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Beta-Carotene : Safety
(Page 4 of 5) The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects. Allergies People who are sensitive to beta-carotene, vitamin A or any other ingredients in beta-carotene products should avoid supplemental use. Side Effects and Warnings Likely safe: When beta-carotene is consumed in amounts found naturally in foods, or when consumed in oral supplement doses of 15mg/day or less in people with good general health, when used orally and appropriately. Beta-carotene is likely safe in children, when used orally in amounts commonly found in foods. Beta-carotene is likely safe in pregnant and lactating women, when used orally and appropriately in amounts commonly found in foods. | ||||||||||||||||||||
Possibly safe:When used orally as a dietary supplement. Doses up to 300mg daily have been used with apparent safety for conditions such as erythropoietic protoporphyria. However, doses as low as 20mg daily have been associated with increased risk of lung and prostate cancer in adults who smoke. Although there is no evidence of significant adverse effects of beta-carotene in nonsmokers, the mechanism for cancer promotion is unknown. If beta-carotene supplements are used, it may be advisable to limit daily consumption to 7mg per day until more is known about its long-term toxicity. In children, when used orally as a dietary supplement, high doses (greater than 60mg daily) have been used with apparent safety for conditions such as erythropoietic protoporphyria. Supplemental beta-carotene in children should be limited to specific medical indications. There is insufficient reliable information available about the safety of large doses of beta-carotene in pregnancy and lactation. Possibly unsafe:When used orally in people who smoke or have a history of asbestos exposure. Supplemental beta-carotene 20mg daily for 5-8 years seems to increase the risk of lung cancer, prostate cancer, intracerebral hemorrhage, and cardiovascular and total mortality in people who smoke cigarettes or have a history of high-level exposure to asbestos. Beta-carotene from foods does not seem to have this effect. Plasma concentration of beta-carotene below 0.25 µmole/L has also been associated with an increased risk of cancer. Eating disorders, kidney disorders, and liver diseases may cause high blood levels of beta-carotene, which may increase the risk of side effects. Carcinogenic: Beta-carotene in doses of 20mg daily for 5-8 years has been associated with an increased risk of lung and prostate cancer and increased total mortality in people who smoke cigarettes, and in people with a history of high-level asbestos exposure. Smokers and people with a history of asbestos exposure should not use beta-carotene supplements. These adverse effects do not seem to occur in people who eat foods high in beta-carotene content. Cardiovascular: In people who smoke, beta-carotene 20 to 30mg daily may increase cardiovascular mortality by 12% to 26%. In men who smoke and have had a prior myocardial infarction (MI), the risk of fatal coronary heart disease increases by as much as 43% with beta-carotene 20mg daily. There is some evidence that beta-carotene in combination with selenium, vitamin C and vitamin E might lower high-density lipoprotein 2 (HDL2) cholesterol levels. HDL levels are protective so this is considered to be a negative effect. Dermatologic: Reversible yellowing of palms, hands, or soles of feet and to a lesser extent the face (called carotenoderma) can occur with high doses of beta-carotene. Gastrointestinal: Loose stools and diarrhea have been reported. Musculoskeletal: Joint pain has been reported. Hematologic: Unusual bleeding or bruising has been reported. Central nervous system: Dizziness has been reported. Pregnancy and Breastfeeding FDA Pregnancy Risk Factor C. Insufficient data are available on larger oral doses of beta-carotene in pregnant and lactating woman.
About the Author medlineplus.gov |
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