Vancomycin-containing medicines - referral

Current status

European Commission final decision

Overview

EMA recommends changes to prescribing information for vancomycin antibiotics

Changes aim to ensure appropriate use in context of fight against antimicrobial resistance

On 19 May 2017, the European Medicines Agency (EMA) recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria.

Vancomycin has been used since the 1950s and to this day it remains an important therapeutic option for the treatment of serious infections.The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data on vancomycin medicines given by infusion (drip) and injection and taken by mouth as part of its strategy to update the product information of old antibacterial agents in the context of the fight against antimicrobial resistance.

The CHMP concluded that infusion of vancomycin can continue to be used for the treatment of serious infections caused by certain bacteria including MRSA (meticillin-resistant Staphylococcus aureus) in patients of all ages. Vancomycin can also be used to prevent bacterial endocarditis (an infection in the heart) in patients undergoing surgery and to treat infections in patients undergoing a procedure called peritoneal dialysis. When taken by mouth, use should be limited to the treatment of Clostridium difficile infections (CDI).

Because the available data do not adequately support the use of vancomycin in the treatment of staphylococcal enterocolitis (inflammation of the gut caused by S. aureus) and its use to clear the gut of bacteria in patients with a weakened immune (defence) system, the CHMP concluded that vancomycin should no longer be used for these indications.

In addition, the Committee reviewed the recommended dosage for vancomycin for the various indications and patient groups, and concluded that the starting dose of vancomycin by infusion should be calculated according to the age and weight of the patient. The updated recommendations are based on data which showed that the previously recommended dose often resulted in less than optimal levels of vancomycin in the blood, reducing the effectiveness of the antibiotic.

Information for patients

• Vancomycin is an antibiotic used for serious infections, often caused by bacteria that have become resistant to other treatments. It is given as an infusion (drip) into a vein or by injection in the abdomen (belly). It can also be taken by mouth (as capsules or liquid) to treat an infection of the lining of the gut caused by bacteria called Clostridium difficile.
• The available information on vancomycin has been reviewed and recommendations have been made on its safe use and appropriate dosage.
• The product information for medicines containing vancomycin will be updated to take these recommendations into account.
• Patients who have any questions about their treatment should talk to their doctor or pharmacist.

Information for healthcare professionals

The Agency's recommendations are based on a review of the available pharmacological and clinical data for vancomycin. The product information for vancomycin will be updated to reflect the following:

Vancomycin solution for infusion

• Vancomycin solution for infusion can be used in patients of all ages for the treatment of complicated soft-tissue infections, bone and joint infections, community- and hospital-acquired pneumonia (including ventilator-associated pneumonia), infective endocarditis, acute bacterial meningitis, and bacteraemia associated with the above infections. It can also be used for perioperative prophylaxis in patients at risk of developing bacterial endocarditis and for the treatment of peritoneal dialysis-associated peritonitis.
• The recommended starting dose of vancomycin solution for infusion should be based on the age and weight of the patient. Available data showed that the previously recommended daily dose often resulted in suboptimal vancomycin serum concentrations.
• Any subsequent dose adjustments should be based on serum concentrations to achieve the target therapeutic concentrations.
• Vancomycin parenteral formulations authorised for oral use can be used by mouth in patients of all ages for the treatment of Clostridium difficile infection (CDI).
• Vancomycin parenteral formulations authorised for intraperitoneal use can be used in patients of all ages for the treatment of peritoneal dialysis-associated peritonitis.

Vancomycin capsules

• The available data do not adequately support the use of oral vancomycin in the treatment of staphylococcal enterocolitis and for the decontamination of the GI tract in immunocompromised patients. Therefore, oral vancomycin should no longer be used in these indications.
• Vancomycin capsules can be used in patients aged 12 years and older for the treatment of CDI. For younger children, the use of age-appropriate formulations is recommended.
• The maximum dose should not exceed 2 g per day.
• In patients with inflammatory intestinal disorders, the serum concentration of vancomycin after oral administration should be closely monitored.

More about the medicine

Vancomycin is one of a group of antibiotics known as glycopeptides. It is given by infusion (drip) into a vein to treat serious infections due to Gram-positive bacteria such as meticillin-resistant Staphylococcus aureus (MRSA) that are resistant to other antibiotics, or in patients in whom other antibiotics cannot be used. It can also be used for perioperative prophylaxis in patients at risk of developing bacterial endocarditis and for the treatment of peritoneal dialysis-associated peritonitis.

Vancomycin is also given by mouth to treat infections caused by Clostridium difficile, which mostly develop in hospital patients treated with other antibiotics.

Vancomycin-containing medicines have been authorised nationally in the EU for many years, as Vancocin and a variety of other names.

More about the procedure

The review of vancomycin-containing medicines was initiated on 1 April 2016 at the request of the Spanish medicines agency (AEMPS), under Article 31 of Directive 2001/83/EC.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 21/09/2017.

Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics

Reference Number: EMA/645879/2017Summary:

Changes aim to ensure appropriate use in context of fight against antimicrobial resistance

Key facts

About this medicine

• Approved name:
  Vancomycin-containing medicines
• International non-proprietary name (INN) or common name:
  vancomycin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-31/1440
• Type:
  Article 31 referrals

  This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Key dates and outcomes

• CHMP opinion date:
  18/05/2017
• EC decision date:
  21/09/2017

All documents

Procedure started

Vancomycin Article-31 referral - Annex I

Reference Number: EMA/258475/2016

Vancomycin Article-31 referral - Review started

Reference Number: EMA/222696/2016

Vancomycin Article-31 referral - CHMP list of questions

Reference Number: EMA/CHMP/224042/2016

Vancomycin Article-31 referral - Timetable for the procedure

Reference Number: EMA/CHMP/224121/2016 Rev. 2

Vancomycin Article-31 referral - Notification

Reference Number: EMA/CHMP/224121/2016

Opinion provided by Committee for Medicinal Products for human Use

Vancomycin Article-31 referral - Annex III

European Commission final decision

Vancomycin Article-31 referral - Assessment report

Reference Number: EMA/645288/2017

Vancomycin Article-31 referral - Annex II

Vancomycin Article-31 referral - EMA recommends changes to prescribing information for vancomycin antibiotics

Reference Number: EMA/645879/2017Summary:

Changes aim to ensure appropriate use in context of fight against antimicrobial resistance

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.