MHRA Dianette correspondence
History of APRIL's efforts to change the information available to patients about Dianette and the risk of it triggering depression and associated psychiatric problems.We wrote to the Medicines and Healthcare Products Regulatory Agency (MHRA) many times to share the information we received from women about the adverse psychiatric effects they suffered when taking Dianette or Diane 35. At first no one agreed to read the reports from women who wrote to APRIL. We offered over 100 accounts of depression and related problems and evidence from the women who had stopped the drug, to show they felt a 'cloud lifted' when they did stop taking Dianette. Many had been offered antidepressants with no suggestion from their GP that stopping Dianette may be a solution to their new problems. After many letters and a personal meeting with senior employees of the MHRA at the British Museum, when I (Millie Kieve) met with Dr Sarah Wark - it was agreed I could forward the 100 annonimised accounts from women and girls. It was agreed they would be shown to the review committee who would evaluate the evidence about Dianette. Eventually after their review of Dianette the MHRA persuaded the manufacturers to add the following warning to the Patient Information Leaflet (PIL) 4.1 Serious side effects – see a doctor straight away - found in the PIL July 2017Severe depression: Although, it is not considered a direct side effect of Dianette, some women have reported feeling depressed whilst taking Dianette. In very rare cases this has been associated with thoughts of ending their lives. If you develop severe depression, you should stop Dianette as a precaution, and see your doctor straight away. The manufacturers added to the more detailed Summary of Product Characteristics (SPC) - a data sheet that all prescribers should be familiar with, the following statement. Link to SPC July 2017 "Post-marketing reports of severe depression (including very rare reports of suicidal ideation or behaviour) in patients using Dianette have been received. However, a causal relationship between clinical depression and Dianette has not been established." One may wonder at the comment about a causal relationship as the data sheet for the Dianette clearly states under 4.8 Undesirable Effects - Adverse events reported in clinical trials - found in the SPC July 2017Common (≥ 1/100)
The MHRA responded to our many letters emails and personal visits. These are a few of the comments from longer letters: October 2005 - from Dr Jane Woolley Pharmacovigilance Risk Assessment GroupThank you for your email to Dr June Raine about the prescribing of Dianette and its associated risks. This has been passed to me for reply.
A phone number was supplied (now not in use) and the mention of paper forms in GP surgeries is a sore point as no one has ever seen one in a GP surgery or a pharmacy! January 2006 - from Dr Sarah Bourne Pharmacovigilance Risk Assessment Group - Post Licensing Division
I (Millie Kieve) have to report that sadly the data still contains depression and loss of interest in sex as MILD reactions. I requested information about the people on the Expert Advisory Group and did not receive that information from the MHRA. I investigated and could not find anyone who may have a remote idea of the problems such MILD reactions could lead to. However the resulting extra, if guarded, warnings were a small achievement. Links to articles relating to the above information: Related Informations/Articles The Guardian published the following article about our Dianette campaign, this was then picked up by newspapers across the world. Pill under review over link to depression Millie Kieve's story published in The Guardian about Karen Kieve ‘She told me she had lost her personality’ article Contraceptive pill linked to depression article Prescribing advisory blog article and our comments re Dianette article The Pill and depression campaign by Vicky Spratt January 2027 My nightmare on the pill http://www.bbc.co.uk/news/magazine-38575745 article http://www.thedebrief.co.uk/news/real-life/side-effects-of-the-pill-20170166182 article You can follow Vicky on Twitter - Vicky Spratt (@Victoria_Spratt) | Twitter You can follow APRIL on Twitter https://twitter.com/APRIL_charity Band Names for Co-cyprindiol from Wikipedia Brand namesCPA is marketed under brand names including Androcur, Androcur Depot, Androcur-100, Androstat, Asoteron, Cyprone, Cyproplex, Cyprostat, Cysaxal, Imvel, and Siterone. When CPA is formulated in combination with EE, it is also known as co-cyprindiol, and brand names for this formulation include Andro-Diane, Bella HEXAL 35, Chloe, Cypretil, Cypretyl, Cyproderm, Diane, Diane Mite, Diane-35, Dianette, Dixi 35, Drina, Elleacnelle, Estelle, Estelle-35, Ginette, Linface, Minerva, Vreya, and Zyrona. CPA is also marketed in combination with estradiol valerate as Climen, Climene, Elamax, and Femilar |