Important notice concerning safety of medicinal products containing the active substance bufexamac with recommendations for physicians, pharmacists and patients
The European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revocation of marketing authorisation for all medicinal products containing the active ingredient bufexamac. Based on the CHMP's opinion, the European Commission will issue final recommendations for the medicinal products containing the aforementioned active substance.
The Agency for Medicinal Products and Medical Devices (HALMED) initiated the review process for the EMA's recommendation, issuing the following recommendations for physicians, pharmacists and patients.
The EMA's Committee for Medicinal Products for Human Use issued a recommendation based on the scientific evaluation which identified a high risk of occasionally serious contact allergy reactions caused by bufexamac. This risk is even higher in patients with predisposing conditions, such as certain forms of eczema, which bufexamac is frequently prescribed for. Furthermore, allergic reactions caused by bufexamac are very similar to the diseases bufexamac is indicated for, which can potentially delay correct diagnosis and therapy. Also, it is possible that the difficulties in differentiating between the disease symptoms and allergic reactions resulted in a lower number of ADR notifications related to contact allergy reactions.
In addition, the data supporting the efficacy of bufexamac are very limited so the Committee concluded, based on the available data, that the benefits of the medicinal products containing the active substance bufexamac do not outweigh the risks and recommended, therefore, a recall of such medicines from the European Union market.
Bufexamac is a non-steroidal anti-inflammatory medicine in topical formulations for treatment of dermatological diseases (eczema and dermatitis) and proctologic conditions (haemorrhoids and anal fissures). The medicinal products containing bufexamac are available in the EU market since 1970.
Based on the data concerning the development of contact allergy reactions, the German regulatory authority carried out the final benefit-risk re-assessment of bufexamac, which was completed in December 2009, and decided to revoke all marketing authorisations for bufexamac in Germany. In compliance with the EU legislation, such regulatory activity was notified by the German regulatory authority to the EMA's Committee so that the Committee could prepare its own opinion concerning the necessary regulatory activities for the entire territory of the European Union.
In the Republic of Croatia, two medicines containing bufexamac have been approved for marketing: Proctosan and Proctosan Forte (bufexamac, bismuth-subgallate, titanium-dioxide, lidocaine hydrocloride) of the marketing authorisation holder Stada Hemofarm d.o.o. These are topical pharmaceutical forms (ointment and suppositories) that have approved indications for proctologic conditions (grade I and II haemorrhoids, anal fissures, i.e. acute anal fissure, acute and chronic anal eczema, inflammation processes in the anal and rectal areas, i.e. proctitis).
The Agency for Medicinal Products and Medical Devices (HALMED) has not received any bufexamac-related ADR notifications, which may be the result of the earlier mentioned failure to recognise the symptoms of an allergic reaction.
The HALMED initiated the review process of the EMA's recommendation. Physicians are recommended not to prescribe these medications, and pharmacists not to dispense them. Also, the HALMED will not be granting any new approvals for exceptional import of the medicinal products containing bufexamac (e.g. Parfenac) prescribed by medical doctors.
Recommendations for physicians, pharmacists and patients:
- Physicians should stop prescribing medicines containing bufexamac, and consider instead other forms of treatment;
- Pharmacists should stop dispensing medicines containing bufexamac;
- Patients who are currently taking medicines containing bufexamac should contact their physician about changing their therapy and finding an adequate one; and
- In case of any dilemma, patients should contact their physician or pharmacist.
Recommendations for other forms of treatment of mild forms of proctologic conditions:
- Dietary measures that are basic and often sufficient, which involve bowel regulation measures (easing the passage of stools by changing the stool consistency and number, adopting an appropriate diet and taking liquids);
- Avoid sitting for long periods of time;
- Adequate hygiene of the anal region;
- Application of sitz baths with clean, warm (but not hot) water for 10-15 minutes after bowel movement and when necessary; and
- Application of anti-haemorrhoidals for topical application (ATK: C05A) which do not contain bufexamac, in conformity with approved indications and dispensing method.
The HALMED will continue monitoring the safety of the medicinal products containing the active substance bufexamac and inform the public in due time about the necessary regulatory activities.
The full text of the EMA's statement is available here.