Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Drug safety

European drug safety agency concludes Valette can be used for moderate acne

woman with acne

Source: Shutterstock

Acne: topical treatments or antibiotics should be tried first

The hormonal contraceptive Valette (dienogest/ethinylestradiol; Bayer) can continue to be used to treat women with moderate acne, following a safety review by the European Medicines Agency (EMA).

The drug safety agency says the combination therapy containing dienogest 2mg and ethinylestradiol 0.03mg should only be used when topical treatment or antibiotics have failed and only by women who also want to use an oral contraceptive.

The decision follows a review by the EMA’s Committee for Medicinal Products for Human Use that was initiated at the request of the UK’s Medicines and Healthcare products Regulatory Agency. The MHRA was concerned that the benefits of dienogest/ethinylestradiol have not been sufficiently demonstrated in the treatment of acne and that the risk of venous thromboembolism (VTE) has not been sufficiently characterised.

The EMA says women should be warned about the possible risk of a blood clot associated with hormonal contraceptives in general; the specific risk linked to Valette has still to be confirmed, it says.

“Taking into account the available evidence, and in order not to unnecessarily expose women to a potentially higher risk of VTE, use of dienogest/ethinylestradiol should be restricted to second line and to women who also choose oral contraception,” the EMA concludes.

The EMA bases its recommendation on the results of two phase III trials involving 2,400 women, most with moderate acne. The combination therapy was more effective than placebo and at least as effective as ethinylestradiol/norgestimate and ethinylestradiol/cyproterone when the number of lesions and acne were considered.

Valette is marketed in several European countries but not the UK. It contains a progestogen and an oestrogen, which block the effects of androgen hormones, altering the production of oils in the skin and suppressing ovulation.

The EMA’s recommendation now goes to the European Commission for final approval.

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202275

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now
  • Paediatric Drug Handling

    Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • woman with acne

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.