Various drugs collectively known as Hormone Replacement Therapy (“HRT”) have been recognised as effective treatments for controlling menopausal symptoms. However, there can be some negative consequences associated with the use of HRT that require doctors and patients to weigh up the relative benefits and potential risks of HRT medication.
What is HRT?
HRT replaces the hormones (oestrogen or oestrogen/progestogen) that a woman’s ovaries stop producing when going through menopause. It is available through prescription only and can be prescribed as tablets, skin patches, gels, slow release pellets and nasal sprays.
HRT medication comes in various forms including:
- Oestrogen (or unopposed oestrogen) – this is usually prescribed for women who have had a hysterectomy.
- Combined HRT (oestrogen and progestogen together) is prescribed in two forms involving a daily dose of one or both hormones:
- (1) Cyclical (or sequential) HRT – the woman takes oestrogen every day and adds progestogen for 10-14 days per month.
- (2) Continuous HRT – daily oestrogen and progestogen
Other less common HRTs include:
- High dose progestogen alone
- Tibolone – a drug which acts like oestrogen on some parts of the body and as progestogen on other parts of the body.
There are also complementary medicines and therapies that are available over the counter that can help alleviate symptoms of menopause.
Potential health benefits of HRT
HRT medication (including Tibolone) is effective in treating:
- Hot flushes/night sweats
- Urogenital symptoms
- Sleep problems
- Reduces the incidences of osteoporosis and fracture (however any benefit depends on continued usage)
- Reduces the incidence of bowel cancer (combined HRTs only).
Potential Health Risks
HRT medication can increase the risk of:
- Venous thromboembolism (Deep Vein Thrombosis) and Pulmonary Embolisms
- Endometrial cancer (oestrogen alone)
- Ovarian cancer (oestrogen alone)
- Breast cancer (risk increases with duration of use) (Combined HRT)
When should HRT be avoided?
HRT medication is not recommended for women who have:
- Breast cancer, or clinical symptoms not yet investigated
- Endometrial or cervical cancer
- Liver disease
- History of clotting
- Abnormal genital bleeding
- Conceived and are pregnant.
When might HRT prescriptions give rise to negligence proceedings?
HRTs are still prescribed to help women overcome the symptoms of menopause, and are still the drug of choice under individual circumstances. Issues may arise when a doctor prescribes a HRT medication where the patient suffers one of the aforementioned illnesses such as breast cancer or liver disease. Possible issues may also arise if the prescribing doctor can be shown to have failed to warn the patient of the risks associated with the drug and/or failed to warn the patient of a risk that the patient might attach significance to. The patient should be aware of all potential benefits and risks, and the decision to use HRTs should be informed.
Current litigation concerning the drug
Although there is little litigation in Australia surrounding HRT medication, the United States has been the centre of class action litigation against HRT manufacturers/sellers.
The 2002 US “Women’s Health Initiative Study”, which was backed-up substantially by the British “Million Women Study” in 2003, showed a significantly higher risk of developing breast cancer for women who took HRT drugs at the onset of menopause, compared to those who started taking them later. This finding has resulted in one of the longest running mass tort cases in US history against Wyeth Pharmaceuticals (who sell the Pempro and Premarin brands of HRT drugs). More than 12,000 plaintiffs across the US have sued the company for failing to adequately warn consumers about the risk of the drug, with many of the plaintiffs having developed breast cancer after taking the drug.
How can we help?
If you, or a loved one, have suffered serious side effects whilst taking HRT drugs, our team of highly experienced health lawyers can assist you with providing expert advice and legal support.
Our health law team is highly respected in the health and medical litigation arena, with specialist knowledge accumulated over 25 years. We offer a blend of both legal expertise and clinical knowledge, which has been integral to our many accomplishments in the health field.\
*The material provided in our information sheets is for general knowledge only and is not a substitute for independent legal advice. For further information about the issues affecting you, please contact one of our experienced and professional lawyers for expert advice.