Jul 19, 2002
NEW YORK (Reuters Health)
The US Food and Drug Administration (FDA) has informed Pfizer Inc. that a model of the human brain that the company has used in promoting its anticonvulsant drug Neurontin (gabapentin) violates the agency's regulations.
According to the agency, one side of the model shows the structure of the human brain, while the other side purports to show Neurontin's mechanism of action by illustrating the cellular activity resulting from administration of the drug. The model is prominently marked with the drug's name, the FDA said.
In a letter released on July 1 and posted on the agency's Web site this week, the FDA argued that the model "suggest[s] that the mechanism of action of Neurontin has been established in the human brain," when the drug's approved labeling in fact states that its method of action is unknown.
In addition, the model -- which shows the brain's hippocampus, cerebellum, lower medullary structures and cerebrum -- suggests that the drug is effective for "any specific or non-specific brain disorder thought to involve the GABA-ergic neurotransmitter system that can originate in these parts of the brain," the letter states. There is not substantial evidence to back up such a claim, the agency said.
Finally, the FDA took issue with "the solo and prominent mention of Neurontin" on the model, which it said misleadingly implies that the drug is approved as monotherapy for brain disorders. In fact, it is approved for partial seizures as adjunctive therapy only, the agency said.
The letter asks Pfizer to discontinue the use of the model.
© 2002 Reuters Ltd