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news.UK health regulator the MHRA has reportedly launched a probe to investigate claims that Schering AG's Dianette, a contraceptive commonly used to treat acne, could be linked to depression.
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The MHRA investigation allegedly comes after the charity Adverse Psychiatric Reactions Information Link (April) submitted a dossier of adverse event reports. According to April, there are hundreds of reports of side effects such depression and mood swings linked to Dianette use.
The treatment guidelines for Dianette stress that the drug is only recommended for use in women for the treatment of severe acne refractory to prolonged oral antibiotic therapy, and moderately severe hirsutism. Dianette’s contraceptive indication is also restricted to use in women requiring treatment for the androgen-dependent conditions.
In addition, in a letter to April, an MHRA spokesperson stated that the product’s labeling and patient information leaflet warn women about the known risks of depressive moods associated with Dianette use.
The MHRA reportedly expects to submit its findings to an advisory group by the end of May. However, a Schering spokeswoman is quoted in The Guardian as stating that the company has not been informed by the regulator of the review.