Pharmaceutical Company Ordered to Withdraw Advertising
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 promptly suspended all advertising containing this claim. The MHRA advised Pfizer that they need to continually review their advertising in the light of current information on the balance of risks and benefits for their products, and take appropriate action if new safety data becomes available.
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
Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk
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