Australian women still being prescribed Diane-35 as contraceptive pill despite regulator warnings

Updated

Australian women are still being prescribed a contraceptive pill temporarily banned in France earlier this year, in breach of the advice of the medicines regulator.

An ABC News investigation has found Diane-35 is still routinely prescribed off-label even though it is only approved in Australia as an anti-acne medication.

It can be used as contraceptive in women with hormonal problems.

The Therapeutic Goods Administration (TGA) said it would investigate claims the drug's manufacturer Bayer breached laws that prevent them marketing the drug as a contraceptive.

The drug was described as a "contraceptive" on the company's website until this week, when it amended the site following inquiries from the ABC.

Diane-35 was temporarily banned in France in January following a spate of deaths after its regulator found the increased risk of blood clots outweighed its potential benefits.

The TGA's advice on the drug has long been that it is only approved for use as a short to medium-term treatment for acne and other hormonal conditions.

While it also works as a contraceptive for prescribed patients, it does not have approval for that specific use.

The medicine is not listed on the Pharmaceutical Benefits Scheme and sales of the drug are hard to track.

Woman describes stabbing pain after developing blood clot

Gold Coast woman Suzanne Lynch developed a blood clot in her lungs after being on Diane-35 for four months.

Ms Lynch was prescribed the medication by a doctor who was not her usual general practitioner and failed to pick up a family history of blood clots.

"It was like someone had a knife and they were stabbing me in the back and it was very difficult to breathe," she said.

She was in hospital for two weeks and had to be on blood-thinning medication for months.

"If it's just prescribed without thorough investigation I think it should be not allowed," she said.

"My skin did clear up but sadly it nearly killed me."

Medical history important to take into account, says pharmacist

Not-for-profit group National Prescribing Service (NPS) MedicineWise says it regularly receives calls from women who take the medicine as a contraceptive.

NPS pharmacist Sarah Spagnardi says many women started on the pill for acne but stayed on it long-term to prevent pregnancy.

"Anecdotally, the NPS does have information to suggest that women are using Diane solely as a contraceptive agent," she said.

"Off-label prescribing... is a reasonably widespread practice.

"I don't think there's a need for concern particularly as long as the prescriber is taking into account the risk factors, taking into account medical history."

Retail pharmacists support their position, telling the ABC the drug is still routinely stocked on shelves but that sales had dropped off following negative publicity in January.

The active ingredient in Diane-35 is cyproterone with ethinyloestradiol and it is also sold in Australia under the generic names Estelle, Brenda, Juliet and Laila.

In May, the European Commission overruled French authorities and the ban on Diane-35 was overturned.

Risk versus benefit

Published studies indicate the risk of blood clots from Diane-35 and its generics is up to two times higher than other oral contraceptives and four times higher than women not taking the pill at all.

Some doctors are less concerned about risks posed by Diane-35 and its generics, saying there is a higher risk of blood clots during and after pregnancy, which the pill prevents.

Obstetrician Steve Robson says doctors need to take a detailed history of patients when prescribing Diane-35 and monitor patients closely.

"Prescribing the pill is not a simple thing at all," he said.

"It's important that every woman who is being treated with the contraceptive pill of any type, whether it's Diane or any type, that they're not given endless repeats of prescriptions for the pill - that every opportunity is taken to review the woman."

Dr Robson says Diane-35 did have a role to play as a medication.

"This class of contraceptives are very commonly used and they have a valuable role in managing patients for example who have polycystic ovary syndrome," he said.

"Women should not be afraid for a prescription for the pill if they take all the precautions."

The TGA says its review of the safety information was that the benefits outweighed the risks and it should continue to be available for acne and other androgenisation conditions.

Medicos risk lawsuits if patients become ill, say lawyers

A spokeswoman for Bayer says the medication had a favourable benefit-risk profile when used as directed.

"Diane-35 has been available for over twenty years and there has been no new scientific evidence to change the positive benefit-risk assessment conducted by the regulatory authorities," she said.

"The benefits of Diane-35 outweigh the risks for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age."

South Australian solicitor Tim White is representing women in a class action against the makers of other contraceptives Yaz and Yasmin.

Mr White says there were examples among his clients of off-label prescribing.

Mr White warned doctors who prescribe Diane-35 off-label they could be exposing themselves to potential law suits if patients become ill.

"If Diane-35 has been approved for the treatment of severe acne then it should only be prescribed to women that have that complication," he said.

"Further to that, it also is a requirement that they've tried other means of treatment prior that's been unsuccessful.

"If medical practitioners aren't following that strict criteria then they certainly could be liable for the damages suffered."

Do you know more? investigations@abc.net.au

Topics: contraception, reproduction-and-contraception, health, australia, france

First posted