Are Side Effect Warnings Serving You?

 

“Despite growing evidence that pharmaceutical products can cause harm, large drug companies often escape accountability while natural products are often dismissed, over-regulated, or discredited for not meeting the costly standards set by those same industries.”

 

I was quite taken back when I recently read how the FDA is considering removing the warnings from their menopause therapy. “The panel concluded that the risks associated with these therapies are lower than previously believed and recommended reviewing and updating outdated restrictions (…) Many women with menopausal symptoms first visit primary care physicians, who are often more cautious when prescribing drugs with these warnings. [They] explained that removing the warning might not drastically change prescribing patterns but could improve adherence, especially for local estrogen therapy, where systemic absorption is minimal.”[1] Their reasoning for these changes is that more and more women opt for HRT, sometimes for preventive reasons, because their symptoms affect their quality of life. Hormonal changes during menopause affect bone health, cognitive function and aging.

I agree, women’s hormones are under attack today, especially after Covid, but placing warnings on drugs happen for a reason: to alert what side effects may develop, especially using estrogen derived from pregnant mare urine (and hoping it would get absorbed into women without side effects). And then we look at the side effects that our new Balanced formula has, which is a natural treatment for women going through menopause, a natural plant based product, yet we have to provide the same warnings that the drug company uses. Or maybe now they will not have to list the warnings but I am sure they will not give natural health products the same luxury.

How the FDA deals with side effects

A randomized clinical trial Women’s Health Initiative (WHI) estrogen‑plus‑progestin trial[2], which enrolled 16,608 post-menopausal women aged 50-79 years with an intact uterus, began in 1993. It was part of the larger WHI program launched by the National Institutes of Health (NIH) to study strategies for preventing heart disease, breast and colorectal cancer, and osteoporosis in postmenopausal women. Participants were randomly assigned to receive a daily combination of estrogen + progestin (brand name Prempro) or a placebo. The main objective was to test whether estrogen + progestin could prevent chronic disease (including heart disease and hip fractures) in healthy women, rather than treating menopausal symptoms. The trial was planned to end in 2005 but was terminated in 2002 due to increased health risks observed in the hormone therapy group.

“The results showed that during one year, among 10,000 postmenopausal women with a uterus who are taking estrogen plus progestin, one can expect that eight more will have invasive breast cancer, seven more will have a heart attack, eight more will have a stroke, and 18 more will have blood clots, including eight with blood clots in the lungs, than will a similar group of 10,000 like women who are not taking these hormones.”[3]

What did these findings mean compared to the placebo group? It meant 29% increase in heart attacks, 41% increase in strokes, 111% increase in venous thromboembolism (blood clots), 26% increase in invasive breast cancer and, as a benefit, reductions in hip fractures (33%) and colorectal cancer (37%).

Other studies also found the negative effects of synthetic progestin. According to the study Progestins and the Risk of Breast Cancer[4] natural or bioidentical progesterone (i.e., micronized progesterone) appears to have lower associated breast-cancer risk when combined with estrogen, compared to many synthetic progestins. For example, one meta-analysis found a relative risk (RR) of about 0.67 (95% CI 0.55-0.81) for progesterone vs synthetic progestins when each was used with estrogen.

We can also look into the development of the injectable contraceptive Depo‑Provera (medroxyprogesterone acetate, or MPA), beginning with its synthesis in 1954 by Upjohn Company, now part of Pfizer. Initially developed for conditions such as endometriosis, fibroids, and cancer, MPA’s capacity to suppress ovulation made it a promising long-acting contraception option. The drug underwent clinical trials in the 1960s and 1970s, often in vulnerable populations in developing countries, raising ethical concerns about informed consent and side effects (including bone-density loss and menstrual irregularities).

After concerns about side effects came to light, the U.S. Food and Drug Administration (FDA) rejected Depo-Provera for contraceptive use in the U.S. in 1974, but later approved it in 1992 with warnings about bone mineral loss, irregular bleeding, and mood changes.

