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Calls for govt probe into acne drug's side effects

Women in the UAE have demanded that local health authorities launch a probe into the side effects of a locally available drug 'Diane 35' used to treat acne and hirsutism.

The call came following reports that Britain’s Medicines and Healthcare Products Regulatory Authority was reviewing Dianette — also known as Diane 35 — after a London-based charity presented a dossier containing reports from 100 women who said they experienced serious depression while on the drug, as well as mood swings and a compulsion to harm themselves.

The pill is used by thousands of women the world over to treat acne and hirsutism but also acts as a contraceptive, though it is not registered for this purpose. The dossier that was presented to the British drugs watchdog was compiled by the UK-based charity April (Adverse Psychiatric Reactions Information Link).

Local doctors say that the effect of the drug varies from person to person. “Not everyone suffers from adverse effects as this depends on the individual's ability to metabolise (disperse) the drugs,” they say.

Speaking to Khaleej Times, Dr Tazyeen Faisal, Specialist Obstetrician and Gynaecologist with Canadian Specialist Hospital, said: “Post-natal blues are already a known entity, but they could be triggered by certain drugs. But until it is proven that the drug is really having a serious side effect on a number of women, we cannot really pinpoint the cause. But normally, drugs such as Diane 35 which can be used as contraceptives, though not recommended, have hormones including tetestrone and progestrone may cause some forms of depression.”

She also said that some patients did complain of depression after using Diane 35, but added: “Most women are unaware of how their bodies work and react, especially women from the Indian subcontinent. Therefore, the cause of depression has not been linked to the use of this particular drug.”

“The best part is that as soon as patients stop using the drug, the effects can disappear. We do not have cases of prolonged symptoms caused after such drugs have been stopped,” she noted.

Said Dr Justin, a gynaecologist at Jebel Ali Hospital,: “In responding to the effects caused by the drug, we have to balance the risks and family history of the patient. I know that several women, including young girls, commonly use the drug the world over to appear beautiful by treating hirsutism.”

Dr Justin said that it was worth while to launch an investigation into the side effects caused by the drug because patients had complained of mood swings while using this drug as it contained the hormone progestrone. “In 1995, Diane 35 was banned in the UK because it caused a kind of thrombosis in the legs, but later it was reintroduced in the market because it was proved that the drug was beneficial in treating diseases related to chlolesterol,” she explained. The use of this drug was subjective.

On the web site of the UK-based charity, it’s founder Millie Kieve says, “We have received approximately 100 reports of depression, self harm and even suicide attempts caused by Dianette (Cyproterone Acetate). Many people had never suffered from depression prior to taking this drug. On stopping the drug most of the young women have informed us that they are back to their former, in most cases, happy selves. Dianette is prescribed for acne, and other hormonal problems and it is also used as a contraceptive (though not licensed for this purpose).”

She also says, “Somewhere on the label it tells you that you might suffer ‘mild side effects’ such as depression and losing interest in sex. But these are not mild effects — they are serious and they can mess up people’s lives. Many women taking the drug have said that their lives had become unbearable, and it was only after they stopped taking the drug that they realised that it was the cause.”