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Black Cohosh, Cimicifuga racemosa oral dosage forms

What is black cohosh, Cimicifuga racemosa?

BLACK COHOSH or Cimicifuga racemosa (Estroven™, Olivia's Secret™, Remifemin™, One-A-Day® Menopausal Health, and many others) is a dietary supplement (herbal remedy) that is being promoted to help support female health problems, like the symptoms of menopause (hot flashes). Unlike estrogens, there is no evidence at this time that black cohosh is helpful for preventing brittle bones (osteoporosis) or that it protects against heart disease after menopause. Black cohosh is also promoted to ease menstrual pain or pre-menstrual syndrome (PMS). Nurse-midwives sometimes use black cohosh as an aide during labor, however, the risks of use during pregnancy or labor are not fully known. The FDA does not recognize black cohosh as being safe or effective for any use at this time, and warns against its use in pregnancy.

Many women may want to discuss the risks and benefits of both drug and herbal treatments with their prescriber prior to choosing treatments. Many black cohosh products are combined with other herbs or vitamins, so you should be aware of the other ingredients in these products.

What should my health care professional know before I use black cohosh?

It is important for you to tell your prescriber or other health care professional that you are using. Some herbs exert potent effects and may interact with other drugs you are taking.

You should discuss black cohosh with your health care professional BEFORE taking it if you have any of these conditions:

  • cancer

  • diabetes mellitus

  • endometriosis or uterine fibroids

  • high blood pressure

  • infertility

  • kidney disease

  • liver disease

  • menstrual changes or irregular periods

  • mood swings

  • unusual vaginal or uterine bleeding

  • an unusual or allergic reaction to black cohosh, soybeans, tartrazine dye (yellow dye number 5), other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Black cohosh is usually taken orally (i.e., swallowed) with a sip of water. Follow the directions on the package labeling, or talk to your health care professional.

Black cohosh should not be used for longer than 6 months without the advice of a health care professional. Do not use if you are pregnant or breast-feeding. Talk to your obstetrician-gynecologist or certified nurse-midwife.

This herb is not for use in children under the age of 18 years.

What if I miss a dose?

Missing a dose is probably not harmful. If you miss a dose, simply resume taking it on your previous schedule. Do not take double doses to catch up, however.

What drug(s) may interact with black cohosh?

  • blood pressure medications (may increase or decrease blood pressure medicine effects)

  • estrogens and other female hormones

  • fertility treatments

  • medicines for treating diabetes (may cause changes in blood sugar control)

For many herbs, interactions with other medications are unknown. That is why you should always be careful when mixing herbal remedies with traditional medications. If you take any other medications, consult with your health care professional prior to taking black cohosh.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking black cohosh?

Since black cohosh is derived from a plant, allergic reactions are possible. Stop using this herb if you develop a rash. You may need to see your health care professional, or inform them that this occurred. Report any unusual side effects promptly.

Different brands of black cohosh might contain different amounts of active ingredient, so be careful to use the same brand. It is recommended that you use a brand from a reliable manufacturer. A standardized product is more likely to contain the same amount of herb from dose to dose. Your health care professional or pharmacist can assist you in finding a product.

If you are taking black cohosh for menstrual or menopausal symptoms, visit your prescriber or health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam while on black cohosh therapy. Follow your prescriber's guidelines.

If you have any reason to think you are pregnant; stop taking black cohosh at once and contact your prescriber or health care professional.

If you are going to have elective surgery, you may need to stop taking this herb before the procedure. Let your health care professional know you are taking black cohosh prior to scheduling the surgery.

What side effects may I notice from using black cohosh ?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • difficulty breathing, shortness of breath, or wheezing

  • easy bruising

  • fast heartbeat, slow heartbeat, or palpitations

  • headache

  • high blood pressure

  • severe nausea or vomiting

  • skin rash or itching

  • swelling of any area of the throat, tongue, skin, or body

  • unusual tiredness

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • heartburn

  • mild upset stomach

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature; do not freeze. Throw away any unused herb after the expiration date.

GENERAL INFORMATION REGARDING DIETARY SUPPLEMENTS:

Dietary supplements include amino acids, vitamins, minerals, herbs, botanicals, and other plant-derived substances, and extracts of these substances. These products are easy to identify as they must state "Dietary Supplement" on the label. A "Supplement Facts" panel is provided on the label for most products. Supplements are not drugs and are not regulated like drugs. You should note that rigid quality control standards are not required for dietary supplements. Differences in the potency and purity of these products can occur. Scientific data to support the use of a dietary supplement for a certain disease or ailment may not be available. This product is not intended to diagnose, treat, cure or prevent any disease.

The Food and Drug Administration suggests the following to help consumers protect themselves:

  • Always read product labels and follow directions.

  • "Natural" doesn't mean a product is safe for humans to take.

  • Look for products containing ingredients with the "USP" notation. This indicates the manufacturer followed the standards of the US Pharmacopoeia.

  • Supplements produced or distributed by a nationally known food or drug company are more likely to be made under tight controls as these companies have standards in place for their other products. You can write to the company for more information about how the product was made.

Publication Source: U.S. FDA-approved Package Insert
Date Last Modified: 9/18/2006