Dianette Diane35 urgent to report sideeffects

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Licensed in UK for acne. Dianette and the generics now have a BLACK TRIANGLE WARNING the drugs are under close scrutiny for ANY adverse side effects. • The boxes SHOULD carry the BLACK TRIANGLE as this is now an EU directive to display this so patients are aware they are taking a drug that has to be closely monitored due to concerns about the safety of the product. March 2014 • Dianette, Diane-33. Co-cyprindiol, Clairette and other generic names is a drug containing cyproterone acetate (anti-androgen) and ethinylestradiol (contraceptive). It has been banned in France and awaits a ruling by the European Medicines Agency (EMA) on safety. • Concerns for many years about the high risk of DVT - thrombosis for women taking this drug have led to warnings in the UK (in 2002) and Canada but the risk is played down. The mother of a young woman who died from dvt linked to Dianette informed me the risk of thrombosis is 4 to 6 times higher with Dianette than other contraceptives. • Please do send in reports to the EMA www.ema.europa.eu put in the name Dianette in search box. If you have suffered an ADR to any drug please report in UK to www.yellowcard.gov.uk • Our charity campaign on creating awareness about depression caused by Dianette led to a review in 2006 by the Medicines Healthcare Products Regulatory Agency (MHRA) and the data sheet was updated to include words about anecdotal reports of depression. Depression is listed as a common side effect on their Summary of Product Characteristics (SPC) at: • http://www.medicines.org.uk/EMC/medic... • However this fact is not clearly stated on the patient information leaflet (PIL). • Information compiled by Millie Kieve - formerly Chair of Advisory Group to the Evaluation of Yellow Card Patient Reporting and founder of APRIL- Adverse Psychiatric Reactions Information Link www.april.org.uk March 5 2013 • PLEASE REPORT adverse drug reactions (ADRs) to www.yellowcard.gov.uk and inform APRIL. Patients can report even if not sure the drug caused the problem and if you are not sure the doctor or coroner sent in a Yellow Card. The EMA web site has lists of reporting agencies in other EU countries.

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