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Schering pill under review after depression link

MHRA investigating claims that women suffered psychiatric side-effects after treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has ordered a review into Schering Health Care's contraceptive, Dianette, after more than 100 women said they became seriously depressed after taking the drug.

A dossier of evidence about possible side-effects was submitted to the UK regulator by the charity APRIL (Adverse psychiatric Reactions Information Link).

However, the MHRA has verified that Dianette is still on the market and it is merely reconsidering the wording of the patient information leaflet.

Dianette is licensed as a hormone treatment for severe acne, but only in cases where other treatments have been tried and seen not to work. While it is an effective contraceptive, doctors have advised that it should not be prescribed solely for this purpose because of the higher risk of blood clots than other similar combination pills.

Women who take the pill are supposed to stop treatment within three to four months of their skin problems clearing up. However, some women who contacted APRIL said they had been on the drug for several years.

Some women said they had been prescribed anti-depressants by their doctors after taking Dianette.

On the charity's website, APRIL founder Millie Kieve said she had ìasked the regulator to take notice of the hundreds of reports of depression that have been sent to APRIL and the fact that many young women are not being warned of risks of long term usage. Some girls reported taking Dianette for up to 10 years.î

In March, after the review began, the MHRA granted a licence to an identical generic product, Clairette.

In a statement, the MHRA said ìdepression is a known adverse reaction of Dianetteî. It added that the evidence from April was ìnot felt to impact sufficiently on the balance of risk and benefits of the product to stop the licensing of a similar generic productî.

The findings will go to the MHRA's expert advisory group on medicines for women's health at the end of this month.

A spokeswoman for Schering Health Care, which manufactures Dianette, said the firm had not been informed by the MHRA of any review of the drug.

ìWe liaise closely and co-operate fully with the MHRA on all matters of patient safety,î she added.

30th September 2008

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