FDA Cites SmithKline Beecham For Misleading Bactroban Ad

Jan. 13, 2005
The FDA has cited SmithKline Beecham for disseminating misleading promotional materials for Bactroban Nasal, a product used to eradicate methicillin-resistant Staphylococcus aureus (MRSA). Staphylococcus aureus is a bacterium that generally spreads in ...

The FDA has cited SmithKline Beecham for disseminating misleading promotional materials for Bactroban Nasal, a product used to eradicate methicillin-resistant Staphylococcus aureus (MRSA). Staphylococcus aureus is a bacterium that generally spreads in hospitals, resulting in wound, pneumonia, respiratory, and urinary tract infections. Methicillin is a commonly used antibiotic to treat Staphylococcus infections. SmithKline made statements regarding the effectiveness of its product on a hospital display panel. These statements included: "Stop Methicillin Resistant Staphylococcus where they originate;" "Infection protection in a tube;" and "In a hospital study, Bactroban Nasal contributed to a dramatic reduction in MRSA infections and Vancomycin costs during an outbreak." Although these statements may be true, SmithKline failed to include information related to the drug's side effects, contraindications, and warnings, the FDA said. Under FDA regulations, "Promotional materials must present information relating to side effects, contraindications, and warnings with a prominence and readability reasonably comparable with any presentation of information relating to the use or efficacy of the drug." SmithKline must now immediately discontinue the use of this and any other similar promotional materials or face possible regulatory action, the agency said.

Popular Sponsored Recommendations

Empowering the Modern Workforce: The Power of Connected Worker Technologies

March 1, 2024
Explore real-world strategies to boost worker safety, collaboration, training, and productivity in manufacturing. Emphasizing Industry 4.0, we'll discuss digitalization and automation...

3 Best Practices to Create a Product-Centric Competitive Advantage with PRO.FILE PLM

Jan. 25, 2024
Gain insight on best practices and strategies you need to accelerate engineering change management and reduce time to market. Register now for your opportunity to accelerate your...

Transformative Capabilities for XaaS Models in Manufacturing

Feb. 14, 2024
The manufacturing sector is undergoing a pivotal shift toward "servitization," or enhancing product offerings with services and embracing a subscription model. This transition...

Shifting Your Business from Products to Service-Based Business Models: Generating Predictable Revenues

Oct. 27, 2023
Executive summary on a recent IndustryWeek-hosted webinar sponsored by SAP

Voice your opinion!

To join the conversation, and become an exclusive member of IndustryWeek, create an account today!