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Clinical studies show that sesame oil can decrease plasma glucose and glycated hemoglobin (HbA1c) levels. Some clinical research in patients taking glibenclamide shows that using sesame oil or a blend of sesame oil and rice bran oil in place of other oil for cooking reduces plasma glucose more than glibenclamide alone (27654,28139,96177,108350,108352,108355). Monitor blood glucose levels closely. Dose adjustments might be necessary.
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Taking sesame oil with antihypertensive drugs might increase the risk of hypotension.
Details
Clinical research shows that replacing other cooking oil with sesame oil can lower systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with or without hypertension. There is also some evidence that sesame oil has additive effects in patients also taking atenolol, nifedipine, and/or hydrochlorothiazide (27652,27654,27655,96179,108355,108357). In patients using nifedipine, using a blend of sesame oil and rice bran oil for cooking reduces both SBP and DBP more than nifedipine alone (96180).
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Theoretically, sesame might increase the levels and clinical effects of CYP2C9 substrates.
Details
In vitro, sesame inhibits CYP2C9 (11028). However, this interaction has not been reported in humans.
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Theoretically, sesame might alter the transport of P-glycoprotein substrates.
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Theoretically, sesame might interfere with tamoxifen.
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Below is general information about the adverse effects of the known ingredients contained in the product Mega GLA with Sesame Lignans. 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, borage seed oil seems to be well tolerated.
However, borage plant parts, such as the leaf, flower, and seed, that contain hepatotoxic pyrrolizidine alkaloid (PA) constituents should be avoided.
Most Common Adverse Effects:
Orally: Belching, bloating, diarrhea, and soft stools.
Serious Adverse Effects (Rare):
Orally: Borage plant parts that contain PA constituents can be hepatotoxic.
Gastrointestinal ...Orally, borage seed oil can cause soft stools, diarrhea, belching, and bloating (8013,11341).
Hepatic ...The pyrrolizidine alkaloid (PA) constituents of borage can cause significant hepatotoxicity (12841,12842). PAs can occur in borage leaf, flower, and seed; borage seed oil contains little to no PAs. Chronic exposure to other plants containing hepatotoxic PA constituents has been associated with veno-occlusive disease (VOD). Subacute VOD causes vague symptoms with persistent liver enlargement (4021). Symptoms of acute VOD include colicky pains in epigastrium, vomiting and diarrhea, and ascites within several days. Enlargement and induration of the liver occurs within a few weeks (12842).
Oncologic ...The pyrrolizidine alkaloid (PA) constituents of borage are potentially carcinogenic and mutagenic (12841,12842).
Pulmonary/Respiratory ...The pyrrolizidine alkaloid (PA) constituents of borage are potentially pneumotoxic (12841,12842).
General
...Orally, topically, or intranasally, sesame seems to be well tolerated.
Most Common Adverse Effects:
All routes of administration: Allergic reactions.
Dermatologic ...In a small clinical study, one patient using a cream containing sesame oil as well as aqueous extracts of guggul and Allium ampeloprasum complained of rash at the application site (105751). It is unclear if this reaction was due to sesame, other ingredients, or other factors.
Gastrointestinal ...There was a single case of diarrhea associated with oral sesame in a clinical trial (108356).
Immunologic
...Multiple cases of allergic response to sesame seed occurring after occupational, topical, intramuscular, or oral exposure have been reported (28157,28158,28159,28160,28161,28162,28163,28166,28167,28183)(28184,28185,28186,28188,108348).
One study found that up to 0.5% of the United States population reports having a sesame allergy, and 0.23% of the population meets criteria for an IgE-mediated allergic reaction to sesame (100501). Allergic symptoms may be dermatologic, such as angioedema (28160,28167,108348), cheilitis (28207), dermatitis (28157,28166,28182,28185,28186), edema (28159), erythema (28167), pruritis (28167,108348), purpura (28188), flushing (108348), and urticaria (28159,28160,28162,108348); musculoskeletal (28188); respiratory, such as asthma (28159,28162), rhinitis (28162), wheezing (28167), and general breathing difficulties (108348); gastrointestinal, such as vomiting (28159,108348); and others such as conjunctivitis (28159), anaphylactic shock (28157,28159,28160,28167,28177,28178,28179,28180,28204,108348), and hemodynamic modifications (28169). In Canada, sesame accounted for 4% of pediatric food-induced anaphylaxis reactions presenting to emergency departments over a 10-year period. The majority of cases were mild to moderate in severity and occurred within 2 hours of exposure; however, about 3% occurred 2-8 hours after exposure. Epinephrine was the most common treatment, followed by antihistamines, inhaled beta-agonists, and corticosteroids (108348).
Approximately one-third of patients with IgE-mediated sesame allergy have reported previous use of epinephrine due to this allergy (100501). There is evidence that IgE-mediated sesame allergy is influenced by both genetic and environmental factors; there was a high correlation of the allergy between family members, especially siblings (28175).
Allergens believed to be responsible for sesame seed hypersensitivity include beta-globulin (28213); sesamol, sesamolin, and sesamin (28182,28207); storage proteins including ses i 1 and ses i 2 (2S albumins) (28132,28187,28211,28212,28216,28217), ses i 3 (a 7S vicilin-type globulin) (28187,28214), ses i 4 (28158), ses i 5 (28158), ses i 6 (an 11S globulin) (28132,28215), and ses i 7 (28215). Typically allergens in sesame seeds that cause reactions after oral intake have molecular weights ranging from 8-62 kDa (28208,28210).
Pulmonary/Respiratory ...In clinical trials involving a sesame oil nasal spray, minor adverse effects included adverse smell, oil dripping from the nose, and nasal blockage (27659).