LONDON, March 7, 2007-The Medicines and Healthcare products Regulatory Agency (MHRA) has requested Pfizer to withdraw an advertisement making potentially misleading claims about Zyvox (linezolid), an antibiotic used to treat certain types of serious infection.
The MHRA became aware of the advertisement in the British Medical Journal (BMJ) claiming that Zyvox has superior cure rates compared to products containing the active ingredient vancomycin. At the time, Pfizer was in discussion with the MHRA about emerging concerns relating to the efficacy and safety of Zyvox compared to vancomycin in a clinical trial in patients with catheter-related infections.
Pfizer wrote to healthcare professionals this week to inform them about new safety restrictions on the use of Zyvox.
Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA, said:
“Advertising is an important means of communication and for medicines it can provide useful information to the public and healthcare professionals about available treatments and their potential benefits. Companies must take a responsible approach to safety in their advertising in light of the risks and benefits of their product.”
“The MHRA continually monitors the safety of all medicines and takes action to minimise any risks that are identified. The monitoring of advertising is no less important, and the MHRA will not tolerate medicines advertising that creates unrealistic expectations or is misleading.”
Notes to Editor
The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.
Anyone who has concerns about misleading advertising of medicines should contact the MHRA Advertising Unit, 14-112, Market Towers, Vauxhall, London SW8 5NQ or phone 020 7084 2000. Alternatively, contact the pharmaceutical self-regulatory bodies, the Proprietary Association of Great Britain (PAGB) for advertising for over the counter medicines, or the Prescription Medicines Code of Practice Authority (PMCPA) for advertisements to health professionals for prescription medicines.
More information can be found on our website under http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=165