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FDA Warns Guilford Against Misleading
Advertising
NEW YORK (Reuters) Oct 02 - The US Food and Drug Administration has ordered Guilford Pharmaceuticals Inc. to stop disseminating misleading promotional materials for its Gliadel brain cancer treatment. The FDA sent a letter, which was released on the agency's Web site on Thursday, accusing Guilford of overstating the efficacy and minimizing the risk of treatment with the Gliadel Wafer in a video sent to physicians. The Gliadel Wafer is a device inserted into the cavity created when a surgeon removes a brain tumor. The FDA said side effects of the treatment include seizures, brain edema, healing abnormalities, and intracranial infection. "The videotape implies that many adverse events observed in clinical trials are no longer risks of using the Gliadel Wafer," the FDA said in its letter. "FDA is not aware of any data to support this claim." The agency also took issue with a claim made in the video that the Gliadel Wafer "made a remarkable improvement in survival." The claim is misleading "because it suggests a greater survival benefit than has been demonstrated by substantial evidence or substantial clinical experience," the FDA said. The FDA said Guilford should "immediately cease the dissemination of this and other promotional materials" and submit a written response by Oct. 10 of its intent to comply. |
All written word is "The Opinion" of Thomas A. unless otherwise noted...
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