Bufexamac - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of the safety and effectiveness of bufexamac. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bufexamac do not outweigh its risks, and recommended that the marketing authorisations for medicines containing bufexamac be revoked (withdrawn) throughout the European Union (EU).

What is bufexamac?

Bufexamac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs work by blocking an enzyme called cyclo-oxygenase, which is involved in the production of prostaglandins.
Prostaglandins are messengers in the development of inflammation. Blocking their production helps to reduce the signs of inflammation.

Bufexamac is used to control the symptoms of inflammation of the skin (such as redness and itching) in diseases such as eczema and dermatitis. It can also be used, in combination with other substances, to control the symptoms of inflammation that can occur around the anus in patients with haemorrhoids (piles) or an anal fissure (a tear in the lining of the anal canal).

Medicines containing bufexamac have been authorised in Austria, Bulgaria, the Czech Republic, France, Hungary, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania and Slovakia. They may be available as creams, rectal ointments and suppositories, and under the following invented names: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan, and other trade names.

Why was bufexamac reviewed?

In December 2009, the German medicines regulatory agency completed a review of the benefits and risks of bufexamac-containing medicines. During this review, the agency obtained information from the companies marketing bufexamac in Germany, and looked at published studies on the effectiveness of bufexamac.

The German agency concluded that the benefits of bufexamac-containing medicines do not outweigh their risks, and recommended that the marketing authorisations be withdrawn in Germany.

As required by Article 107, the agency informed the CHMP of its action so that the Committee could prepare an opinion on whether the marketing authorisations for products containing bufexamac should be maintained, changed, suspended or revoked across the EU.

Which data has the CHMP reviewed?

The CHMP looked at the data used by the German agency in its review, and the information provided by the companies marketing bufexamac in other EU countries. In particular, the Committee considered the responses given by the companies to a list of questions on allergic reactions reported following contact with bufexamac.

What are the conclusions of the CHMP?

The CHMP noted that bufexamac-containing medicines have been available since the 1970s, and that contact allergic reactions have been reported over the years, leading to restrictions on the use of the medicines in a number of countries. The risk of developing a contact allergic reaction to bufexamac is high, and the risk is even higher in patients with pre-disposing conditions, such as certain forms of eczema, for which bufexamac is frequently prescribed. The allergic reactions can be serious enough to require hospitalisation. The CHMP also noted that bufexamac is a 'sensitizer' causing reactions to get worse with repeated exposure. Furthermore, because these reactions are very similar to the disease being treated, it can lead to delays in the diagnosis or treatment of the patient's condition. It is also likely that the difficulty to differentiate between a treatment failure and an allergic reaction has led to the cases of contact allergic reaction being underreported.

The Committee noted that the data presented to support the effectiveness of bufexamac were very limited. Most of the studies dated from the original development of bufexamac in the 1970s and 1980s, and were of a lower standard than that expected today. Because of this, no evidence of the effectiveness of bufexamac could be derived from them. In addition, when looking at the few more recent, controlled studies, the CHMP noted that the effectiveness of bufexamac had not been shown.

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of bufexamac-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations be revoked in the EU.

What are the recommendations for prescribers and patients?

• Doctors should stop prescribing medicines containing bufexamac. Alternative anti-inflammatory treatments are widely available.
• Patients currently using bufexamac-containing medicines should speak to their doctor so they can switch to an appropriate alternative treatment.
• Patients who have any questions should speak to their doctor or pharmacist.

A European Commission issued a decision on 27 July 2010.

Questions and answers on the revocation of the marketing authorisations for medicines containing Bufexamac - Outcome of a procedure under Article 107 of Directive 2001/83/EC

Adopted

Key facts

About this medicine

• Approved name:
  Bufexamac
• International non-proprietary name (INN) or common name:
  bufexamac
• Associated names:
  • Parfenac
  • Bufal
  • Calmaderm
  • Fansamac
  • Mastu S
  • Parfenoide
  • Proctosan

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-107/001260
• Type:
  Article 107 procedures (prior to July 2012)

  This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. This procedure has been replaced by Article 107i.

Key dates and outcomes

• CHMP opinion date:
  22/04/2010
• EC decision date:
  27/07/2010

All documents

Bufexamac - Article 107 referral - Annex I, II

Questions and answers on the revocation of the marketing authorisations for medicines containing Bufexamac - Outcome of a procedure under Article 107 of Directive 2001/83/EC

Adopted

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.