A March 2024 study[5] published in The BMJ found an association between long-term MPA injection use (one year or more) and a 5.6-fold increased risk of intracranial meningiomas (brain tumors). More precisely, the study looked into several progesterone products and found that women who used certain hormonal drugs had a higher chance of developing meningioma, especially with long-term use (one year or more). For example, women using medrogestone had about 3.5 times higher odds (0.2% of cases vs. 0.1% of controls), those using injectable medroxyprogesterone acetate such as Depo-Provera had about 5.6 times higher odds (0.05% vs. 0.01%), and those using promegetone had about 2.4 times higher odds (0.5% vs. 0.2%). No increased risk was found for natural progesterone, dydrogesterone, or levonorgestrel IUDs. As expected, very high risks were seen with cyproterone acetate (about 19 times higher, 4.9% vs. 0.3%), nomegestrol acetate (about 5 times higher, 5.1% vs. 1.2%), and chlormadinone acetate (about 4 times higher, 3.5% vs. 1.0%).

Litigation against the manufacturer (Pfizer Inc.) began in fall 2024 on behalf of women who developed meningiomas after prolonged use of Depo-Provera and the number of claims has still been growing.

Doctor’s Choice Balanced

Doctor’s Choice Balanced is a special formulation intended to help women ensure the inner balance.  Both traditional and modern ingredients have been combined in a synergistic, nutrient-rich formula. When you read what each ingredient in Balanced does, it seems amazing; they have been used traditionally for hundreds of years without side effects. Of course, we need to list the cautions and warnings on our labels and we must direct those with concerns when taking Balanced to first get the approval from their healthcare provider. We must keep in mind that a healthcare provider does not only include medical doctors, many cultures have their own licensed healthcare provider: it could be Ayurvedic doctors or practitioners, Doctors of Traditional Chinese Medicine (TCM) or homeopathic practitioners or naturopathic doctors. Many of these alternative practices are increasingly being integrated with conventional medicine in an approach known as integrative health.

Here are the ingredients of Balanced and their benefits:

L-Arginine: helps support a modest improvement in exercise capacity in individuals with stable cardiovascular disease. Studies suggest that sexual maturity may be delayed by its deficiency. Arginine is found in seminal fluid, and is also involved in the functioning of a variety of enzymes and hormones.

Black Cohosh: this herb is widely relied upon for relief of hot flashes, menstrual cramps, and morning sickness.  It is also useful in cardiovascular and circulatory disorders.

Dong Quai: this “ancient Chinese secret” increases the effects of ovarian and testicular hormones, and is useful in relieving hot flashes, menopausal symptoms, PMS, and vaginal dryness.

Damiana: an ancient herb which stimulates muscular contractions of the intestinal tract and brings oxygen to the genital area.  It is an energy tonic, a remedy for sexual and hormonal problems, and is known as ‘a “sexuality tonic”.

Soy Isoflavone – non-GMO: Doctor’s Choice’s non-GMO soy isoflavones are plant-derived compounds which mimic estrogen activity, making them popular as a “natural” way to reduce menopausal symptoms such as hot flashes, and for other health benefits.

Licorice Root: well-known for its multiple benefits, licorice root promotes adrenal gland function, and creates estrogen- and progesterone-like effects, as well as improving the quality of mucus, and lengthening intestinal cell life.

Red Clover: its health benefits extend especially to women undergoing menopause, in terms of alleviating symptoms like hot flashes and mood swings. It is also used as a blood and liver purifier and is a traditional treatment for asthma, pertussis, cancer, and gout. Today red clover is often used as an alternative hormone replacement therapy, for high cholesterol, and the prevention of osteoporosis. Despite a lack of high-quality human studies supporting the use of this herb for any medical condition, red clover remains a popular supplement.

Methylcobalamin (B12): a co-enzyme, which is a highly absorbable form of Vitamin B12.  Reports suggest that it helps reduce neurotoxicity and excess glutamate levels, resulting in the lessening of fatigue, stabilization of mood, and improvement of memory.

Folic Acid (methylated folate): widely regarded as a brain food, folate helps with depression and anxiety.  Women taking oral contraceptives should be aware that these medications may increase the need for folate. Supplementation is known to reduce the risk of neural tube defects when taken daily, both prior to becoming pregnant and during early pregnancy. Folate helps to form red blood cells and prevents folate deficiency.

