Long-term risks of Depo-Provera drug 'never mentioned', patients claim

More Australian women have come forward with concerns about serious side effects from the popular contraceptive Depo-Provera, with many claiming they were not made aware of the risks of the high-dose hormone.

Yesterday, the ABC reported on a possible class action looming over the increased risk of benign brain tumours caused by long-term use of the drug.

However, several women claim their health has been significantly impacted due to other serious side effects including osteoporosis — and their treating doctors never made them aware of the risks.

Tracey Lintern said she has endured 15 broken bones in five years including five ribs, her patella, feet, toes and wrist.

Ms Lintern said she developed osteoporosis in her forties after being on Depo-Provera for nearly 15 years.

"My husband reckons I sneeze and I break," she said.

"I'm constantly awake throughout the night. I can't get comfortable."

The mother and grandmother said she was never told she shouldn't be on the contraceptive for more than two years.

"My doctor wasn't aware of the issue, it wasn't written on the [outside] packaging," she said.

"They throw out the box — you don't get to see anything."

She believes Depo-Provera should be banned.

Depo-Provera is a high-dose injection of a specific synthetic progesterone known as medroxyprogesterone acetate, given to women every three months for contraception.

More than a decade ago Donna McLean's gynaecologist prescribed her regular injections of the contraceptive Depo-Provera to help with heavy periods.

The injections continued for 10 years, during which the mother-of-one noticed thinning hair, regular headaches and declining vision.

The Melbourne woman also has Crohn's disease, an inflammatory bowel condition, and she put the symptoms down to this as well as household contamination issues she was dealing with related to her plumbing.

It wasn't until she came off Depo-Provera earlier this year and her symptoms vastly improved, that she came to believe it was the cause.

"It's a dangerous medication and we're not being told about it," she said.

Ms McLean is one of many women raising concerns about the popular contraceptive after a landmark study in March found a five-fold increased risk of developing a common benign brain tumour.

The study found long-term use of Depo-Provera was linked to a higher rate of tumours known as meningioma.

It's prompted lawyers in Australia and overseas to start recruiting participants for possible class actions.

Women claim they weren't informed of side effects

Like Ms Lintern, Ms McLean is particularly concerned her gynaecologist never told her that patients were only supposed to take the high-dose contraceptive for two years due to its links to osteoporosis — after two years doctors should consider alternatives and weigh risks.

Due to her Crohn's disease Ms McLean has a corticosteroid called prednisolone regularly and if combined with Depo-Provera, it greatly compounds her risk of osteoporosis.

"They're not really safe side effects — they're actually serious and dangerous side effects," she said.

"They need warnings on the box. A big sticker that says: 'this could cause osteoporosis'.

"They put them on cigarette boxes. Why shouldn't they put them on these?"

In Australia the official product information leaflet in the box for Depo-Provera does include the osteoporosis risk.

It also warns about vision disorders, headaches and thinning hair as well as a link to types of breast cancer.

However, many women, including Ms McLean said because the contraceptive is given as an injection administered by a doctor or practice nurse, they never saw this leaflet as it was thrown away by the surgery.

Many relied on their doctor or nurse to talk through the risks, but most said their GP or gynaecologist never mentioned the two-year recommendation.

"I just think we need to be told," Ms McLean said.

Dr Nisha Khot from the Royal Australian and New Zealand College of Obstetricians and Gynecologists said it was an issue of patients giving "informed consent" to treatments.

She agreed doctors should be talking to women about the osteoporosis risk, especially if they were young women and still forming bones.

"If they had not had a discussion with their doctor about what the possible side effects are of being on long term Depo-Provera, that would definitely concern me," Dr Khot said.

"Certainly, if you have been on Depo-Provera for more than two years, then my strong message to you would be that it is time to sit down with your GP, your healthcare provider, and discuss what might be the best contraception for you going forward."

She said it was important to remember while a proportion of women had severe side effects, other women tolerated the drug well.

Dr Khot said side effects had to be weighed against the risk of unwanted pregnancy.

Pfizer competing with new-gen contraceptives

The Depo-Provera injection has been prescribed more than 3.5 million times since 1992 but has been in use dating back to the seventies.

It's an injection given at a doctor's office and lasts for three months, meaning women return for shots four times a year.

In addition to its contraceptive use, the high-dose synthetic progesterone is also used as a treatment for some types of breast and endometrial cancer, endometriosis, heavy periods and for people undergoing gender-affirming therapy.

"If there are some women who use the Depo injection as a management option for their endometriosis, it's a good time to reconsider and think about what other options may be available for them," Dr Khot said.

"Fortunately, we have some newer drugs coming on to the PBS, which will work better and have fewer side effects."

Pharmaceutical company Pfizer, the maker of Depo-Provera, has recently launched a new preloaded syringe version of the drug worldwide that can be injected under the skin (subcutaneously) meaning patients can administer it at home without regular visits to the GP.

It's called Depo-SubQ Provera with how-to videos flooding social media.

It comes as Pfizer seeks to compete with a new generation of more convenient long-acting reversible contraceptives such as the Mirena and Implanon.

In a statement Pfizer said patient safety was its top priority.

"Depo-Provera has been approved in more than 60 countries over the last 30 years and has been a safe and effective treatment option for millions of patients during that time."

Therapeutic Goods Administration (TGA) said it considered the benefits for Depo-Provera still outweighed the risks and it was up to health professionals to use the product information and warnings when prescribing the drug.

"Importantly, the TGA does not regulate clinical practice," it said, in a statement.

"How a medicine is used in practice is a matter between the patient and their treating doctor."

Controversial history

Depo-Provera has long been mired in controversy with it being prescribed to drug users, the homeless, prisoners and those in psychiatric hospitals who struggled to take a daily pill.

It was also used to sterilise women with intellectual disability who found periods distressing.

In the nineties it was even touted as a therapy for paedophiles via chemical castration.

The ABC first reported on its use in 1972 when it was considered a successor to the pill. It was available in the United States from the mid-sixties.

Calls for it to be banned date back to 1980 when the ABC reported women who were on it suffered long-term infertility long after injections had worn off — a claim still being made today.

In 1984 the ABC reported claims from community health nurse, Sister Jeanette Kelly, that seven Aboriginal girls were injected against their will with Depo-Provera in Oodnadatta between 1978 and 1981.