FDA Cites SmithKline Beecham For Misleading Bactroban Ad

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.

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