Rosemary Leaf: in herbal medicine rosemary is reported to help improve memory, relieve muscle pain and stimulate the circulatory and nervous systems. Useful for stimulating the immune system and improving digestion, rosemary leaf contains anti-inflammatory compounds, and is traditionally used to help reduce the severity of asthma attacks and relieving bronchial congestion.

Muira Puama Bark: bearing the self-explanatory nickname of “potency wood”, the bark of this small tree from the Brazilian Amazon is suggested for use in improving the psychological and physical aspects of libido and sexual function in both men and women, as well as for menstrual cramps and PMS.

Red Raspberry Leaf: helpful in promoting the overall health and well being of a woman during pregnancy, red raspberry is considered a tonic for pregnant women, boosting their overall health and immune system. Those having menstrual irregularities can take red raspberry tea to help regulate their menstrual cycle, and reduce the symptoms of premenstrual syndrome.

Chaste Tree Berry: long-used by herbalists, chaste tree berry helps to regulate hormone imbalances in women and lower the testosterone levels in men. It is known for its effectiveness in the treatment of menstrual disorders, PMS, menopausal symptoms such as breast tenderness, hot flashes and mood swings, infertility, and decreased milk production in lactating women.

False Unicorn Root: a traditional herbal remedy used by Native American women to deter miscarriage, false unicorn root is still widely used to treat a variety of problems unique to the female reproductive system.

Pyridoxal-5-Phosphate (B6): the active methylated form of Vitamin B6, P5P is involved in more bodily functions than any other single nutrient, and affects both our physical and mental health.

P5P is recommended for many purposes, and is of special value to women. It is used in herbal medicine to help relieve premenstrual symptoms, and give relief from menopausal symptoms and menstrual pain.  It acts as a calmative to ease nervous tension and help the body to handle stress.  It helps soothe muscle and joint pain associated with rheumatic conditions such as rheumatoid arthritis, osteoarthritis, and/or fibrositis, as well as pain of neuralgia, such as sciatica. A minimum of 6 months’ supplementation with P5P will help to reduce loss of bone mineral density (BMD) in post-menopausal women, when combined with adequate amounts of both calcium and Vitamin D. There’s still more: P5P helps to maintain your overall good health, and to metabolize carbohydrates, fats, and proteins.

Cautions/ Warnings / Contra-indications:

Consult a healthcare practitioner if symptoms persist or worsen or prior to use if you have a liver disorder or develop liver-related symptoms (e.g. abdominal pain, jaundice, dark urine), if you have a history of hormonal or gynaecological disease, including ovarian cancer, endometriosis, and/or uterine fibroids or if you are taking blood thinners, or hormone replacement therapy (HRT) including thyroid hormone or if you are taking hormone-containing medications such as progesterone preparations, oral contraceptives, or other HRT products. Ensure you are up-to-date on mammograms and gynaecological evaluations prior to use. Do not use if you have hypokalemia, high blood pressure, a kidney or cardiovascular disorder, if you currently have or previously had breast cancer and/or breast tumours, or if you have a predisposition to breast cancer, as indicated by an abnormal mammogram and/or biopsy, or a family member with breast cancer, or if you are taking thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance. Discontinue use and consult a healthcare practitioner if you experience breast pain, discomfort and/or tenderness or if you experience a recurrence of menstruation and/or uterine spotting. Do not use if you are pregnant, breastfeeding, or attempting to conceive unless you have consulted with a health care practitioner/health care provider/health care professional/doctor/physician. Keep out of reach of children.

Clearly, the whole situation is upside down. Despite growing evidence that pharmaceutical products can cause harm, large drug companies often escape accountability while natural products are often dismissed, over-regulated, or discredited for not meeting the costly standards set by those same industries. This imbalance reflects the need for a more transparent approach that evaluates both pharmaceutical and natural treatments on their actual safety and effectiveness, rather than their market power.

Natural Hormone-Free Replacement Protocol:

Additional Reading:

 

References:

[1] Simón, Clara. 2025.

[2] Rossouw, Jacques E et al. 2002.

[3] Berg, Barbara. 2002.

[4] Mastorakos, G et al. 2021.

[5] Roland, Noémie et al. 2024.