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Healthy Living

ARCHIVED - The Safe Use of Natural Health Products During Menopause

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It's Your Health

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The Issue

Many women seek treatment to relieve the symptoms they have during menopause. While hormone replacement therapy remains a common and effective treatment, more and more women are using natural health products (NHPs) to treat their symptoms. However, as with all health products, NHPs should be used with caution as they may sometimes cause adverse reactions.

Background

Menopause is defined as the end of a woman’s cycle of monthly periods. Menopause is a natural phase of a woman’s life, and it is in progress after 12 months of having no period, as long as it is not caused by a disease condition. The transition to menopause is a complex process that takes place over four stages:

  1. Pre-menopause (a woman’s reproductive or fertile life)
  2. Peri-menopause (the transition immediately before menopause)
  3. Menopause (a woman has had her last period)
  4. Post-menopause (the stage after the last period)

The classic symptoms of menopause develop at the end of peri-menopause and continue throughout the menopausal transition. Women may experience different symptoms such as:

  • hot flushes (often called hot flashes)
  • night sweats
  • mood changes
  • sleep disturbances.

You should consult your health care practitioner to determine if your absence of periods or symptoms are related to menopause.

Natural Health Products Used for Menopause Symptoms

Not all NHPs used by women for the relief of menopausal symptoms have been authorized by Health Canada. Some NHP ingredients, such as black cohosh, are medicinal ingredients in NHPs authorized by Health Canada, specifically to relieve menopausal symptoms. Some products containing valerian, hops, St. John’s wort or lemon balm have been authorized by Health Canada for relief of symptoms, such as sleeplessness or nervousness. However, these symptoms could be related to a variety of medical conditions, including menopause.

In addition to the above, published reports confirm that a variety of other NHP ingredients, such as dong quai, ginseng and evening primrose oil, are used during menopause. Some of these ingredients could appear in an authorized product, but also in an unauthorized product. NHPs that are authorized by Health Canada have a Natural Product Number (NPN), a Homeopathic Medicine Number (DIN-HM) or a Drug Identification Number (DIN) on their label. If you want to know if an NHP is authorized and its recommended use or purpose, see the link to Health Canada’s Licensed Natural Health Product Database (LNHPD) in the Need More Info? section.

Possible Side Effects of Natural Health Products for Menopause

There is limited information from human clinical trials on the safety and effectiveness of NHPs used for menopausal symptoms. Many people think that because NHPs are natural, they are safe. However, NHPs, like other health products, can have serious side effects. Any substance, whether natural or synthetic, that has an effect on the body, has the potential to be a risk to health. As a result, you should use NHPs for menopausal symptoms with caution. Here are some examples of adverse reactions associated with some NHPs:

  • Black cohosh and kava have been linked to rare reports of liver damage.
  • Some NHPs, such as St. John’s Wort may interact with other medications, increasing the risk of harmful side effects.
  • Certain NHPs, such as lemon balm, hops, or valerian, used to decrease nervousness or as a sleep aid, should not be used when driving or operating heavy machinery. They may make you drowsy, and their use with alcohol or with other sedative products is not recommended.
  • Common side effects of many health products, including NHPs, are nausea, vomiting, headache, fatigue and diarrhea.

This is why you should discuss your use of all NHPs and food supplements, as well as any prescription or non-prescription health products you take, with your health care practitioner.

Minimizing Your Risk

You can reduce your risk of adverse effects and help to ensure that the health products you choose are right for your symptoms by taking the following steps:

  • Discuss your symptoms, as well as the risks and benefits of the treatment(s) with a health care practitioner, such as your doctor, pharmacist, or complementary/alternative health practitioner.
  • Carefully read product labels for conditions and directions for use, as well any cautions or warnings. As well, check to see whether the product has a DIN, NPN or DIN-HM on the label. Health Canada is encouraging consumers to use only health products that have been authorized for sale.
  • Be aware of any reaction or interactions with other health products you are taking. Report any adverse reaction to your healthcare practitioner.
  • Consult a healthcare practitioner if your symptoms persist or get worse.

You are also encouraged to report any adverse reaction or interaction involving any health product you take, including NHPs, over-the-counter drugs or prescription medications, directly to Health Canada by calling the toll-free number given in the Need More Info? section.

Natural Health Products Regulations

Health Canada has responded to concerns that consumers want NHPs that are safe, effective and of high quality, by introducing the Natural Health Products Regulations, which require that NHPs sold in Canada be licensed.

The NHP Regulations came into effect on January 1, 2004 and will be completely phased in by December 31, 2009. All NHPs that have been licensed will have a NPN or a DIN-HM on their label. A NPN or DIN-HM lets you know that the product has undergone and passed a review of its formulation, labelling and instructions for use. Until December 31, 2009, certain NHPs may still hold a Drug Identification Number (DIN) if they were authorized for sale before January 1, 2004.

Health Canada’s Role

The Natural Health Products Directorate of Health Canada has developed regulations so that Canadians can have ready access to NHPs that are safe, effective and of high quality, and that respect freedom of choice, as well as philosophical and cultural diversity. The NHP Regulations require that NHP health claims be supported by specific standards and that products are made according to good manufacturing practices in licensed facilities.

The Marketed Health Products Directorate leads the coordination and implementation of monitoring, assessing and, when necessary, intervening for all regulated marketed health product types. These include pharmaceuticals, biologicals, vaccines, medical devices, natural health products, and radiopharmaceuticals.

The Health Products and Food Branch Inspectorate is the third partner in the Natural Health Products Program. The Inspectorate’s role is to deliver a national compliance monitoring and enforcement program for all health products, while supporting the risk-management approach to decision-making. Its activities include compliance monitoring, such as market surveys; product sampling for laboratory analysis; onsite visits at NHP manufacturing sites; compliance verification with respect to product complaints; recall monitoring and customs surveillance; investigation (e.g. actions taken to gather evidence to support a prosecution); and laboratory analysis to determine identity and purity issues, such as contamination or adulteration.

Need More Info?

More information on NHPs, the NHP Regulations, and guidance on interpreting and using this information

For more information on NHPs, you can also go to another It’s Your Health article

For more information on the benefits and risks of HRT, go to the It’s Your Health article

Search Health Canada’s Licensed Natural Health Product Database

To report any adverse reaction or interaction involving any health product, including NHPs, you can:

  • Complete and submit your adverse reaction report online by visiting Adverse Reaction Reporting. Download and print a paper copy of the reporting form, fill it out, and submit the report by mail or fax.
  • Contact Health Canada at this toll-free number 1-866- 234-2345 or by fax at 1-866- 678-6789, or contact your Regional Adverse Reaction Centre

Any suspected adverse reactions can also be reported to:

Canada Vigilance Program
Marketed Health Products Directorate
Health Canada
Address Locator: AL 0701C
Ottawa, Ontario K1A 0L2
Tel: (613) 954-6522 or Fax: (613) 952-7738

For additional articles on health and safety issues go to the It’s Your Health Web section

You can also call toll free at 1-866-225-0709 or TTY at 1-800-465-7735*

Original: August 2009
©Her Majesty the Queen in Right of Canada, represented by the Minister of Health, 2009