Diane-35 Pill Prescribed as Contraceptive in Australia Despite Temporary Ban in France
The contraceptive pill Diane-35 is still being prescribed to women in Australia despite a temporary ban enforced in France earlier in 2013. ABC launched an investigation and found the banned contraceptive pill is still circulating in Australia.
According to the investigation, Diane-35 is "routinely prescribed" as an off-label drug even if it is not authorised as a birth control pill. The drug is only recognised in Australia as an anti-acne treatment but can be used as a contraceptive pill for women having hormonal problems.
The news agency's investigation led the Therapeutic Goods Administration (TGA) in Australia will have its own investigation to verify claims that Diane-35 manufacturer, Bayer, had violated the law in selling the drug as a contraceptive.
Before the inquiries, Bayer's Web site described Diane-35 as a "contraceptive" but the company changed it following the investigation. Previous reports said that France has ordered a temporary ban on Diane-35 in January 2013 after the pill was associated with deaths. The regulator found Diane-35 can increase the risk of blood clots. The risk of developing blood complications far outweigh the drug's benefits.
In Australia, the TGA has ordered the drug to be used only as a medication for acne and other hormonal conditions. While Diane-35 primarily works as a contraceptive, Australia does not allow its use for that specific purpose.
According to the results of the investigation, Diane-35 is not listed on the Pharmaceutical Benefits Scheme. Tracking the sales of the pill also proved to be difficult.
A woman in Gold Coast has developed a blood complication after using Diane-35 as a contraceptive for 4 months. Suzanne Lynch said a doctor, who was not her regular general practitioner, prescribed the drug. The doctor did not inquire if her family had a history of blood clots.
Ms Lynch said she was admitted to a hospital because she was in pain and found it difficult to breathe. She remained in the hospital for about two weeks and was prescribed medication to reduce the blood clot.
Ms Lynch said her skin cleared up because of Diane-35 but it had almost cost her life.
Tim White, a lawyer in South Australia, warned doctors who continue to prescribe Diane-35 to women. He said doctors may be involved in lawsuits if their patients suffer health issues because of the drug. Mr White represents women in a class action against the manufacturers of other birth control pills Yaz and Yasmin.